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Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles: Systematic Review and Meta-analysis

Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles:... Background: Virtual reality (VR) is used as a distraction measure during painful clinical procedures associated with the use of needles. These procedures include vaccinations, blood draws, or the administration of medications, which can cause children to feel increased levels of pain and fear. Objective: The objective of this study was to collect and analyze the current evidence regarding the effectiveness of VR as a tool to distract children from pain and fear during needle procedures as compared to that of standard techniques. Methods: A systematic review and meta-analysis was performed. We included randomized clinical trials (RCTs) or quasi-RCTs with participants younger than 21 years who underwent needle procedures in which the main distraction measure used was VR and where the main outcome measure was pain. The databases searched included the PubMed, Web of Science, Scopus, PsycINFO, CINAHL, and Cochrane libraries. In this systematic review, the studies were analyzed by applying the Critical Appraisal Skills Program guide in Spanish and the Jadad scale. In the meta-analysis, the effect size of the studies was analyzed based on the results for pain and fear in children. Results: From 665 unique search results, 21 studies were included in this systematic review, most of which reported low methodological quality. The study sample cohorts ranged from a minimum of 15 participants to a maximum of 220 participants. Ten studies were included in the meta-analysis. The global effect of using VR as a distraction measure was a significant reduction in pain (inverse variance [IV] –2.37, 95% CI –3.20 to –1.54; Z=5.58; P<.001) and fear (IV –1.26, 95% CI –1.89 to –0.63; Z=3.92; P<.001) in children in the experimental groups. Conclusions: The quality of the studies was mostly low. The main limitations were the impossibility of blinding the participants and health care personnel to the VR intervention. Nonetheless, the use of VR as a distraction measure was effective in reducing pain and fear in children during procedures involving needles. (JMIR Serious Games 2022;10(3):e35008) doi: 10.2196/35008 KEYWORDS virtual reality; pain; fear; pediatric; needle; child; injection; VR; systematic review; meta-analysis; paediatric https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al and fear while undergoing needle procedures compared to the Introduction distractions by standard techniques. Regarding the specific objectives, our first aim was to analyze the studies included in Background the systematic review to assess their methodological quality. The main problems experienced in pediatric care are pain and Second, our objective was to analyze the effect of the fear. This is especially true for procedures associated with the randomized controlled trials (RCTs) included in our use of needles such as vaccinations, blood draws, or the meta-analysis. administration of medications [1,2]. This causes difficulties in Research Question the administration of health care and can result in parental dissatisfaction [3]. The International Association for the Study Is the use of VR as a distraction measure effective for reducing of Pain defines pain as “an unpleasant sensory and emotional the perception of pain in children while performing needle experience associated with actual or potential tissue damage or procedures? described in terms of such damage” [4]. Pain, therefore, is a complex experience that involves sensory, cognitive, behavioral, Methods and psychological factors [5]. In turn, fear is an immediate alarm reaction to danger, which triggers an escape behavior and an Study Design intense physiological response [6]. The pain and fear that This is a systematic review and meta-analysis of studies that children experience when facing needle procedures is a concern evaluated the effect of VR as the main distraction measure to for health care professionals. Therefore, various techniques are reduce the perception of pain in children undergoing needle being studied to help reduce its impact. Indeed, the procedures. administration of drugs is not always indicated to reduce pain Inclusion Criteria and fear in these procedures [7]. Rather, the use of distractions during painful procedures appears to be one of the most effective Studies were included in this paper based on the following ways to decrease pain and distress in children [8]. For example, criteria: (1) the participants were younger than 21 years; (2) music or toys have already been effectively used as distraction studies where the use of VR was the primary distraction means measures to help reduce pediatric pain. Nonetheless, virtual used during needle procedures; (3) studies, including pilot reality (VR) is a novel technique that has been proven to