Venipuncture in pediatric emergency department by using Koala Attachment Distraction method: Randomized clinical trial

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Fernández-Merino, Laura Larena-Fernández, María López-Cabrejas, Josep Oriol Casanovas-Marsal" "autores" => array:6 [ 0 => array:4 [ "nombre" => "Iria" "apellidos" => "Quintela-Sánchez" "email" => array:1 [ 0 => "imquintela@salud.aragon.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "Nieves" "apellidos" => "Gasca-Roche" ] 2 => array:2 [ "nombre" => "Tania" "apellidos" => "Fernández-Merino" ] 3 => array:2 [ "nombre" => "Laura" "apellidos" => "Larena-Fernández" ] 4 => array:2 [ "nombre" => "María" "apellidos" => "López-Cabrejas" ] 5 => array:2 [ "nombre" => "Josep Oriol" "apellidos" => "Casanovas-Marsal" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Urgencias Pediátricas del Hospital Universitario Miguel Servet, Zaragoza, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Venopunción en Urgencias Pediátricas mediante método de Distracción con Apego Koala: ensayo clínico aleatorizado" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 2669 "Ancho" => 2508 "Tamanyo" => 321043 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0045" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Participation flow diagram." ] ] ] "textoCompleto" => "<elsevierMultimedia ident="tb0005"></elsevierMultimedia>IntroductionThe most frequently used technique in the paediatric emergency department (PED) is venipuncture.<a class="elsevierStyleCrossRef" href="#bib0005">1</a> Venipuncture is the process of obtaining intravenous access for blood extraction and/or the administration of intravenous treatment. It is therefore the invasive procedure that most often causes pain, fear and stress in children.<a class="elsevierStyleCrossRefs" href="#bib0005">1–5</a>Pain assessment and its subsequent treatment are the focus of nursing care, since quality of care may be improved through them.<a class="elsevierStyleCrossRef" href="#bib0030">6</a> However, they continue to be under-diagnosed, despite proof of their negative impact in the short and long term, especially in children who use the emergency services.<a class="elsevierStyleCrossRefs" href="#bib0035">7–10</a>Inadequate management of pain, stress, anxiety and fear during clinical procedures in childhood may reduce individual tolerance of them and contribute to the development of phobias throughout adult life.<a class="elsevierStyleCrossRefs" href="#bib0055">11,12</a>The management of pain and stress should be comnbined because they are linked together, with an additional focus on the prevention of anticipatory stress, which emotionally influences parents, generating anxiety.<a class="elsevierStyleCrossRefs" href="#bib0015">3,13–15</a>Parental presence can reassure the child during procedure explanation, and may be beneficial.<a class="elsevierStyleCrossRef" href="#bib0075">15</a> However, there is insufficient evidence regarding its impact on the child’s stress.<a class="elsevierStyleCrossRef" href="#bib0020">4</a> Controversy surrounds this relationship since, although the evidence supports parental presence, in some studies greater stress of the child is observed when they are faced with anxious behaviour from the parents.<a class="elsevierStyleCrossRefs" href="#bib0020">4,14–16</a>PEDs are provided with pharmacological and non-pharmacological measures for pain relief.<a class="elsevierStyleCrossRefs" href="#bib0055">11,16,17</a> Pharmacological measures include topical anesthetics such as lidocaine hydrochloride with adrenaline and tetracaine hydrochloride or lidocaine prilocaine, which are of little applicability in urgent clinical procedures because their capacity for action requires long periods of time.<a class="elsevierStyleCrossRefs" href="#bib0025">5,6,16</a>Non-pharmacological methods have a low incidence of adverse effects and can be useful for managing parental anxiety.<a class="elsevierStyleCrossRefs" href="#bib0055">11,12</a> They are used in accordance with the child’s age group.<a class="elsevierStyleCrossRef" href="#bib0090">18</a>In neonates and infants there is evidence of a reduction in pain, restlessness and crying, through non-nutritive sucking (with a dummy) and/or nutritive sucking (with breastfeeding, artificial feeding or 24% oral sucrose solution), as well as with parental attachment through physical contact (kangaroo or skin-to-skin method).<a class="elsevierStyleCrossRef" href="#bib0090">18</a>From early childhood (over 1year) behavioural distraction of the child is required through a variety of methods such as: videos; music; conversation; Valsalva manoeuvres; virtual reality; games; stories; cards; the application of heat and cold, and vibrations.<a class="elsevierStyleCrossRefs" href="#bib0030">6,11,16,17</a>,<a class="elsevierStyleCrossRef" href="#bib0095">19</a>One of the least studied is the Koala Attachment Distraction (KAD) method. The objectives of this study were therefore to assess and compare the pain and stress of the child (3 to 4 years) in venipuncture between the Koala Attachment Distraction (KAD) method and the physical restraint method. Also, to evaluate the level of anxiety perceived by the companions in both groups.MethodsStudy designRandomised, parallel-group, single-blind clinical trial divided into a control group and an intervention group for the evaluation of pain and stress during venipuncture in paediatric patients and the assessment of anxiety perceived by companions. The study was registered in ClinicalTrials.gov (NCT05453305).Participants, recruitment and sample calculationThe participation and inclusion of 220 patients between the ages of 3 and 4 years was initially calculated (power of .8, 95% confidence interval and margin of error of 5% of 516 patients who received a venipuncture in 2020 aged between 3–4 years), randomly and homogeneously distributed into a control group (n=110) and an intervention group (n=110) who attended the PED of the Miguel Servet University Hospital in Zaragoza (Aragon, Spain) from June 1, 2021 to May 30, 2022.The patients classified as level I, II, and/or classified as minimum wait; children with psychomotor retardation; with special needs; with a diagnostic pathology of cancer or carriers of a subcutaneous reservoir; with diabetes mellitus or other pathologies that involve alterations in skin sensitivity; with disability for language comprehension and expression (language barrier); with previous administration of analgesic, sedative or relaxants and previous venipuncture less than 24hours were excluded from the study, even for sample recruitment.InterventionsThe study participants were assigned to the control group (COG) and the intervention group (ING) by consecutive sampling and subsequent randomisation. The patients in the COG lay on the bed in a supine position, with their companion and with the limb to be punctured in a downward position. During the technique, the companion was present and could participate by using consolation or distraction, as usually occurs in the PED. At the same time, a professional from the service was in charge of holding the chosen limb, as well as the opposite one. The nurse in charge performed the venipuncture (for blood extraction and/or placement of a peripheral vascular catheter) while another colleague helped with holding and/or collecting samples. A trained nurse assessed the child’s pain and stress before and during the procedure.The patients in the ING clinic sat with their companion on a chair, with the child on top facing the companion, with one leg on each side and the arms resting on the companion’s shoulders. The patient's head rested on the adult's shoulder, contralateral to the limb to be punctured. At the same time, the responsible adult held the patient in a hug-like manner. A professional was in charge of immobilising the limb chosen for puncture. The nurse in charge performed the venipuncture (for blood extraction and/or placement of a peripheral vascular catheter) while another professional assisted with the holding and/or sample collection tasks (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). A trained nurse assessed the child's pain and stress before and during the procedure.<elsevierMultimedia ident="fig0005"></elsevierMultimedia>Outcome variablesWhen study participants were included, the following variables were recorded for the paediatric participant for both study groups (COG and ING): age and sex, pain before venipuncture, pain during venipuncture; using the Face, Leg, Activity, Cry, Consolability (FLACC) pain assessment scale).<a class="elsevierStyleCrossRef" href="#bib0100">20</a> The FLACC scale assesses pain through manifestations of facial expressions, leg movement, activity, crying and whether the patient can be consoled. Each of these categories is assessed on a score range of 0, 1 and 2. The total sum is the result of pain from 0 to 10 points.Paediatric stress was assessed before venipuncture and during venipuncture using the Groningen distress scale<a class="elsevierStyleCrossRef" href="#bib0075">15</a> for the assessment. The Groningen distress scale assesses paediatric stress in 5 categories (calm without crying, tension without crying, tension and crying, tension and continuous crying, agitation, shouting and physical resistance). The overall result is a stress range between one and five. The type of venipuncture performed was also recorded: peripheral intravenous cannulation or blood test extraction.Regarding the parents, the variables of sex, age and number of children were recorded. At the same time, the anxiety perceived by the companions was assessed by giving them the State/Trait Anxiety Questionnaire (STAI),<a class="elsevierStyleCrossRef" href="#bib0105">21</a> so that they could complete it with their perceived sensations before and during the technique. This questionnaire assesses anxiety at a specific moment through twenty questions with Likert-type answers (0–3). The higher the score obtained as a result, the higher the level of perceived anxiety.The entire nursing team of the PED at the Miguel Servet University Hospital in Zaragoza received 4 training sessions regarding the use and application of the pain assessment scales, child stress, and anxiety perceived by companion tools.Randomisation and maskingSimple randomisation was performed at a 1:1 ratio by consecutive sampling, respecting the balance between both study groups (intervention group and control group) at a proportion level of 50%. Randomisation was performed by an independent evaluator, with no other involvement in the trial, using a computerised randomisation system (Working in Epidemiology: <a href="http://www.winepi.net/">http://www.winepi.net/</a>). Allocation concealment was guaranteed by means of sealed, opaque, sequentially numbered envelopes. When the participating patient agreed to be included in the study, the envelope was opened and the patient was assigned to either the control or intervention group. Due to the nature of the intervention, the participating patients were not blinded to the intervention. To minimize bias between groups, a