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Nonpharmacological interventions can be further subdivided into support methods &#40;such as viewing videos&#44; reading books and companionship&#41;&#44; cognitive methods &#40;such as relaxation or distraction&#41; and physical methods &#40;positioning&#44; massaging and stimulation of the skin by means of vibrations or the application of heat or cold&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0200"><span class="elsevierStyleSup">1&#44;3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">As regards the cognitive methods&#44; it has been hypothesised that the &#8220;ideal distractor&#8221; is one that draws attention to something that involves the use of several senses &#40;vision&#44; touch&#44; hearing&#41; and has an emotional impact&#44; so that it can compete with the unpleasant stimulus&#46; Few articles in the literature have addressed the use of emerging technologies&#44; such as virtual reality &#40;VR&#41;&#44; for analgesia in the paediatric population during interventions such as burn care&#44; chemotherapy&#44; dental procedures and other medical procedures&#46;<a class="elsevierStyleCrossRefs" href="#bib0215"><span class="elsevierStyleSup">4&#8211;9</span></a> Neurophysiological studies that used functional magnetic resonance imaging have also found that it achieves a reduction in perceived pain&#46;<a class="elsevierStyleCrossRefs" href="#bib0245"><span class="elsevierStyleSup">10&#44;11</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">When it comes to pharmacological methods&#44; the use of topical anaesthetic drugs avoids systemic effects and reduces adverse events&#46; In clinical practice&#44; a cream consisting of a combination of prilocaine and lidocaine &#40;both at 2&#46;5&#37;&#41; is frequently used and has proven effective as an anaesthetic in minor invasive procedures&#46;<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">12&#8211;18</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The aim of the study was to assess whether the use of VR&#44; both in isolation or combined with the use of a lidocaine&#47;prilocaine cream&#44; reduced pain and anxiety during invasive procedures in patients hospitalised in the paediatric ward without producing clinically relevant adverse effects&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study design and sample</span><p id="par0030" class="elsevierStylePara elsevierViewall">We conducted an observational&#44; analytical prospective cohort study in which we included patients aged 4&#8211;15 years admitted to the paediatric ward between November 2016 and June 2018 that needed to undergo an invasive procedure&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Inclusion and exclusion criteria</span><p id="par0035" class="elsevierStylePara elsevierViewall">We included patients aged more than 4 years to be able to use VR and validated scales&#46; We excluded patients who were clinically unstable&#44; received other types of analgesia during the procedure&#44; with cognitive impairments or in whom it was not possible to use the scales&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Since we conducted an observational study&#44; decisions on which methods were to be used for analgesia were made by the provider that ordered the invasive procedure in adherence with the routine clinical protocols of the unit&#46; We considered that allocating patients randomly to a control group would be unethical&#44; since we had available methods for pain relief whose efficacy had already been demonstrated in past research&#46; Thus&#44; the patients that constituted the control group were those who required the interventions in evening and night shifts&#44; as the protocol had not been introduced in those shifts yet&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Materials</span><p id="par0045" class="elsevierStylePara elsevierViewall">We delivered the VR intervention with the Woxter Neo VR1 glasses &#40;adjusting the lenses to match the interpupillary distance&#41; fitted with a mobile device &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>a&#41; and headphones to enhance the immersion in the virtual world &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>b and c&#41;&#46; We allowed patients to choose from a variety of previously reviewed videos based on the age and tastes of the patient&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">Some patients received a prilocaine&#47;lidocaine cream as adjuvant treatment as established in our analgesia protocol&#44; which includes the following recommendations from the manufacturer&#58; apply 1&#8211;2<span class="elsevierStyleHsp" style=""></span>g of cream in the area where numbness may be needed &#40;only on intact skin&#41; over an area not exceeding 10<span class="elsevierStyleHsp" style=""></span>cm<span class="elsevierStyleSup">2</span> and cover with an occlusive dressing&#44; let sit for 60<span class="elsevierStyleHsp" style=""></span>min and puncture the skin within 30<span class="elsevierStyleHsp" style=""></span>min from removing the dressing&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Study variables</span><p id="par0055" class="elsevierStylePara elsevierViewall">We recorded data for the following variables&#58; age&#44; sex&#44; diagnosis&#44; type of procedure&#44; adjuvant use of topical analgesic cream or lack