be studies, with an RCT or quasi-RCT methodological design; and more effective than traditional methods [3]. (4) studies where the main outcome measure was pain. VR is a computer technology that creates a 3D-simulated Data Sources artificial environment [5]. It usually requires wearing special For this study, we consulted the PubMed, Web of Science, glasses that cover a wide field of vision and which include Scopus, PsycINFO, CINAHL, and Cochrane databases. The motion tracking systems at the eye level [9]. These glasses can literature search was conducted between January 2020 and June be connected to a computer or a telephone [5]. VR makes it 2021. Two independent researchers comprehensively reviewed easier to divert attention away from the painful procedure so the results obtained in each of the studies and subsequently that children will have a slower response to pain signals by compared the selected papers. counteracting them with an experience of pleasant stimuli [10,11]. Several studies have evaluated the use of VR as a Research Strategy distraction measure during painful procedures such as The medical subject heading keyword terms used in the search venipuncture [3,12-15], tooth extraction [16-19], or burns were reality, virtual, virtual reality, virtual reality headset, virtual treatment [20-24]. However, these studies have certain reality exposure therapy, child*, pediatric, adolescent, limitations such as the use of small sample sizes or poor intervention, program*, pain, ache, procedural, acute pain, pain methodological quality. Comparing the findings of these studies perception, fear, and fears. All these terms were combined with is difficult because the works published to date have evaluated the Boolean AND and OR functions and no filters were applied a wide breadth of invasive medical care types. Furthermore, we to limit the search. Search strategies were created specifically were able to identify only 2 systematic reviews and 1 for each database by using the medical subject heading terms meta-analysis that analyzed the use of VR in children. However, described above (Multimedia Appendix 1). No publication date these studies had evaluated several medical procedures, or language restrictions were applied. including dental procedures, burns treatments, oncological care, Study Selection Process or physical therapy sessions [3,25]. The variation in the procedural conditions using VR implies a lack of evidence to First, we evaluated the scientific literature to identify studies support its use in needle procedures. Thus, highlighting these that met the inclusion criteria. To do this, we read the title and issues, this systematic review and meta-analysis focused on the abstract from each of the identified papers. Two of our authors effect of VR on pain and fear during needle procedures in (RCG and MLV) independently performed an initial screening children. by reading the study titles and abstracts. After this process, the researchers discussed their results based on the predetermined Objectives inclusion and exclusion criteria. There was a 6% discrepancy The general objective of this study was to collect and analyze in the opinions of these authors, which was resolved by further the current evidence available regarding the effectiveness of discussion to reach a consensus. VR as a tool to distract pediatric patients from potential pain https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al included different rates of withdrawals between groups and was Data Extraction judged according to the proportion of incomplete outcome data. Once the full-text papers were selected, 2 authors (RCG and Finally, reporting bias described selective reporting. CRZ) analyzed the studies based on their general characteristics and methodological quality. In this process, these researchers The Cochrane Collaboration Handbook for Systematic Reviews jointly extracted the relevant information from these for Interventions was used to analyze the risk of bias from publications. This information was transferred to 2 tables. First, studies not included in the meta-analysis. This analysis included the general characteristics of the studies were included in selection bias when randomization was analyzed, performance Multimedia Appendix 2. Subsequently, the methodological bias when blinding between participants and personnel was quality of all the studies was analyzed based on the Critical tested, detection bias when blinding between participants and Appraisal Skills Program guide in Spanish (CASPe) scale, and outcome assessors was tested, attrition bias where dropouts this information was completed by performing a quantitative were analyzed, and reporting bias where they were analyzed, evaluation using the Jadad scale; these data are shown in and the outcomes were selectively reported [29]. Multimedia Appendix 3. Analysis of the Meta-analysis Data Protocol and Registration Employing the random effects model