prior assessment of pain, stress of the child and anxiety perceived by the companions was performed.The person in charge of statistical analysis performed the analysis with coded variables without knowing whether the participants had been allocated to the COG or ING.Statistical methodsData analysis was performed using the Jamovi® 2.2.2 statistical calculation programme. Due to the difficulty in recruiting for the study, an interim analysis was performed following Pocock’s and O’Brien’s rules and adjusting the level of statistical significance (p<.02). The descriptive analysis of the data for qualitative variables was presented by the frequency distribution of the percentages for each category. The quantitative variables studied have been explored by the goodness-of-fit test for a normal distribution (Kolmogorov-Smirnov test) and indicators of central tendency (mean or median) and dispersion (standard deviation or interquartile range) are given. The association between quantitative and qualitative variables was studied by means of hypothesis contrast tests with comparison of means (Mann-Whitney U test and Kruskall-Wallis test).For the paired sample association, the Wilcoxon W test was used and for the bivariate correlations, the Spearman correlation coefficient. The relationship of each variable, controlling the possible effect of third variables, was completed, for each study group, by means of the linear regression model. All effects were considered significant if p<.02.Ethical aspectsRegarding the ethics of the participation process, after a written and verbal description of all the information related to the study and its objectives (Participant Information Sheet) to the parents/mothers/companions, those who agreed to participate signed the informed consent. The inclusion of participants in the database was anonymous and confidential. During the study, national and international guidelines were followed (code of ethics, Declaration of Helsinki). Likewise, the humanisation of care was promoted, complying with the European Charter for Hospitalised Children, approved by the European Parliament in 1986, which regulates the right of children to be accompanied. The study was approved by the Ethics and Research Committee of the Autonomous Community of Aragon (PI21/218).ResultsFour hundred and fifty children were evaluated for participation from June 1, 2021 to May 31, 2022, of which 113 met the inclusion criteria. The final participation was 110 participants (3 of them were excluded for not having completed the STAI scale) (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>). The participants were homogeneously and randomly distributed in the COG (55) and in the ING (55).<elsevierMultimedia ident="fig0010"></elsevierMultimedia>The mean age of the 110 participants was 3.83±.587 [95% CI: 3.72–3.94] and that of their companions was 37.17±6.957 [95% CI: 35.87–38.47]. Fifty per cent of the participants were girls. Regarding the family unit, the mean number of children per family was 1.88±.854 [95% CI: 1.72–2.04]. According to the family members’ accompaniment, 23.6% of the children who went to the emergency department did so with the father, 74.5% with the mother, and 1.8% of them with other companions. According to the registered technique, 20.9% of the children underwent blood tests and 79.1% underwent peripheral intravenous cannulation. Regarding the sociodemographic variables, no statistically significant differences were found between COG and ING in the age of the child (3.84±.59 [95% CI: 3.68–3.99] vs. 3.82±.59 [95% CI: 3.66–3.98]), in sex [boy: 27.27% (30) vs. 22.73% (25); girl: 22.73% (25) vs. 27.27% (30); χ2:.91, p=.34], in the age of the companions (36.83±7.20 [95% CI: 34.89–38.78] vs. 37.50±6.75 [95% CI: 35.68–39.33]) and the number of children per family (1.82±.72 [95% CI: 1.62–2.01] vs. 1.95±.97 [95% CI: 1.68–2.21]).In relation to the general study sample, the mean pain rating of the child before venipuncture was 1.70±2.775 [95% CI: 1.18–2.22], and during venipuncture it was 4.75±3.271 [95% CI: 4.14–5.37] (Wilcoxon W: 210; p=<.001). The mean stress value of the child before the technique was 1.63±1.074 [95% CI: 1.43–1.83] and during venipuncture it was 2.96±1.263 [95% CI: 2.73–3.20] (Wilcoxon W: 109; p=<.001). Regarding the assessment of anxiety perceived by parents before and during venipuncture, the mean was 24.32±13.427 [95% CI: 21.81–26.83] and 24.02±12.853 [95% CI: 21.62–26.42], respectively (Wilcoxon W: 2448; p=.666). No statistically significant differences were found between the assessment of pain and stress according to sex or venipuncture technique. Regarding the assessment of pain, stress and anxiety perceived by companions before venipuncture, no statistically significant differences were found between the GCO and the GIN (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>In the assessment of pain, stress and anxiety perceived by companions during venipuncture between the COG and the ING, statistically significant differences were found between pain and stress. Regarding the sample size and power for comparison of independent means, with pain being the variable of study, the statistical power was 83.6% (CI 95%). However, no statistically significant differences were found in the assessment of anxiety perceived by companions between the COG and the ING (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).Strong correlations were found between pain and stress before and during venipuncture in the COG (Spearman: .892; p=<.001 and Spearman: .898; p=<.001, respectively) and a moderate correlation between pre-venipuncture stress and pain during venipuncture (Spearman: .599; p=<.001).Strong correlations were found between pain and stress before venipuncture in the ING (Spearman: .802; p=<.001) and during venipuncture (Spearman: .857; p=<.001). Moderate correlations between prior stress and pain during venipuncture (Spearman: .451; p=<.001), between prior anxiety and pain during venipuncture (Spearman: .330; p=.014), between pain and anxiety during the procedure (Spearman: .428; p=.001) and between stress and anxiety during the procedure (Spearman: .423; p=.001).The prediction of pain during the KAD intervention based on the anxiety of the companion and the stress of the child during the technique suggests an association r=.839. When extrapolated to the general population matching the same inclusion criteria, 70.4% would behave according to our model (DurFLACC=−1.7838+.0226*DurSTAI and DurFLACC=−1.7838+1.9229*DurGron). In the case of the COG technique, the expected pain during it has an even more perfect association r=.911, so that a percentage of 83.1% would behave as expected (DurFLACC=−2.6825+.0115*DurSTAI and DurFLACC=−2.6825+2.4672*DurGron).DiscussionThis study assesses and compares pain and stress in children during venipuncture using the KAD method and the physical restraint method, as well as the anxiety perceived by those accompanying them in the PED.Pain in children continues to be poorly assessed and treated, especially during the techniques that cause the most pain, such as procedures with needles.<a class="elsevierStyleCrossRefs" href="#bib0035">7,22–24</a>The results of this study show that patients undergoing venipuncture using the KAD method have a significantly lower level of pain than those who received physical restraint. Multiple studies that assess pain during venipuncture exist, using both the Wong-Baker Face Scale and the FLACC scale, showing that the use of different distraction techniques is more effective in reducing pain than the usual restraint methods. The study by Balliel<a class="elsevierStyleCrossRef" href="#bib0050">10</a> measured pain using the Wong-Baker Face Scale, obtaining less pain in the intervention group (playing with bubbles) than in the control group (in which no distraction measurement was performed).<a class="elsevierStyleCrossRef" href="#bib0050">10</a> The findings of Suleman et al.<a class="elsevierStyleCrossRef" href="#bib0060">12</a> concluded that pain, also assessed with the Wong-Baker Face Scale, decreases significantly when using distraction with colouring pictures, compared to inflating balloons or forcing a cough.<a class="elsevierStyleCrossRef" href="#bib0060">12</a> The study carried out by Lee et al.<a class="elsevierStyleCrossRef" href="#bib0125">25</a> assesses pain using the FLACC scale and comparing virtual reality with routine venipuncture on a bed, without obtaining significant results, but with a lower average pain in the intervention group.<a class="elsevierStyleCrossRef" href="#bib0125">25</a>This study shows that venipuncture using the KAD method generates a significantly lower level of stress than those who receive physical restraint. Regarding the above, the study by Dumoulin et al.<a class="elsevierStyleCrossRef" href="#bib0010">2</a> on the pain-stress cycle, which relates the perception of pain with the increase in stress, agrees with the conclusions obtained in this present clinical trial.<a class="elsevierStyleCrossRef" href="#bib0010">2</a>It is important to distinguish stress from anxiety: stress is considered to be the physiological reaction to a dangerous situation, while anxiety is an emotional response without the need for a specific stimulus. However, in numerous studies on venipuncture in paediatrics, both terms are used interchangeably, as well as different scales. Ankan et al.<a class="elsevierStyleCrossRef" href="#bib0130">26</a> compared active distraction with passive distraction and no distraction, using the Children’s Fear Scale (CFS) to assess children’s anxiety, obtaining significant differences during venipuncture between the groups, which matches our results.<a class="elsevierStyleCrossRef" href="#bib0130">26</a> Osmanlliu et al.<a class="elsevierStyleCrossRef" href="#bib0115">23</a> used the CFS scale for anxiety and the Procedure Behaviour Check (PBC) for stress, obtaining lower results in both variables in the intervention group, the difference being non-significant.<a class="elsevierStyleCrossRef" href="#bib0115">23</a> The study by Balliel<a class="elsevierStyleCrossRef" href="#bib0050">10</a> measured anxiety using the CFS scale, obtaining less anxiety in the intervention group than in the control group.<a class="elsevierStyleCrossRef" href="#bib0050">10</a>The application of non-pharmacological measures (music therapy, contact with parents, Buzzy® vibration and local cold devices, videos or toys) to reduce pain and stress is scarce because it is not standardised.<a class="elsevierStyleCrossRefs" href="#bib0010">2,4,11,17</a>,<a class="elsevierStyleCrossRefs" href="#bib0095">19,26–29</a> All of them reduce the patient’s pain by modifying the focus of attention according to The Gate Control Theory of Pain.<a class="elsevierStyleCrossRef" href="#bib0135">27</a> Among the non-pharmacological measures, the most frequent distraction method is the electronic device,<a class="elsevierStyleCrossRef" href="#bib0010">2</a> used in numerous studies, such as the one cobnducted by Lee et al.<a class="elsevierStyleCrossRef" href="#bib0125">25</a> or Osmanlliu et al.