thereof&#44; adverse events&#44; pain and anxiety scale scores self-reported by patients &#40;Wong-Baker FACES pain rating scale &#91;WBS&#93; in patients aged 4&#8211;6 years&#44; rated on a scale of 0&#8211;5&#44;<a class="elsevierStyleCrossRefs" href="#bib0290"><span class="elsevierStyleSup">19&#44;20</span></a> Visual Analogue Scale &#91;VAS&#93; in patients aged more than 7 years&#44; rated on a scale from 0 to 5&#44;<a class="elsevierStyleCrossRefs" href="#bib0290"><span class="elsevierStyleSup">19&#44;21</span></a> and Children&#39;s Fear Scale &#91;CFS&#93;&#44; rated on a scale from 0 to 4&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0200"><span class="elsevierStyleSup">1&#44;22</span></a> We also documented proxy reports of pain and anxiety given by adults that were present during the procedure&#44; including family members and health care staff&#44; who completed the scales independently from the child&#58; numeric rating scale &#40;NRS&#41;&#44; on a scale of 0&#8211;5&#44;<a class="elsevierStyleCrossRefs" href="#bib0290"><span class="elsevierStyleSup">19&#44;23</span></a> and CFS for assessment of anxiety&#44; on a scale of 0&#8211;4&#46; In every pain assessment scale used&#44; 0 stood for the absence of pain and 5 for the most severe pain imaginable&#46; We modified all the scales to have scores ranging from 0 to 5 in order to make the results comparable &#40;<a class="elsevierStyleCrossRef" href="#sec0080">Appendix A</a>&#41;&#46; We also conducted a satisfaction survey&#46; When it came to the use of topical analgesic cream as adjuvant treatment&#44; we documented whether its use conformed to the specifications given in the summary of product characteristics and any adverse events&#44; as well as the methaemoglobin level in patients in whom a blood gas analysis had been performed&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">The study was approved by the Ethics Committee of the hospital &#40;CEIC 295&#47;17&#41;&#46; We informed all patients and their guardians about the study&#44; and obtained their informed consent in writing for participation in the study&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">We performed the statistical analysis with the software SPSS Statistics version 21 &#40;IBM SPSS Statistics&#59; Armonk&#44; NY&#44; USA&#41;&#46; We have summarised qualitative variables data as percentages and quantitative data as median and interquartile range &#40;IQR&#41;&#46; We compared qualitative variables by means of the chi square and Fisher exact tests&#46; We compared continuous quantitative data with the Mann&#8211;Whitney <span class="elsevierStyleItalic">U</span> and Kruskal&#8211;Wallis tests&#46; We assessed the correlation between variables using the Spearman&#39;s correlation coefficient&#46; We performed a multivariate analysis and fitted a linear regression model in which the dependent variable was the pain assessment scale score and the covariates were the age&#44; sex&#44; type of procedure&#44; use of adjuvant interventions and number of punctures performed during the procedure&#46; Statistical significance was defined as a <span class="elsevierStyleItalic">P</span>-value of less than 0&#46;05 in any of the tests&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Sample characteristics</span><p id="par0070" class="elsevierStylePara elsevierViewall">The sample included 58 patients with a median age of 120 months &#40;IQR&#44; 84&#8211;156&#41;&#59; 34 participants &#40;58&#46;2&#37;&#41; were female&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">The most frequent reason for admission was acute gastrointestinal illness followed by acute respiratory illness&#46; As for the type of procedure&#44; most of the patients required extraction of a blood sample &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Effect of virtual reality</span><p id="par0080" class="elsevierStylePara elsevierViewall">Virtual reality was used as a distraction technique in 38 patients &#40;VR group&#41;&#44; and 20 patients in whom no analgesia or distraction techniques were used constituted the control group&#46; Both groups were comparable in terms of the age&#44; sex&#44; number of punctures and types of procedures performed &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0085" class="elsevierStylePara elsevierViewall">When we compared the scores of the assessment scales&#44; we found lower scores for both pain and anxiety as reported by patients&#44; family members and health professionals in the VR group&#44; differences that were statistically significant &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#60;</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>001&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">None of the patients experienced adverse events associated with the use of VR&#46; We found a strong correlation between the pain perceived by patients and the pain reported by family members &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;87&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>01&#41; and the health care staff &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;84&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>01&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>&#41;&#44; as well as a good correlation between the anxiety perceived by patients and the anxiety reported by family members &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;782&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>01&#41; and the health care staff &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;738&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>01&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">The linear regression analysis showed that the number of punctures &#40;<span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;5&#59; <span class="elsevierStyleItalic">&#946;</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;6&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>01&#41; and the lack of use of adjuvant interventions &#40;<span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;5&#59; <span class="elsevierStyleItalic">&#946;</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;0&#46;9&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>02&#41; were associated with higher scores in pain scales in children&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Analysis of the combined use of topical analgesic cream</span><p id="par0100" class="elsevierStylePara elsevierViewall">Topical prilocaine&#47;lidocaine cream was used in combination with VR in 13 patients &#40;VR<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>analgesic cream subgroup&#41;&#44; and we compared this subgroup with the 25 patients in whom VR was used in isolation &#40;VR without cream&#41; and with a control group that was comparable in terms of age&#44; sex&#44; number of punctures and types of procedures &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0105" class="elsevierStylePara elsevierViewall">In comparison with the control group&#44; the scores in the pain and anxiety assessment scales as reported by patients&#44; family members and health care providers were significantly lower in both VR subgroups &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>05&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">When we compared the VR without cream and the VR<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>analgesic cream subgroups&#44; we found lower pain scores in the VR<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>analgesic cream subgroup as reported by the patients &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>02&#41;&#44; the parents &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>03&#41; and the health care staff &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>001&#41;&#46; When it came to the anxiety measures&#44; we only found lower scores in the reports made by health providers &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>03&#41;&#44; and no differences in the reports made by the patients &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>86&#41; or the parents &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>19&#41;&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">None of the patients experienced adverse events or had elevated methaemoglobin levels associated with the use of analgesic cream&#44; and we found no differences in these parameters between groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">The analgesic cream was used as directed in 100&#37; of cases&#44; with the cream being allowed to sit under the dressing for a median of 60<span class="elsevierStyleHsp" style=""></span>min &#40;IQR&#44; 60-60&#41; and performance of the procedure within 2<span class="elsevierStyleHsp" style=""></span>min of its removal &#40;IQR&#44; 2&#8211;5&#41;&#46; We found no correlation between the pain reported by the patient and the duration of exposure to the cream &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;408&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>24&#41; or the time elapsed from removal of the cream to performance of the procedure &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;16&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#46;</span>64&#41;&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Satisfaction survey and characteristics of previous invasive procedures</span><p id="par0125" class="elsevierStylePara elsevierViewall">We conducted a satisfaction survey with participation of 54 patients&#44; 58 family members and 50 health providers&#46; Eighty-five percent of patients had previously required invasive procedures&#44; but only 4&#46;3&#37; reported the use of analgesia during that prior experience&#44; which in all cases consisted on the application of a topical cream&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">In the patient survey&#44; 85&#46;7&#37; reported perceiving less pain than expected with the analgesic methods used&#44; and 63&#46;4&#37;&#44; feeling less anxious&#46; In addition&#44; 95&#46;5&#37; expressed the wish that these techniques be used again should they require additional procedures in the future&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">In the survey of family members&#44; 74&#46;1&#37; reported that they perceived less pain in the patient and 31&#46;5&#37; that they perceived less anxiety&#59; 96&#46;3&#37; requested the use of the same techniques if the patient required procedures in the future&#46; Also&#44; 86&#46;8&#37; believed that the use of these techniques had facilitated performance of the procedure&#44; and 84&#46;6&#37; that they themselves experienced less anxiety during the procedure&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">The survey of health professionals showed that 