in Review Manager This systematic review was registered with the Open Science software (RevMan v.5.2; Cochrane Collaboration), 2 Framework (Osf.io/cd8nr) in October 2021. meta-analyses were carried out to examine the overall effect of the intervention on pain and fear in children. We used this model Data List because we wanted to limit overestimation of the effect size. The general characteristics (Multimedia Appendix 2) of the The studies included had an RCT design and contained complete studies provide information, including the following elements: statistical information; the effects were expressed as mean author, study year and country, overall sample size, number of differences with a 95% CI. The heterogeneity of the studies was participants in the control and intervention groups, participant assessed by calculating the I statistic, and the variance between age, study type, variables and measurement instruments used, the studies was examined by calculating Tau . When the and finally, positive (P<.05), negative (P>.05), or inconclusive significance level was set at .05, the heterogeneity of the studies (±) results. Multimedia Appendix 3 provides an assessment of we included was high for both these variables (94% and 96%, the methodological quality of the studies that we included in respectively; P<.01). Lastly, to increase the precision of the this review according to the CASPe [26]. This tool organizes effect size estimator, the effect sizes proposed by Cohen [30] data about each study into 3 sections: validity, results, and were calculated (small effect, d=0.20; medium effect, d=0.50; applicability. We used the Jadad scale [27], which assesses and large effect, d=0.80). research quality on a scale of 0 to 5 points according to the responses to a series of questions, to complete this information. Results Scores below 3 points suggested that little methodological rigor had been applied during the study in question. This allowed us Search Results to objectively assess the following parameters: random sequence As shown in Figure 1, our initial search returned a total of 665 generation, allocation concealment, blinding of participants and papers. After eliminating 211 duplicates, 2 researchers (RCG personnel, and blinding to the outcome assessment. To guarantee and MLV) initially screened the 454 studies by reading their the quality of this meta-analysis, we followed the PRISMA titles and abstracts. There was a 6% discrepancy in their (Preferred Reporting Items for Systematic Reviews and opinions, which was resolved by reaching a consensus based Meta-Analysis) statement guidelines [28] (Tables S4 and S5 of on the eligibility criteria of the papers. This selection further Multimedia Appendices 4 and 5, respectively). reduced the sample to 96 manuscripts. Reading the full texts of Risk of Bias Assessment these papers revealed that only 46 papers had focused on the The Cochrane Collaboration Risk of Bias Tool [29] was used use of VR to reduce pain during procedures involving needles, to assess the risk of bias in the studies included in the some of which had also addressed fear in these patients. Lastly, meta-analysis in 5 categories: selection bias, performance bias, 3 of our authors (RCG, MLV, and CRZ) critically read all these detection bias, attrition bias, and reporting bias. For selection papers and excluded another 25 papers because they did not bias, which refers to the introduction of differences between meet the inclusion criteria, as described in Figure 1. Thus, 21 groups at baseline, random sequence generation and allocation studies were finally included in this systematic review, and only concealment were judged. Performance bias was analyzed based 10 were eligible for inclusion in the meta-analysis [31] (Figure on blinding of the participants and personnel. Detection bias 1). referred to blinding of the outcome assessors. Attrition bias https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al Figure 1. Flowchart showing the screening and selection process for the papers included in this systematic review and meta-analysis. Created using the guidelines on Page et al [31]. WOS: Web of Science; *Consider if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers); **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools. of the studies collected data for less than a year General Characteristics of the Studies [32,34-37,39-41,43,44,46,47], 10% (2/21) had done so for 13 Multimedia Appendix 2 summarizes the main characteristics months or more [33,45], and 33% (7/21) of them had not and results of the selected studies. The 21 studies ranged from reported this information [38,42,48-52]. We identified most of the year 2002 to 2021; 76% (16/21) of them had been published the studies (16/21, 76%) as RCTs [32-34,36-40,42-47,49,52] between 2018 and 2021 [32-47], while the rest had been but 10% (2/21) were pilot studies [48,50] and 10% (2/21) were published between 2002 and 2007 [48-52]. Most of the research quasi-experimental studies [35,41]. (11/21, 52%) had been conducted in North America Quality of the Studies [33,35-37,39,40,48-52], but 14% (3/21) of the work was from Europe [34,35,37] and 33% (7/21) had been performed in Asia We assessed the quality of the studies according to the CASPe [32,36,38-40,44,47]. Regarding the contexts of these VR studies, and Jadad guidelines (see Multimedia Appendix 3). Only 14% 95% (20/21) of them had been carried out in hospitals (3/21) of the studies were rated as high quality [37,44,45], with [32-50,52], while 5% (1/21) had been completed in primary the remaining 86% (18/21) being rated as low quality health care centers [51]. Most of the procedures involving [32-36,38-43,46-52]. Specifically regarding the random needles in which VR had been used were venipunctures (14/21, assignment of patients to the study groups, 10% (2/21) [34,35] 67%) [32,34,35,37-43,45,47,49,51], followed by subcutaneous of the studies had not carried out randomization. The participants venous puncture for reservoir-type venous access (4/21, 19%) had been randomly assigned in 19% (4/21) of the studies [33,36,48,52]. One study had used VR during lumbar punctures [32,49,50,52] but none of these authors had specified the type [50]. The remaining one had conducted research analyzing of procedure they had used to perform the randomization, and venipunctures or intramuscular injections [42]. The study sample this information was uncertain in another study (1/21, 5%) [41]. cohorts ranged from a minimum of 15 [41] to a maximum of The participants had been randomly assigned in the remaining 220 individuals [33]; 43% (9/21) of the studies had analyzed a 71% (15/21) of the studies [33,36-40,42-48,51]. Given the active sample comprising fewer than 100 participants nature of these interventions, most of the studies had not blinded [35,37,41-43,48,49,51,52]. In the different studies, the age of the participants to their group assignment. Moreover, only 4 the children ranged from 4 years to 21 years, while the study (19%) of them [37,39,45,52] had blinded the group assignment duration varied between 14 weeks and 20 months; 57% (12/21) to the observers or health professionals, although none of them https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al had been able to maintain this blinding until the end of the work. [32,35,39-41,44,46-48]. Finally, the benefits of the intervention The preintervention VR and control group characteristics were had exceeded the costs or damages that could have been similar in terms of sex, age, and other sociodemographic produced in all of the cases [32-52]. variables in 15 (71%) of the 21 studies Risk of Bias [32,33,36-39,42-45,47-49,51,52]. In 91% (19/21) of the cases, The Cochrane Collaboration Risk of Bias Tool [29] was used both groups had been treated in a similar way, regardless of the to assess the risk of bias of the 10 studies included in the intervention that had been performed [32,33,35-39,41-45,47-53]. metanalysis by 2 reviewers. Based on these tools, only 1 of the There were insufficient reports on the flow of participants studies was at high risk of bias, 8 at unclear risk of bias, and 1 through the studies in 38% (8/21) of the papers retrieved, which at low risk of bias (Figure 2). Based on the Cochrane made it difficult to determine the level of dropouts Collaboration criteria for different types of bias, we analyzed [34,41,42,48-52]. Only 1 study (5%) provided information about the 11 studies not included in the meta-analysis. As shown in the effect size [33]. The cohorts comprised 15 to 59 children in Multimedia Appendix 3, the biases related to blinding, both of 43% (9/21) of the studies, and the authors themselves classified the participants of the personnel as well as to the outcome these samples as small [35,41-43,48-52]. Furthermore, 5% assessment, reached the highest levels in 82% (9/11) of the (1/21) of the samples were of children with specific pathologies studies. Of the 11 studies, most of the studies had a moderate [34]. Regarding extrapolation of the results, the data could only risk of bias (5/11, 46%); 3 (27%) studies were identified as be generalized or considered for extrapolation in 8 of the 21 having a high risk of bias and 2 (18%) studies had a low risk papers we reviewed [32,33,37,39,40,43-45]. Additionally, only of bias. One study (9%) was classified as having a low risk of 43% (9/21) of the studies had collected information about the bias but no information on blinding could be obtained. participant acceptance and satisfaction with the VR intervention Figure 2. Risk of bias graph and summary [34,36,40,41,43,45,47,51,52]. studies in 10 of the 21 studies (Figure 3). The main results Effects of VR on the Perception of Pain showed statistically significant differences in favor of the The studies were heterogeneous in both the measured outcomes experimental group in the studies by Wolitzky et