<a class="elsevierStyleCrossRef" href="#bib0115">23</a> Another non-pharmacological measure is the child being in contact with and held by someone in their environment, which is why the KAD method reduces their stress and pain levels. In the study by Trottier et al.,<a class="elsevierStyleCrossRef" href="#bib0150">30</a> 60% of the hospitals surveyed offered the possibility of venipuncture in children held by their parents. Furthermore, 33% of hospitals that did not offer it were considering including it in their unit.<a class="elsevierStyleCrossRef" href="#bib0150">30</a>Pharmacological pain management using topical anaesthetics is of little applicability, despite being strongly recommended, as it requires a long action time to be effective.<a class="elsevierStyleCrossRef" href="#bib0065">13</a> Therefore, the inclusion of non-pharmacological methods of pain relief prior to invasive techniques is essential.<a class="elsevierStyleCrossRef" href="#bib0045">9</a> Currently, Ballard et al.<a class="elsevierStyleCrossRef" href="#bib0120">24</a> are conducting a non-inferiority clinical trial comparing the Buzzy® device with the local application of 4% lidocaine.<a class="elsevierStyleCrossRef" href="#bib0120">24</a>With regard to companions, this study shows that anxiety prior to the technique is similar in both groups, while during venipuncture it is higher in the group subjected to physical restraint. In the study by Hartling et al.,<a class="elsevierStyleCrossRef" href="#bib0085">17</a> the usual non-pharmacological measures during venipuncture were compared with music therapy, finding no statistically significant differences in parental anxiety. Other more recent studies such as that by García-Aracil et al.,<a class="elsevierStyleCrossRef" href="#bib0055">11</a> relate the increase in parental anxiety with the increase in the child’s stress. When comparing the distraction group with the control group and another distraction group with Buzzy® with the control group, statistically significant differences were found in the assessment of the parents’ anxiety (using the STAI questionnaire).<a class="elsevierStyleCrossRef" href="#bib0055">11</a> In the KAD group, the anxiety perceived by the companions is directly related to the pain and stress perceived by the child, while in the control group there is no relationship between these variables.Two main limitations were detected in this study. The first limitation was the high rate of participation losses due to multifactorial causes and having to adjust the degree of statistical significance. The second limitation of this study is the specificity of the selected age group. The assessment carried out in various clinical conditions could also influence the interpretation of pain.Venipuncture in the PED using the KAD method has been shown to be effective in managing pain and stress in children during the technique in paediatric patients between 3 and 4 years of age. Its introduction into the protocols of our unit is therefore recommended, as well as in the PEDs of other third-level hospitals with a similar context.Two future lines of research are proposed. Firstly, the examination and approach to the anxiety felt by the companion when faced with stressful and painful procedures to the child in an emergency situation. Secondly, the application of the KAD method in a wider age range so that more paediatric patients benefit from this intervention aimed at reducing their pain and stress during an invasive process.FundingThis study received no funding.Conflict of interestThe authors have no conflict of interests to declare." "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres2290531" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Method" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1902942" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres2290532" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Método" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1902941" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0015" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0020" "titulo" => "Methods" "secciones" => array:7 [ 0 => array:2 [ "identificador" => "sec0025" "titulo" => "Study design" ] 1 => array:2 [ "identificador" => "sec0030" "titulo" => "Participants, recruitment and sample calculation" ] 2 => array:2 [ "identificador" => "sec0035" "titulo" => "Interventions" ] 3 => array:2 [ "identificador" => "sec0040" "titulo" => "Outcome variables" ] 4 => array:2 [ "identificador" => "sec0045" "titulo" => "Randomisation and masking" ] 5 => array:2 [ "identificador" => "sec0050" "titulo" => "Statistical methods" ] 6 => array:2 [ "identificador" => "sec0055" "titulo" => "Ethical aspects" ] ] ] 6 => array:2 [ "identificador" => "sec0060" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0065" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0070" "titulo" => "Funding" ] 9 => array:2 [ "identificador" => "sec0075" "titulo" => "Conflict of interest" ] 10 => array:2 [ "identificador" => "xack786066" "titulo" => "Acknowledgement" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2023-12-04" "fechaAceptado" => "2024-07-08" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1902942" "palabras" => array:5 [ 0 => "Phlebotomy" 1 => "Pain management" 2 => "Stress psychological" 3 => "Emergency service hospital" 4 => "Child" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1902941" "palabras" => array:5 [ 0 => "Flebotomía" 1 => "Manejo del dolor" 2 => "Estrés psicológico" 3 => "Servicio de Urgencias en Hospital" 4 => "Niño" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "ObjectiveTo assess, compare and relate the toddler’s pain and anxiety during venipuncture by using either the Koala Attachment Distraction method or the physical restraint method and to evaluate the level of anxiety perceived by the companions in both groups. MethodRandomised, single-blind, controlled clinical trial in two arms (control and intervention group) conducted in the paediatric emergency department of a tertiary university hospital. The study variables were pain and stress of the child and anxiety perceived by the accompanying persons in both groups at the time before and during the technique. The pain rating scale Face, Leg, Activity, Cry, Consolability; the Groningen stress scale and the STAI questionnaire were used. ResultsA total of 113 participants aged 3 to 4 years participated in the trial (n=113). 50% (55) were girls, mean total age 3.83±0.59 years and accompanying persons 37.17±6.96. During the technique the mean pain in control and intervention groups was 5.64±3.30 and 3.87±3.01; stress, 3.25±1.22 and 2.67±1.24, respectively. No statistically significant differences were found in the assessment of anxiety between the groups. ConclusionsPatients who underwent the Koala Attachment Distraction method venipuncture show a lower level of pain and anxiety than those who received physical restraint, and the anxiety perceived by the companion is similar in both groups." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Method" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "ObjetivoValorar, comparar y relacionar el dolor y estrés del niño en la venopunción mediante el método Distracción con Apego Koala y método de contención física y evaluar el nivel de ansiedad percibido por los acompañantes en ambos grupos. MétodoEnsayo clínico aleatorio simple ciego controlado en dos brazos (grupo control e intervención) realizado en el servicio de urgencias pediátricas de un hospital universitario de tercer nivel. Las variables de estudio fueron dolor y estrés del niño y ansiedad percibida por los acompañantes en ambos grupos en el momento previo y durante la técnica. Se usó la escala de valoración del dolor Face, Leg, Activity, Cry, Consolability; la escala de estrés de Groningen y el cuestionario STAI. ResultadosUn total de 113 participantes entre 3 y 4 años participaron en el ensayo (n=113). El 50% (55) fueron niñas, media de edad total 3.83±0.59 años y acompañantes 37.17±6.96. Durante la técnica la media de dolor en grupo control e intervención fue de 5.64±3.30 y 3.87±3.01; de estrés, 3.25±1.22 y 2.67±1.24, respectivamente. No se hallaron diferencias estadísticamente significativas en la valoración de la ansiedad entre los grupos. ConclusionesLos pacientes sometidos a venopunción mediante el método Distracción con Apego Koala presentan un nivel de dolor y estrés inferior a aquellos que recibieron contención física y la ansiedad percibida por el acompañante es similar en ambos grupos." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Método" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "multimedia" => array:4 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1320 "Ancho" => 990 "Tamanyo" => 208219 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0040" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Venipuncture using Koala attachment distraction method." ] ] 1 => array:8 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 2669 "Ancho" => 2508 "Tamanyo" => 321043 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0045" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Participation flow diagram." ] ] 2 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0050" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "CI: Confidence interval; DurSTAI: anxiety perceived by parents during venipuncture; DurFLACC: pain perceived by the child during venipuncture; DurGroningen: stress perceived by the child during venipuncture; IQR: Interquartile range; PreSTAI: anxiety perceived by parents before venipuncture; PreFLACC: pain perceived by the child before venipuncture; PreGroningen: stress perceived by the child before venipuncture; SD: Standard deviation." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_colgroup " rowspan="2" align="left" valign="middle" scope="col" colspan="2" style="border-bottom: 2px solid black"></th><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_colgroup " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">COGN=55 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">INGN=55 \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">P \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td-with-role" title="\n \t\t\t\t\ttable-head\n \t\t\t\t ; entry_with_role_colgroup " colspan="2" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">98% CI</th></tr><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Inferior \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Superior \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">PreSTAI</td><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Mean±SD[95% CI] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24.42±13.00[20.98–27.85] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24.22±13.96[20.52–27.91] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.94</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">−.43</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.46</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Median (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">23 (19.50) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 (19.00) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">PreFLACC</td><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Mean±SD[95% CI] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.69±2.53[1.02–2.36] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.71±3.01[.91–2.51] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.97</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">−.45</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.44</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Median (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 (3.00) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 (2.00) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">PreGroningen</td><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Mean±SD[95% CI] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.67±1.00[1.40–1.94] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1.58±1.15[1.27–1.89] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.66</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">−.36</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.53</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Median (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 (1.00) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 (.00) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">DurSTAI</td><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Mean±SD[95% CI] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25.11±12.61[21.77–28.44] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">22.93±13.11[19.46–26.39] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.38</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">−.27</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.61</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Median (RIC) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">24 (18.00) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">22 (16.50) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">DurFLACC</td><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Mean±SD[95% CI] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5.64±3.30[4.76–6.51] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.87±3.01[3.07–4.67] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.004</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.09</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">1.01</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Median (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 (5.50) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (4.00) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">DurGroningen</td><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Mean±SD[95% CI] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.25±1.22[2.93–3.58] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2.67±1.24[2.34–3.00] \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.015</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.01</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " rowspan="2" align="left" valign="middle">.93</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Median (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (1.00) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 (2.50) \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab3710689.png" ] ] ] ] "descripcion" => array:1 [ "en" => "Analysis of the study variables distributed by the COG (control group) and the ING (intervention group)." ] ] 3 => array:5 [ "identificador" => "tb0005" "tipo" => "MULTIMEDIATEXTO" "mostrarFloat" => false "mostrarDisplay" => true "texto" => array:1 [ "textoCompleto" => "What is knownVenipuncture is one of the techniques that causes the most pain in children. Evidence shows that pain is related to stress. The experience perceived by children when faced with pain can emotionally influence parents, causing anxiety.What it contributesThe Koala Attachment Distraction method is effective in reducing pain and stress in children undergoing venipuncture in emergency services. It is also useful in reducing the anxiety of those accompanying them during venipuncture." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:30 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "An evidence-based approach to minimizing acute procedural pain in the emergency department and beyond" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "S. Ali" 1 => "T. McGrath" 2 => "A.L. Drendel" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1097/PEC.0000000000000669" "Revista" => array:6 [ "tituloSerie" => "Pediatr Emerg Care" "fecha" => "2016" "volumen" => "32" "paginaInicial" => "36" "paginaFinal" => "42" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26720064" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A randomized controlled trial of the use of virtual reality for needle-related procedures in children and adolescents in the emergency department" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "S. Dumoulin" 1 => "S. Bouchard" 2 => "J. Ellis" 3 => "K.L. Lavoie" 4 => "M.P. Vézina" 5 => "P. 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Seddon" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1177/1367493515598643" "Revista" => array:6 [ "tituloSerie" => "J Child Health Care" "fecha" => "2016" "volumen" => "20" "paginaInicial" => "267" "paginaFinal" => "276" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26316521" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "Z. Yu" 1 => "Y. Zhou" 2 => "X. Xu" 3 => "L. Lin" 4 => "Q. Le" 5 => "Y. Gu" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1186/s12887-023-03855-z" "Revista" => array:5 [ "tituloSerie" => "BMC Pediatr" "fecha" => "2023" "volumen" => "23" "paginaInicial" => "58" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/36737707" "web" => "Medline" ] ] ] ] ] ] ] ] 5 => array:3 [ "identificador" => "bib0030" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Individual cartoon video for alleviating perioperative anxiety and reducing emergence delirium in children: a prospective randomised trial" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "X. Tang" 1 => "M. Zhang" 2 => "L. Yang" 3 => "X. Tao" 4 => "Y. Li" 5 => "Y. Wang" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/bmjpo-2023-001854" "Revista" => array:5 [ "tituloSerie" => "BMJ Paediatr Open" "fecha" => "2023" "volumen" => "7" "paginaInicial" => "1" "paginaFinal" => "9" ] ] ] ] ] ] 6 => array:3 [ "identificador" => "bib0035" "etiqueta" => "7" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Procedural Pain Scale Evaluation (PROPoSE) study: protocol for an evaluation of the psychometric properties of behavioural pain scales for the assessment of procedural pain in infants and children aged 6–42 months" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "D.J. Crellin" 1 => "D. Harrison" 2 => "A. Hutchinson" 3 => "T. Schuster" 4 => "N. Santamaria" 5 => "F.E. Babl" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/BMJOPEN-2017-016225" "Revista" => array:3 [ "tituloSerie" => "BMJ Open" "fecha" => "2017" "volumen" => "7" ] ] ] ] ] ] 7 => array:3 [ "identificador" => "bib0040" "etiqueta" => "8" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Pain and pain management in children and adolescents receiving hospital care: a cross-sectional study from Sweden" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "V. Andersson" 1 => "S. Bergman" 2 => "I. Henoch" 3 => "H. Simonsson" 4 => "K. 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Venipuncture in pediatric emergency department by using Koala Attachment Distraction method: Randomized clinical trial

Venopunción en Urgencias Pediátricas mediante método de Distracción con Apego Koala: ensayo clínico aleatorizado

Iria Quintela-Sánchez

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imquintela@salud.aragon.es

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, Nieves Gasca-Roche, Tania Fernández-Merino, Laura Larena-Fernández, María López-Cabrejas, Josep Oriol Casanovas-Marsal

Servicio de Urgencias Pediátricas del Hospital Universitario Miguel Servet, Zaragoza, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0240" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="tb0005"></elsevierMultimedia></p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Introduction</span><p id="par0015" class="elsevierStylePara elsevierViewall">The most frequently used technique in the paediatric emergency department &#40;PED&#41; is venipuncture&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Venipuncture is the process of obtaining intravenous access for blood extraction and&#47;or the administration of intravenous treatment&#46; It is therefore the invasive procedure that most often causes pain&#44; fear and stress in children&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#8211;5</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Pain assessment and its subsequent treatment are the focus of nursing care&#44; since quality of care may be improved through them&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> However&#44; they continue to be under-diagnosed&#44; despite proof of their negative impact in the short and long term&#44; especially in children who use the emergency services&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#8211;10</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Inadequate management of pain&#44; stress&#44; anxiety and fear during clinical procedures in childhood may reduce individual tolerance of them and contribute to the development of phobias throughout adult life&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#44;12</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The management of pain and stress should be comnbined because they are linked together&#44; with an additional focus on the prevention of anticipatory stress&#44; which emotionally influences parents&#44; generating anxiety&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;13&#8211;15</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">Parental presence can reassure the child during procedure explanation&#44; and may be beneficial&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> However&#44; there is insufficient evidence regarding its impact on the child&#8217;s stress&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Controversy surrounds this relationship since&#44; although the evidence supports parental presence&#44; in some studies greater stress of the child is observed when they are faced with anxious behaviour from the parents&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;14&#8211;16</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">PEDs are provided with pharmacological and non-pharmacological measures for pain relief&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#44;16&#44;17</span></a> Pharmacological measures include topical anesthetics such as lidocaine hydrochloride with adrenaline and tetracaine hydrochloride or lidocaine prilocaine&#44; which are of little applicability in urgent clinical procedures because their capacity for action requires long periods of