92&#37; considered that the use of analgesic interventions had facilitated performance of the procedure&#46;</p></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Discussion</span><p id="par0145" class="elsevierStylePara elsevierViewall">The findings of our study suggest that the use of adjuvant interventions during invasive procedures can reduce pain and anxiety in patients hospitalised in the paediatric ward&#44; with results similar to those reported in the previous literature with the use of VR in isolation<a class="elsevierStyleCrossRefs" href="#bib0220"><span class="elsevierStyleSup">5&#8211;9</span></a> or combined with topical analgesic creams&#46;<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">12&#8211;17</span></a></p><p id="par0150" class="elsevierStylePara elsevierViewall">Although most patients in our cohort were previously healthy&#44; a high proportion had needed invasive procedures in the past&#46; Previous studies suggest that the analgesic effect of distraction techniques may be greater in patients with underlying disease&#44;<a class="elsevierStyleCrossRefs" href="#bib0225"><span class="elsevierStyleSup">6&#44;9</span></a> a population in which it is possible to compare the severity of perceived pain with the pain perceived during previous experiences&#44; but in our study we also found evidence of this effect in previously healthy patients admitted to hospital due to acute disease&#46;<a class="elsevierStyleCrossRef" href="#bib0315"><span class="elsevierStyleSup">24</span></a></p><p id="par0155" class="elsevierStylePara elsevierViewall">One of the strengths of our study is that patients were able to choose from several videos that had been previously reviewed&#44; as past evidence suggests that having choices achieves a greater reduction of pain&#46;<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">9</span></a></p><p id="par0160" class="elsevierStylePara elsevierViewall">In most of the previous literature&#44; the pain scales were administered only to the patients&#44; unlike in our study&#44; where we also obtained proxy reports from family members and health care staff&#46; We administered the scales individually and in writing to avoid influencing the responses of participants&#44; and we found a very strong correlation between the self-reports of patients and the assessments of the pain experienced by patients made by family members and the health care staff&#46; The assessment of anxiety in children is an area that still needs further development&#44; as there are no validated scales for measuring anxiety in children aged less than 5 years&#46; In this study we used the CFS in children aged more than 4 years and obtained results that were similar to those reported in the previous literature&#44; where this scale was used in children aged more than 5 years&#46;<a class="elsevierStyleCrossRef" href="#bib0305"><span class="elsevierStyleSup">22</span></a></p><p id="par0165" class="elsevierStylePara elsevierViewall">The findings of our study are consistent with those of other studies that have demonstrated that VR is a nonpharmacological cognitive method that is quite helpful for relief of pain and anxiety&#46; There are previous studies with very different characteristics that support the use of this technique conducted in healthy adults&#44;<a class="elsevierStyleCrossRefs" href="#bib0320"><span class="elsevierStyleSup">25&#44;26</span></a> healthy children exposed to pain through the cold pressor test&#44;<a class="elsevierStyleCrossRef" href="#bib0330"><span class="elsevierStyleSup">27</span></a> paediatric cancer patients undergoing phlebotomy procedures&#44;<a class="elsevierStyleCrossRef" href="#bib0225"><span class="elsevierStyleSup">6</span></a> paediatric cancer patients undergoing lumbar puncture&#44;<a class="elsevierStyleCrossRef" href="#bib0230"><span class="elsevierStyleSup">7</span></a> adults and children receiving care for burns&#44;<a class="elsevierStyleCrossRefs" href="#bib0335"><span class="elsevierStyleSup">28&#44;29</span></a> paediatric outpatients undergoing phlebotomy procecures&#44;<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">5</span></a> etc&#46; To our knowledge&#44; ours is the first study conducted in patients hospitalised in a paediatric ward&#44; a subpopulation that has not yet been assessed in the literature that could unquestionably benefit from these modalities of analgesia&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">Some authors assert that the use of active distraction&#44; where the patient is immersed in the film&#44; is more effective compared to passive distraction through videos&#44;<a class="elsevierStyleCrossRef" href="#bib0345"><span class="elsevierStyleSup">30</span></a> a hypothesis supported by our findings&#44; and the isolation created by the glasses and headphones facilitates detachment from the unpleasant situation to which the patient is exposed&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">None of the patients experienced adverse events associated with the use of VR&#44; which may include nausea&#44; dizziness or other motion sickness symptoms described in previous studies&#46;<a class="elsevierStyleCrossRef" href="#bib0350"><span class="elsevierStyleSup">31</span></a> This aspect may be associated with the choice of VR device&#46; We ought to highlight the differences between VR glasses used in combination with mobile