time&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6&#44;16</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">Non-pharmacological methods have a low incidence of adverse effects and can be useful for managing parental anxiety&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11&#44;12</span></a> They are used in accordance with the child&#8217;s age group&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">In neonates and infants there is evidence of a reduction in pain&#44; restlessness and crying&#44; through non-nutritive sucking &#40;with a dummy&#41; &#8203;&#8203;and&#47;or nutritive sucking &#40;with breastfeeding&#44; artificial feeding or 24&#37; oral sucrose solution&#41;&#44; as well as with parental attachment through physical contact &#40;kangaroo or skin-to-skin method&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">From early childhood &#40;over 1<span class="elsevierStyleHsp" style=""></span>year&#41; behavioural distraction of the child is required through a variety of methods such as&#58; videos&#59; music&#59; conversation&#59; Valsalva manoeuvres&#59; virtual reality&#59; games&#59; stories&#59; cards&#59; the application of heat and cold&#44; and vibrations&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;11&#44;16&#44;17</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">One of the least studied is the Koala Attachment Distraction &#40;KAD&#41; method&#46; The objectives of this study were therefore to assess and compare the pain and stress of the child &#40;3 to 4 years&#41; in venipuncture between the Koala Attachment Distraction &#40;KAD&#41; method and the physical restraint method&#46; Also&#44; to evaluate the level of anxiety perceived by the companions in both groups&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Methods</span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Study design</span><p id="par0065" class="elsevierStylePara elsevierViewall">Randomised&#44; parallel-group&#44; single-blind clinical trial divided into a control group and an intervention group for the evaluation of pain and stress during venipuncture in paediatric patients and the assessment of anxiety perceived by companions&#46; The study was registered in ClinicalTrials&#46;gov &#40;NCT05453305&#41;&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Participants&#44; 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During the technique&#44; the companion was present and could participate by using consolation or distraction&#44; as usually occurs in the PED&#46; At the same time&#44; a professional from the service was in charge of holding the chosen limb&#44; as well as the opposite one&#46; The nurse in charge performed the venipuncture &#40;for blood extraction and&#47;or placement of a peripheral vascular catheter&#41; while another colleague helped with holding and&#47;or collecting samples&#46; A trained nurse assessed the child&#8217;s pain and stress before and during the procedure&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The patients in the ING clinic sat with their companion on a chair&#44; with the child on top facing the companion&#44; with one leg on each side and the arms resting on the companion&#8217;s shoulders&#46; The patient&#39;s head rested on the adult&#39;s shoulder&#44; contralateral to the limb to be punctured&#46; At the same time&#44; the responsible adult held the patient in a hug-like manner&#46; A professional was in charge of immobilising the limb chosen for puncture&#46; The nurse in charge performed the venipuncture &#40;for blood extraction and&#47;or placement of a peripheral vascular catheter&#41; while another professional assisted with the holding and&#47;or sample collection tasks &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; A trained nurse assessed the child&#39;s pain and stress before and during the procedure&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Outcome variables</span><p id="par0090" class="elsevierStylePara elsevierViewall">When study participants were included&#44; the following variables were recorded for the paediatric participant for both study groups &#40;COG and ING&#41;&#58; age and sex&#44; pain before venipuncture&#44; pain during venipuncture&#59; using the Face&#44; Leg&#44; Activity&#44; Cry&#44; Consolability &#40;FLACC&#41; pain assessment scale&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> The FLACC scale assesses pain through manifestations of facial expressions&#44; leg movement&#44; activity&#44; crying and whether the patient can be consoled&#46; Each of these categories is assessed on a score range of 0&#44; 1 and 2&#46; The total sum is the result of pain from 0 to 10 points&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Paediatric stress was assessed before venipuncture and during venipuncture using the Groningen distress scale<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> for the assessment&#46; The Groningen distress scale assesses paediatric stress in 5 categories &#40;calm without crying&#44; tension without crying&#44; tension and crying&#44; tension and continuous crying&#44; agitation&#44; shouting and physical resistance&#41;&#46; The overall result is a stress range between one and five&#46; The type of venipuncture performed was also recorded&#58; peripheral intravenous cannulation or blood test extraction&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Regarding the parents&#44; the variables of sex&#44; age and number of children were recorded&#46; At the same time&#44; the anxiety perceived by the companions was assessed by giving them the State&#47;Trait Anxiety Questionnaire &#40;STAI&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> so that they could complete it with their perceived sensations before and during the technique&#46; This questionnaire assesses anxiety at a specific moment through twenty questions with Likert-type answers &#40;0&#8211;3&#41;&#46; The higher the score obtained as a result&#44; the higher the level of perceived anxiety&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The entire nursing team of the PED at the Miguel Servet University Hospital in Zaragoza received 4 training sessions regarding the use and application of the pain assessment scales&#44; child stress&#44; and anxiety perceived by companion tools&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Randomisation and masking</span><p id="par0110" class="elsevierStylePara elsevierViewall">Simple randomisation was performed at a 1&#58;1 ratio by consecutive sampling&#44; respecting the balance between both study groups &#40;intervention group and control group&#41; at a proportion level of 50&#37;&#46; Randomisation was performed by an independent evaluator&#44; with no other involvement in the trial&#44; using a computerised randomisation system &#40;Working in Epidemiology&#58; <a href="http://www.winepi.net/">http&#58;&#47;&#47;www&#46;winepi&#46;net&#47;</a>&#41;&#46; Allocation concealment was guaranteed by means of sealed&#44; opaque&#44; sequentially numbered envelopes&#46; When the participating patient agreed to be included in the study&#44; the envelope was opened and the patient was assigned to either the control or intervention group&#46; Due to the nature of the intervention&#44; the participating patients were not blinded to the intervention&#46; To minimize bias between groups&#44; a prior assessment of pain&#44; stress of the child and anxiety perceived by the companions was performed&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">The person in charge of statistical analysis performed the analysis with coded variables without knowing whether the participants had been allocated to the COG or ING&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Statistical methods</span><p id="par0120" class="elsevierStylePara elsevierViewall">Data analysis was performed using the Jamovi&#174; 2&#46;2&#46;2 statistical calculation programme&#46; Due to the difficulty in recruiting for the study&#44; an interim analysis was performed following Pocock&#8217;s and O&#8217;Brien&#8217;s rules and adjusting the level of statistical significance &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>&#46;02&#41;&#46; The descriptive analysis of the data for qualitative variables was presented by the frequency distribution of the percentages for each category&#46; The quantitative variables studied have been explored by the goodness-of-fit test for a normal distribution &#40;Kolmogorov-Smirnov test&#41; and indicators of central tendency &#40;mean or median&#41; and dispersion &#40;standard deviation or interquartile range&#41; are given&#46; The association between quantitative and qualitative variables was studied by means of hypothesis contrast tests with comparison of means &#40;Mann-Whitney U test and Kruskall-Wallis test&#41;&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">For the paired sample association&#44; the Wilcoxon W test was used and for the bivariate correlations&#44; the Spearman correlation coefficient&#46; The relationship of each variable&#44; controlling the possible effect of third variables&#44; was completed&#44; for each study group&#44; by means of the linear regression model&#46; All effects were considered significant if p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>&#46;02&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Ethical aspects</span><p id="par0130" class="elsevierStylePara elsevierViewall">Regarding the ethics of the participation process&#44; after a written and verbal description of all the information related to the study and its objectives &#40;Participant Information Sheet&#41; to the parents&#47;mothers&#47;companions&#44; those who agreed to participate signed the informed consent&#46; The inclusion of participants in the database was anonymous and confidential&#46; During the study&#44; national and international guidelines were followed &#40;code of ethics&#44; Declaration of Helsinki&#41;&#46; Likewise&#44; the humanisation of care was promoted&#44; complying with the European Charter for Hospitalised Children&#44; approved by the European Parliament in 1986&#44; which regulates the right of children to be accompanied&#46; The study was approved by the Ethics and Research Committee of the Autonomous Community of Aragon &#40;PI21&#47;218&#41;&#46;</p></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Results</span><p id="par0135" class="elsevierStylePara elsevierViewall">Four hundred and fifty children were evaluated for participation from June 1&#44; 2021 to May 31&#44; 2022&#44; of which 113 met the inclusion criteria&#46; The final participation was 110 participants &#40;3 of them were excluded for not having completed the STAI scale&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; The participants were homogeneously and randomly distributed in the COG &#40;55&#41; and in the ING &#40;55&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0140" class="elsevierStylePara elsevierViewall">The mean age of the 110 participants was 3&#46;83<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>&#46;587 &#91;95&#37; CI&#58; 3&#46;72&#8211;3&#46;94&#93; and that of their companions was 37&#46;17<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>6&#46;957 &#91;95&#37; CI&#58; 35&#46;87&#8211;38&#46;47&#93;&#46; Fifty per cent of the participants were girls&#46; Regarding the family unit&#44; the mean number of children per family was 1&#46;88<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>&#46;854 &#91;95&#37; CI&#58; 1&#46;72&#8211;2&#46;04&#93;&#46; According to the family members&#8217; accompaniment&#44; 23&#46;6&#37; of the children who went to the emergency department did so with the father&#44; 74&#46;5&#37; with the mother&#44; and 1&#46;8&#37; of them with other companions&#46; According to the registered technique&#44; 20&#46;9&#37; of the children underwent blood tests and 79&#46;1&#37; underwent peripheral intravenous cannulation&#46; Regarding the sociodemographic variables&#44; no statistically significant differences were found between COG and ING in the age of the child &#40;3&#46;84<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>&#46;59 &#91;95&#37; CI&#58; 3&#46;68&#8211;3&#46;99&#93; vs&#46; 3&#46;82<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>&#46;59 &#91;95&#37; CI&#58; 3&#46;66&#8211;3&#46;98&#93;&#41;&#44; in sex &#91;boy&#58; 27&#46;27&#37; &#40;30&#41; vs&#46; 22&#46;73&#37; &#40;25&#41;&#59; girl&#58; 22&#46;73&#37; &#40;25&#41; vs&#46; 27&#46;27&#37; &#40;30&#41;&#59; &#967;<span class="elsevierStyleSup">2</span>&#58;&#46;91&#44; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;34&#93;&#44; in the age of the companions &#40;36&#46;83<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;20 &#91;95&#37; CI&#58; 34&#46;89&#8211;38&#46;78&#93; vs&#46; 37&#46;50<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>6&#46;75 &#91;95&#37; CI&#58; 35&#46;68&#8211;39&#46;33&#93;&#41; and the number of children per family &#40;1&#46;82<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>&#46;72 &#91;95&#37; CI&#58; 1&#46;62&#8211;2&#46;01&#93; vs&#46; 1&#46;95<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>&#46;97 &#91;95&#37; CI&#58; 1&#46;68&#8211;2&#46;21&#93;&#41;&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">In relation to the general study sample&#44; the mean pain rating of the child before venipuncture was 1&#46;70<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2&#46;775 &#91;95&#37; CI&#58; 1&#46;18&#8211;2&#46;22&#93;&#44; and during venipuncture it was 4&#46;75<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;271 &#91;95&#37; CI&#58; 4&#46;14&#8211;5&#46;37&#93; &#40;Wilcoxon W&#58; 210&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001&#41;&#46; The mean stress value of the child before the technique was 1&#46;63<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;074 &#91;95&#37; CI&#58; 1&#46;43&#8211;1&#46;83&#93; and during venipuncture it was 2&#46;96<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;263 &#91;95&#37; CI&#58; 2&#46;73&#8211;3&#46;20&#93; &#40;Wilcoxon W&#58; 109&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001&#41;&#46; Regarding the assessment of anxiety perceived by parents before and during venipuncture&#44; the mean was 24&#46;32<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>13&#46;427 &#91;95&#37; CI&#58; 21&#46;81&#8211;26&#46;83&#93; and 24&#46;02<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>12&#46;853 &#91;95&#37; CI&#58; 21&#46;62&#8211;26&#46;42&#93;&#44; respectively &#40;Wilcoxon W&#58; 2448&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;666&#41;&#46; No statistically significant differences were found between the assessment of pain and stress according to sex or venipuncture technique&#46; Regarding the assessment of pain&#44; stress and anxiety perceived by companions before venipuncture&#44; no statistically significant differences were found between the GCO and the GIN &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0150" class="elsevierStylePara elsevierViewall">In the assessment of pain&#44; stress and anxiety perceived by companions during venipuncture between the COG and the ING&#44; statistically significant differences were found between pain and stress&#46; Regarding the sample size and power for comparison of independent means&#44; with pain being the variable of study&#44; the statistical power was 83&#46;6&#37; &#40;CI 95&#37;&#41;&#46; However&#44; no statistically significant differences were found in the assessment of anxiety perceived by companions between the COG and the ING &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">Strong correlations were found between pain and stress before and during venipuncture in the COG &#40;Spearman&#58; &#46;892&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001 and Spearman&#58; &#46;898&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001&#44; respectively&#41; and a moderate correlation between pre-venipuncture stress and pain during venipuncture &#40;Spearman&#58; &#46;599&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001&#41;&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Strong correlations were found between pain and stress before venipuncture in the ING &#40;Spearman&#58; &#46;802&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001&#41; and during venipuncture &#40;Spearman&#58; &#46;857&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001&#41;&#46; Moderate correlations between prior stress and pain during venipuncture &#40;Spearman&#58; &#46;451&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#60;&#46;001&#41;&#44; between prior anxiety and pain during venipuncture &#40;Spearman&#58; &#46;330&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;014&#41;&#44; between pain and anxiety during the procedure &#40;Spearman&#58; &#46;428&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;001&#41; and between stress and anxiety during the procedure &#40;Spearman&#58; &#46;423&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;001&#41;&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">The prediction of pain during the KAD intervention based on the anxiety of the companion and the stress of the child during the technique suggests an association r<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;839&#46; When extrapolated to the general population matching the same inclusion criteria&#44; 70&#46;4&#37; would behave according to our model &#40;DurFLACC<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;1&#46;7838<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#46;0226&#42;DurSTAI and DurFLACC<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;1&#46;7838<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>1&#46;9229&#42;DurGron&#41;&#46; In the case of the COG technique&#44; the expected pain during it has an even more perfect association r<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;911&#44; so that a percentage of 83&#46;1&#37; would behave as expected &#40;DurFLACC<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;2&#46;6825<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#46;0115&#42;DurSTAI and DurFLACC<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;2&#46;6825<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>2&#46;4672&#42;DurGron&#41;&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discussion</span><p id="par0170" class="elsevierStylePara elsevierViewall">This study assesses and compares pain and stress in children during venipuncture using the KAD method and the physical restraint method&#44; as well as the anxiety perceived by those accompanying them in the PED&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">Pain in children continues to be poorly assessed and treated&#44; especially during the techniques that cause the most pain&#44; such as procedures with needles&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#44;22&#8211;24</span></a></p><p id="par0180" class="elsevierStylePara elsevierViewall">The results of this study show that patients undergoing venipuncture using the KAD method have a significantly lower level of pain than those who received physical restraint&#46; Multiple studies that assess pain during venipuncture exist&#44; using both the Wong-Baker Face Scale and the FLACC scale&#44; showing that the use of different distraction techniques is more effective in reducing pain than the usual restraint methods&#46; The study by Balliel<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> measured pain using the Wong-Baker Face Scale&#44; obtaining less pain in the intervention group &#40;playing with bubbles&#41; than in the control group &#40;in which no distraction measurement was performed&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> The findings of Suleman et al&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> concluded that pain&#44; also assessed with the Wong-Baker Face Scale&#44; decreases significantly when using distraction with colouring pictures&#44; compared to inflating balloons or forcing a cough&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> The study carried out by Lee et al&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a> assesses pain using the FLACC scale and comparing virtual reality with routine venipuncture on a bed&#44; without obtaining significant results&#44; but with a lower average pain in the intervention group&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a></p><p id="par0185" class="elsevierStylePara elsevierViewall">This study shows that venipuncture using the KAD method generates a significantly lower level of stress than those who receive physical restraint&#46; Regarding the above&#44; the study by Dumoulin et al&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> on the pain-stress cycle&#44; which relates the perception of pain with the increase in stress&#44; agrees with the conclusions obtained in this present clinical trial&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0190" class="elsevierStylePara elsevierViewall">It is important to distinguish stress from anxiety&#58; stress is considered to be the physiological reaction to a dangerous situation&#44; while anxiety is an emotional response without the need for a specific stimulus&#46; However&#44; in numerous studies on venipuncture in paediatrics&#44; both terms are used interchangeably&#44; as well as different scales&#46; Ankan et al&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a> compared active distraction with passive distraction and no distraction&#44; using the Children&#8217;s Fear Scale &#40;CFS&#41; to assess children&#8217;s anxiety&#44; obtaining significant differences during venipuncture between the groups&#44; which matches our results&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a> Osmanlliu et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> used the CFS scale for anxiety and the Procedure Behaviour Check &#40;PBC&#41; for stress&#44; obtaining lower results in both variables in the intervention group&#44; the difference being non-significant&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> The study by Balliel<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> measured anxiety using the CFS scale&#44; obtaining less anxiety