devices&#44; which are safe to use from age 4 to 5 years if they allow adjustment of the interpupillary distance&#44; and standalone headsets &#40;with a 3D screen&#41; designed for gaming&#44; which are not recommended for children aged less than 12 years since they are the interface that usually produces the aforementioned side effects&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">There is controversy in the literature regarding the use of analgesic creams in invasive procedures&#44; although most of the research has assessed their use in isolation&#46;<a class="elsevierStyleCrossRefs" href="#bib0355"><span class="elsevierStyleSup">32&#44;33</span></a>&#46; When it comes to analgesic creams as adjuvant treatment&#44; as was the case in our study&#44; most studies support their use&#46;<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">12&#8211;17</span></a> Some studies have not found any benefit from their use&#44; which could be due to the simultaneous use of distraction&#44; which may mask the effects of creams&#46;<a class="elsevierStyleCrossRef" href="#bib0365"><span class="elsevierStyleSup">34</span></a> Our study found an increase in pain relief when cream was used in combination with VR&#44; although it did not add to the anxiety-reducing effect of VR&#46; Although some authors have reported adverse events associated with the use of topical creams &#40;methaemoglobinaemia&#44; seizures&#44; vasoconstriction and contact dermatitis&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0285"><span class="elsevierStyleSup">18</span></a> we had no such case in our sample&#46; This is probably due to the fact that the directions for the use of this drug were always adhered to&#44; in contrast to some of the cases described in the literature in which topical creams were used inappropriately&#44; for instance&#44; by applying them to a large surface or on broken skin&#46;<a class="elsevierStyleCrossRefs" href="#bib0370"><span class="elsevierStyleSup">35&#8211;37</span></a> Some authors have reported that these creams may cause vasoconstriction&#44; which can be counteracted with the application of heat&#44;<a class="elsevierStyleCrossRef" href="#bib0385"><span class="elsevierStyleSup">38</span></a> while others state that their application does not interfere with the performance of the procedure&#46;<a class="elsevierStyleCrossRef" href="#bib0390"><span class="elsevierStyleSup">39</span></a> Our data support the latter view&#44; as we did not find any differences between the groups in the number of punctures&#44; a variable whose increase may indicate increased difficulty in performing a procedure&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">We found a high degree of satisfaction in the patients and their family members in relation to the use of VR&#44; as they considered that in addition to alleviating pain and anxiety&#44; it facilitated the performance of the procedure and also reduced the anxiety of the accompanying person&#46; Most patients and their families requested the use of VR if they happened to need further procedures in the future&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">As for the limitations of this study&#44; the chief one is its observational design&#44; as patients were not randomised to different groups&#44; although comparing the baseline characteristics of patients in each group we found that the 2 groups were comparable&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">Another limitation is the low number of patients in the sample that underwent other interventions commonly performed during hospitalization&#44; such as lumbar puncture&#46; This is due to the fact that since these interventions are known to be more painful in and of themselves&#44; their performance involved the use of drugs or other analgesic measures that resulted in the exclusion of these patients from the study&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">Last of all&#44; it is important to highlight that the main outcome variables in our study were clinical scales that cannot but be somewhat subjective&#44; although the use of other parameters&#44; such as blood pressure and heart rate&#44; complicated their interpretation&#44; as the patients in the study had acute illness and could have fever or breathing difficulties at the time the procedure was performed&#44; which was a potential a source of bias&#46; To minimise the impact of this limitation&#44; we used these instruments to assess the perception of not only the patients&#44; but also the family members and the health care staff&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">We expect that future performance of randomised clinical trials in paediatric patient comparing the use of VR and other interventions such as analgesic cream alone or the application of cold&#44; heat or vibration during painful procedures will provide us with more rigorous evidence on these techniques&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Comments</span><p id="par0210" class="elsevierStylePara elsevierViewall">The use of VR during invasive procedures in patients hospitalised in the paediatric ward reduced the pain and anxiety perceived by the patient&#44; families and health care staff&#46; We found that pain scores increased as the number of punctures used in a procedure increased and decreased with the use of adjuvant interventions&#46; We did not identify any adverse events associated to the use of VR or analgesic cream or any data suggesting that they interfered with performance of the procedure&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">Patients and their families expressed a high level of satisfaction in relation to the use of VR&#44; as they found that in addition to reducing pain and anxiety&#44; it facilitated performance of the procedure and also reduced the anxiety of the accompanying person&#44; and stated they would request the use of VR should they need additional procedures in the future&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conflicts of interest</span><p id="par0220" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare</p></span></span>"
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            0 => "Realidad virtual"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Potentially painful invasive procedures are often performed for diagnostic or therapeutic purposes in hospitalised paediatric patients&#46; Approaches&#44; such as virtual reality &#40;VR&#41;&#44; should be sought in order to minimise pain and anxiety during these procedures&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Materials and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Hospitalised patients between 4 and 15-years-old requiring an invasive procedure were included&#46; Pain and anxiety evaluation scales were given to children&#44; relatives and health workers&#46; A comparison was made with patients in whom VR was used &#40;with or without concomitant use of a prilocaine&#47;lidocaine 2&#46;5&#37; analgesic cream&#41; and patients in whom neither VR nor analgesic cream were used&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The study included 58 patients&#44; 38 in the VR group and 20 in the control group&#46; Pain scores&#44; as performed by patients&#44; relatives and health workers&#44; significantly decreased in the VR group &#40;control group median 4&#47;5 vs&#46; VR group median 1&#47;5&#44; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>&#46;001&#41;&#46; Patient-reported anxiety scales were also lower in the VR group &#40;control group median 4&#47;5 vs&#46; VR group 1&#47;5&#44; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;001&#41;&#46; The number of punctures &#40;<span class="elsevierStyleItalic">R</span><span class="elsevierStyleSup">2</span>&#58; 0&#46;5&#44; <span class="elsevierStyleItalic">&#946;</span>&#58; 0&#46;6&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;01&#41; and the lack of analgesic techniques &#40;<span class="elsevierStyleItalic">&#946;</span>&#58; &#8722;0&#46;9&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;02&#41; were associated with higher scores in patient-reported pain scales&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Comments</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The use of VR can reduce pain and anxiety during invasive procedures in hospitalized children&#46;</p></span>"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La realizaci&#243;n de procedimientos invasivos dolorosos con fines terap&#233;uticos o diagn&#243;sticos en pacientes pedi&#225;tricos hospitalizados es frecuente en la pr&#225;ctica diaria&#46; Se deben buscar estrategias encaminadas a disminuir el dolor y la ansiedad durante estas t&#233;cnicas&#44; como el uso de realidad virtual &#40;RV&#41;&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Materiales y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se realiz&#243; un estudio observacional&#44; anal&#237;tico y prospectivo&#44; en el cual se incluyeron todos los pacientes pedi&#225;tricos hospitalizados de entre 4 y 15 a&#241;os que precisaron procedimientos invasivos&#46; Se recogieron escalas de valoraci&#243;n de dolor y ansiedad a los pacientes &#40;ajustadas a su edad&#41;&#44; familiares y personal sanitario y se compar&#243; el uso de la RV&#44; de manera aislada y asociado a una crema anest&#233;sica &#40;priloca&#237;na&#47;lidoca&#237;na crema 2&#44;5&#37;&#41;&#44; con un grupo control en el que no se utiliz&#243; ninguna t&#233;cnica analg&#233;sica&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 58 pacientes&#44; de los cuales 38 usaron la RV &#40;grupo RV&#41; y 20 pacientes no recibieron ninguna t&#233;cnica analg&#233;sica ni de distracci&#243;n &#40;grupo control&#41;&#46; El uso de RV disminuy&#243; las puntuaciones en la mediana de las escalas de dolor en ni&#241;os&#44; familiares y personal sanitario &#40;grupo control 4&#47;5 vs&#46; grupo RV 1&#47;5&#44; p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#44; y en las escalas de ansiedad en ni&#241;os &#40;grupo control 4&#47;5 vs&#46; grupo RV 1&#47;5&#44; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46; En el an&#225;lisis multivariante&#44; el n&#250;mero de punciones &#40;R<span class="elsevierStyleSup">2</span>&#58; 0&#44;5&#59; &#946;&#58; 0&#44;6&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;01&#41; y la ausencia de t&#233;cnicas coadyuvantes &#40;&#946;&#58; &#8722;0&#44;9&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;02&#41; se asociaron con puntuaciones m&#225;s elevadas en la escala del dolor en ni&#241;os&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Comentarios</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">El empleo de RV disminuye el dolor y la ansiedad durante la realizaci&#243;n de procedimientos invasivos en pacientes pedi&#225;tricos hospitalizados&#46;</p></span>"