in the intervention group than in the control group&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0195" class="elsevierStylePara elsevierViewall">The application of non-pharmacological measures &#40;music therapy&#44; contact with parents&#44; Buzzy&#174; vibration and local cold devices&#44; videos or toys&#41; to reduce pain and stress is scarce because it is not standardised&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;4&#44;11&#44;17</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">19&#44;26&#8211;29</span></a> All of them reduce the patient&#8217;s pain by modifying the focus of attention according to The Gate Control Theory of Pain&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">27</span></a> Among the non-pharmacological measures&#44; the most frequent distraction method is the electronic device&#44;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> used in numerous studies&#44; such as the one cobnducted by Lee et al&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a> or Osmanlliu et al&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> Another non-pharmacological measure is the child being in contact with and held by someone in their environment&#44; which is why the KAD method reduces their stress and pain levels&#46; In the study by Trottier et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">30</span></a> 60&#37; of the hospitals surveyed offered the possibility of venipuncture in children held by their parents&#46; Furthermore&#44; 33&#37; of hospitals that did not offer it were considering including it in their unit&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">30</span></a></p><p id="par0200" class="elsevierStylePara elsevierViewall">Pharmacological pain management using topical anaesthetics is of little applicability&#44; despite being strongly recommended&#44; as it requires a long action time to be effective&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> Therefore&#44; the inclusion of non-pharmacological methods of pain relief prior to invasive techniques is essential&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Currently&#44; Ballard et al&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">24</span></a> are conducting a non-inferiority clinical trial comparing the Buzzy&#174; device with the local application of 4&#37; lidocaine&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">24</span></a></p><p id="par0205" class="elsevierStylePara elsevierViewall">With regard to companions&#44; this study shows that anxiety prior to the technique is similar in both groups&#44; while during venipuncture it is higher in the group subjected to physical restraint&#46; In the study by Hartling et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> the usual non-pharmacological measures during venipuncture were compared with music therapy&#44; finding no statistically significant differences in parental anxiety&#46; Other more recent studies such as that by Garc&#237;a-Aracil et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> relate the increase in parental anxiety with the increase in the child&#8217;s stress&#46; When comparing the distraction group with the control group and another distraction group with Buzzy&#174; with the control group&#44; statistically significant differences were found in the assessment of the parents&#8217; anxiety &#40;using the STAI questionnaire&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> In the KAD group&#44; the anxiety perceived by the companions is directly related to the pain and stress perceived by the child&#44; while in the control group there is no relationship between these variables&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">Two main limitations were detected in this study&#46; The first limitation was the high rate of participation losses due to multifactorial causes and having to adjust the degree of statistical significance&#46; The second limitation of this study is the specificity of the selected age group&#46; The assessment carried out in various clinical conditions could also influence the interpretation of pain&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">Venipuncture in the PED using the KAD method has been shown to be effective in managing pain and stress in children during the technique in paediatric patients between 3 and 4 years of age&#46; Its introduction into the protocols of our unit is therefore recommended&#44; as well as in the PEDs of other third-level hospitals with a similar context&#46;</p><p id="par0220" class="elsevierStylePara elsevierViewall">Two future lines of research are proposed&#46; Firstly&#44; the examination and approach to the anxiety felt by the companion when faced with stressful and painful procedures to the child in an emergency situation&#46; Secondly&#44; the application of the KAD method in a wider age range so that more paediatric patients benefit from this intervention aimed at reducing their pain and stress during an invasive process&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Funding</span><p id="par0225" class="elsevierStylePara elsevierViewall">This study received no funding&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Conflict of interest</span><p id="par0230" class="elsevierStylePara elsevierViewall">The authors have no conflict of interests to declare&#46;</p></span></span>"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">To assess&#44; compare and relate the toddler&#8217;s pain and anxiety during venipuncture by using either the Koala Attachment Distraction method or the physical restraint method and to evaluate the level of anxiety perceived by the companions in both groups&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Method</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Randomised&#44; single-blind&#44; controlled clinical trial in two arms &#40;control and intervention group&#41; conducted in the paediatric emergency department of a tertiary university hospital&#46; The study variables were pain and stress of the child and anxiety perceived by the accompanying persons in both groups at the time before and during the technique&#46; The pain rating scale Face&#44; Leg&#44; Activity&#44; Cry&#44; Consolability&#59; the Groningen stress scale and the STAI questionnaire were used&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">A total of 113 participants aged 3 to 4 years participated in the trial &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>113&#41;&#46; 50&#37; &#40;55&#41; were girls&#44; mean total age 3&#46;83<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;59 years and accompanying persons 37&#46;17<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>6&#46;96&#46; During the technique the mean pain in control and intervention groups was 5&#46;64<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;30 and 3&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;01&#59; stress&#44; 3&#46;25<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;22 and 2&#46;67<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;24&#44; respectively&#46; No statistically significant differences were found in the assessment of anxiety between the groups&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Patients who underwent the Koala Attachment Distraction method venipuncture show a lower level of pain and anxiety than those who received physical restraint&#44; and the anxiety perceived by the companion is similar in both groups&#46;</p></span>"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Valorar&#44; comparar y relacionar el dolor y estr&#233;s del ni&#241;o en la venopunci&#243;n mediante el m&#233;todo Distracci&#243;n con Apego Koala y m&#233;todo de contenci&#243;n f&#237;sica y evaluar el nivel de ansiedad percibido por los acompa&#241;antes en ambos grupos&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todo</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Ensayo cl&#237;nico aleatorio simple ciego controlado en dos brazos &#40;grupo control e intervenci&#243;n&#41; realizado en el servicio de urgencias pedi&#225;tricas de un hospital universitario de tercer nivel&#46; Las variables de estudio fueron dolor y estr&#233;s del ni&#241;o y ansiedad percibida por los acompa&#241;antes en ambos grupos en el momento previo y durante la t&#233;cnica&#46; Se us&#243; la escala de valoraci&#243;n del dolor Face&#44; Leg&#44; Activity&#44; Cry&#44; Consolability&#59; la escala de estr&#233;s de Groningen y el cuestionario STAI&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Un total de 113 participantes entre 3 y 4 a&#241;os participaron en el ensayo &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>113&#41;&#46; El 50&#37; &#40;55&#41; fueron ni&#241;as&#44; media de edad total 3&#46;83<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;59 a&#241;os y acompa&#241;antes 37&#46;17<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>6&#46;96&#46; Durante la t&#233;cnica la media de dolor en grupo control e intervenci&#243;n fue de 5&#46;64<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;30 y 3&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;01&#59; de estr&#233;s&#44; 3&#46;25<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;22 y 2&#46;67<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;24&#44; respectivamente&#46; No se hallaron diferencias estad&#237;sticamente significativas en la valoraci&#243;n de la ansiedad entre los grupos&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Los pacientes sometidos a venopunci&#243;n mediante el m&#233;todo Distracci&#243;n con Apego Koala presentan un nivel de dolor y estr&#233;s inferior a aquellos que recibieron contenci&#243;n f&#237;sica y la ansiedad percibida por el acompa&#241;ante es similar en ambos grupos&#46;</p></span>"
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                  \t\t\t\t">0 &#40;2&#46;00&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">PreGroningen</td><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&#91;95&#37; CI&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;67<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;00&#91;1&#46;40&#8211;1&#46;94&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;58<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;15&#91;1&#46;27&#8211;1&#46;89&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;66</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#8722;&#46;36</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;53</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#40;1&#46;00&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 &#40;&#46;00&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">DurSTAI</td><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&#91;95&#37; CI&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">25&#46;11<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>12&#46;61&#91;21&#46;77&#8211;28&#46;44&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">22&#46;93<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>13&#46;11&#91;19&#46;46&#8211;26&#46;39&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;38</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#8722;&#46;27</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;61</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Median &#40;RIC&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">24 &#40;18&#46;00&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">22 &#40;16&#46;50&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">DurFLACC</td><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&#91;95&#37; CI&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">5&#46;64<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;30&#91;4&#46;76&#8211;6&#46;51&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&#46;87<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>3&#46;01&#91;3&#46;07&#8211;4&#46;67&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;004</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;09</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">1&#46;01</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 &#40;5&#46;50&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 &#40;4&#46;00&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead rowgroup " rowspan="2" align="left" valign="middle">DurGroningen</td><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>SD&#91;95&#37; CI&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&#46;25<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;22&#91;2&#46;93&#8211;3&#46;58&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&#46;67<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;24&#91;2&#46;34&#8211;3&#46;00&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;015</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;01</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " rowspan="2" align="left" valign="middle">&#46;93</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Median &#40;IQR&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 &#40;1&#46;00&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 &#40;2&#46;50&#41;&nbsp;\t\t\t\t\t\t\n
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        "descripcion" => array:1 [
          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Analysis of the study variables distributed by the COG &#40;control group&#41; and the ING &#40;intervention group&#41;&#46;</p>"
        ]
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        "identificador" => "tb0005"
        "tipo" => "MULTIMEDIATEXTO"
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        "texto" => array:1 [
          "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">What is known</span><p id="par0005" class="elsevierStylePara elsevierViewall">Venipuncture is one of the techniques that causes the most pain in children&#46; Evidence shows that pain is related to stress&#46; The experience perceived by children when faced with pain can emotionally influence parents&#44; causing anxiety&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">What it contributes</span><p id="par0010" class="elsevierStylePara elsevierViewall">The Koala Attachment Distraction method is effective in reducing pain and stress in children undergoing venipuncture in emergency services&#46; It is also useful in reducing the anxiety of those accompanying them during venipuncture&#46;</p></span></span>"
        ]
      ]
    ]
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      "titulo" => "References"
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                    0 => array:2 [
                      "titulo" => "An evidence-based approach to minimizing acute procedural pain in the emergency department and beyond"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "S&#46; Ali"
                            1 => "T&#46; McGrath"
                            2 => "A&#46;L&#46; Drendel"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1097/PEC.0000000000000669"
                      "Revista" => array:6 [
                        "tituloSerie" => "Pediatr Emerg Care"
                        "fecha" => "2016"
                        "volumen" => "32"
                        "paginaInicial" => "36"
                        "paginaFinal" => "42"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26720064"
                            "web" => "Medline"
                          ]
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                      ]
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              "identificador" => "bib0010"
              "etiqueta" => "2"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "A randomized controlled trial of the use of virtual reality for needle-related procedures in children and adolescents in the emergency department"
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                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "S&#46; Dumoulin"
                            1 => "S&#46; Bouchard"
                            2 => "J&#46; Ellis"
                            3 => "K&#46;L&#46; Lavoie"
                            4 => "M&#46;P&#46; V&#233;zina"
                            5 => "P&#46; Charbonneau"
                          ]
                        ]
                      ]
                    ]
                  ]
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                    0 => array:2 [
                      "doi" => "10.1089/g4h.2018.0111"
                      "Revista" => array:6 [
                        "tituloSerie" => "Games Health J"
                        "fecha" => "2019"
                        "volumen" => "8"
                        "paginaInicial" => "285"
                        "paginaFinal" => "293"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/31135178"
                            "web" => "Medline"
                          ]
                        ]
                      ]
                    ]
                  ]
                ]
              ]
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              "identificador" => "bib0015"
              "etiqueta" => "3"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Procedural pain in children&#58; a qualitative study of caregiver experiences and information needs"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:4 [
                            0 => "K&#46; Shave"
                            1 => "S&#46; Ali"
                            2 => "S&#46;D&#46; Scott"
                            3 => "L&#46; Hartling"
                          ]
                        ]
                      ]
                    ]
                  ]
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                    0 => array:2 [
                      "doi" => "10.1186/s12887-018-1300-y"
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                        "tituloSerie" => "BMC Pediatr"
                        "fecha" => "2018"
                        "volumen" => "18"
                        "paginaInicial" => "324"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/30316301"
                            "web" => "Medline"
                          ]
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                ]
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              "etiqueta" => "4"
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                    0 => array:2 [
                      "titulo" => "The association of children&#8217;s distress during venepuncture with parent and staff behaviours"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:5 [
                            0 => "S&#46; Thompson"
                            1 => "S&#46; Ayers"
                            2 => "C&#46; Pervilhac"
                            3 => "L&#46; Mahoney"
                            4 => "P&#46; Seddon"
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                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1177/1367493515598643"
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                        "tituloSerie" => "J Child Health Care"
                        "fecha" => "2016"
                        "volumen" => "20"
                        "paginaInicial" => "267"
                        "paginaFinal" => "276"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26316521"
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                      "titulo" => "Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain&#58; a randomized clinical trial"
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                          "etal" => false
                          "autores" => array:6 [
                            0 => "Z&#46; Yu"
                            1 => "Y&#46; Zhou"
                            2 => "X&#46; Xu"
                            3 => "L&#46; Lin"
                            4 => "Q&#46; Le"
                            5 => "Y&#46; Gu"
                          ]
                        ]
                      ]
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                      "doi" => "10.1186/s12887-023-03855-z"
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                      "titulo" => "Individual cartoon video for alleviating perioperative anxiety and reducing emergence delirium in children&#58; a prospective randomised trial"
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                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "X&#46; Tang"
                            1 => "M&#46; Zhang"
                            2 => "L&#46; Yang"
                            3 => "X&#46; Tao"
                            4 => "Y&#46; Li"
                            5 => "Y&#46; Wang"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1136/bmjpo-2023-001854"
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                        "tituloSerie" => "BMJ Paediatr Open"
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                        "volumen" => "7"
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                    0 => array:2 [
                      "titulo" => "Procedural Pain Scale Evaluation &#40;PROPoSE&#41; study&#58; protocol for an evaluation of the psychometric properties of behavioural pain scales for the assessment of procedural pain in infants and children aged 6&#8211;42 months"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:6 [
                            0 => "D&#46;J&#46; Crellin"
                            1 => "D&#46; Harrison"
                            2 => "A&#46; Hutchinson"
                            3 => "T&#46; Schuster"
                            4 => "N&#46; Santamaria"
                            5 => "F&#46;E&#46; Babl"
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                    0 => array:2 [
                      "doi" => "10.1136/BMJOPEN-2017-016225"
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                        "tituloSerie" => "BMJ Open"
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Article information

ISSN: 24451479
Original language: English

DOI:10.1016/j.enfcle.2024.09.007

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