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        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0015">Please cite this article as&#58; Toledo del Castillo B&#44; P&#233;rez Torres JA&#44; Morente S&#225;nchez L&#44; Escobar Castellanos M&#44; Escobar Fern&#225;ndez L&#44; Gonz&#225;lez S&#225;nchez MI&#44; et al&#46; Disminuyendo el dolor en los procedimientos invasivos durante la hospitalizaci&#243;n pedi&#225;trica&#58; &#191;ficci&#243;n&#44; realidad o realidad virtual&#63;&#46; An Pediatr &#40;Barc&#41;&#46; 2019&#59;91&#58;80&#8211;87&#46;</p>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0020">Previous presentation&#58; This study was presented as an oral communication under the title &#8220;<span class="elsevierStyleItalic">Dolor Zero&#8221; en planta de hospitalizaci&#243;n pedi&#225;trica&#58; &#191;ficci&#243;n&#44; realidad&#8230; o realidad virtual&#63;</span> At the 66 Congress of the Asociaci&#243;n Espa&#241;ola de Pediatr&#237;a&#59; June 7&#8211;9&#44; 2018&#59; Zaragoza&#44; Spain&#46;</p>"
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            "apendice" => "<p id="par0230" class="elsevierStylePara elsevierViewall">The following are the supplementary data to this article&#58;<elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>"
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            "titulo" => "Supplementary data"
            "identificador" => "sec0080"
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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">&#40;a&#41; Woxter Neo VR1 glasses connected to a mobile device&#46; &#40;b&#41; Patient using the VR glasses during lumbar puncture&#46; &#40;c&#41; Patient using the VR glasses during a blood draw&#46;</p>"
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Blood draw&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Peripheral venous catheter placement&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">Lumbar puncture&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1 &#40;1&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
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          "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">We compared quantitative variables by means of the Kruskal&#8211;Wallis test and categorical variables by means of the Fisher exact test or chi square test&#46; The data are summarised as median and interquartile range or as percentages&#46;</p><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">IQR&#44; interquartile range&#59; VR&#44; virtual reality&#46;</p>"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Control group &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>18&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Number of punctures&#44; median &#40;IQR&#41;</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Serum</span><span class="elsevierStyleItalic">methaemoglobin level &#40;&#37;&#41;&#44; median &#40;IQR&#41;</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1 &#40;0&#46;5&#8211;2&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#60;&#46;001<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Anxiety reported by patient</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">0&#46;5 &#40;0&#8211;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">&#46;009<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Pain reported by parents</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">1 &#40;0&#8211;2&#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
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                  \t\t\t\t">&#60;&#46;001<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">&#42;</span></a>&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 " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Anxiety reported by parents</span>&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="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&#46;0 &#40;2&#46;25&#8211;3&#46;75&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">1 &#40;0&#8211;1&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">1 &#40;0&#8211;1&#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
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                  \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"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Pain reported by health providers</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0 &#40;0&#8211;1&#41;&nbsp;\t\t\t\t\t\t\n
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Original Article
Reducing the pain in invasive procedures during paediatric hospital admissions: Fiction, reality or virtual reality?
Disminuyendo el dolor en los procedimientos invasivos durante la hospitalización pediátrica: ¿ficción, realidad o realidad virtual?
Blanca Toledo del Castilloa,b,
Corresponding author
btoledodc@hotmail.com

Corresponding author.
, Jorge Alejandro Pérez Torresb, Lidia Morente Sánchezb, María Escobar Castellanosb, Laura Escobar Fernándezb, María Isabel González Sáncheza,b, Rosa Rodríguez Fernándeza,b
a Instituto de Investigación Sanitaria Gregorio Marañón (IISGM), Madrid, Spain
b Sección de Hospitalización Pediátrica, Servicio de Pediatría, Hospital General Universitario Gregorio Marañón, Madrid, Spain
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