al [52] (d=1.85; inverse variance [IV] –3.40, 95% CI –5.01 to –1.79) and (I =89-92). We were able to analyze the effect size of the pain https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al Diaz-Hennessey et al [41] (d=1.43; IV –2.68, 95% CI –4.57 to a control group (d=0.89; IV –2.5, 95% CI –3.80 to –1.20). The –0.79). Likewise, pain was significantly reduced in the studies study by Chen et al [40] also found a significant reduction in by Koç Özkan and Polat [47] (d=0.17; IV –4.84, 95% CI –5.57 pain in the intervention group (d=0.37; IV –1.00, 95% CI –1.90 to –4.11), the intervention by Piskorz et al [34] using both to –0.10). As shown in Figure 3, the global effect of using VR passive VR (d=0.97; IV –1.88, 95% CI –3.10 to –0.66) and as a distraction measure had significantly reduced pain in active VR (d=1.45; IV –2.55, 95% CI –3.62 to –1.48), and in children in the experimental groups (IV –2.37, 95% CI –3.20 the studies by Erdogan and Aytekin Ozdemir [43] in VR versus to –1.54; Z=5.58; P<.001). Figure 3. A random forest plot of the association between pain and study group (control vs virtual reality) [34,36,40,41,43,45,47,51,52]. b: Wong-Baker Faces Pain Rating Scale; Buzzy: a device that applies local cold and vibration at the injection site; DC: distraction card; IV: inverse variance; VR: virtual reality. significantly reduced in the studies by Erdogan and Aytekin Effects of VR on Fear Ozdemir [43] in the VR versus control group (d=1.17; IV –1.30, We were only able to analyze the fear variable in 5 of the 21 95% CI –1.82 to –0.78) and the intervention by Piskorz et al studies. The use of VR produced a statistically significant [34] in active VR (d=1.36; IV –2.60, 95% CI –3.76 to –1.44]. reduction in fear in the experimental groups in the study by As shown in Figure 4, the global effect of using VR as a Chen et al [40] (d=0.35; IV –0.46, 95% CI –0.90 to –0.02) and distraction measure had significantly reduced the perception of a large reduction in the Koç Özkan and Polat study [47] (d=0.17; fear in children in the experimental groups (IV –1.26, 95% CI IV –2.36, 95% CI –2.74 to –1.98). Likewise, fear was –1.89 to –0.63; Z=3.92; P<.001). Figure 4. A random forest plot of the association between fear and study group (control vs virtual reality) [34,40,43,47,51]. Buzzy: a device that applies local cold and vibration at the injection site; DC: distraction card; IV: inverse variance; VR: virtual reality. difficult to compare these results with those of other studies Discussion because most of them included different medical processes or did not analyze the effect on the children’s fear. However, other To the best of our knowledge, this is the first systematic review meta-analyses found similar results, indicating that the effects with a meta-analysis designed to examine the effectiveness of of VR are beneficial in reducing fear during medical processes the use of VR as a distraction measure to reduce pain and fear involving pain, especially in children [54]. However, these in the pediatric population during procedures involving needles. comparisons must be analyzed with caution because neither the Based on the high effect sizes that we found, our results suggest studies included nor their participants were homogeneous in that VR distraction is possibly more effective than the habitual terms of age or characteristics, the medical procedures analyzed, routine or other distractions used during needle procedures to or the tools used to measure pain. reduce the perception of pain and fear felt by children. It is https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al Most of the papers included in this review found that VR had low. However, some studies with low quality or even small a positive effect by helping to reduce pain in children. Of note, samples showed important effects. We assume that in the future, all the studies that had included more than 100 participants and a meta-regression model could be used to expand existing had used the Wong-Baker Faces Pain Rating Scale (WBFPS) knowledge about these intervention types and their had reported statistically significant results. This may be because methodological quality. For this reason, this systematic review this visual assessment scale is more effective in assessing pain and meta-analysis highlights the need to design and implement in children than other scales that use numerical assessment new research with high methodological quality that would allow scales such as the visual analog scale (VAS) for pain [55]. extraneous variables to be isolated, favoring the cause-effect Although the VAS is a reliable method for assessing acute pain, relationship. The principal reasons for the studies included in children younger than 7 years may have difficulty in its use, as this meta-analysis to be of low quality were that it was nearly indicated by the reduced reliability of the results reported in impossible to blind both the participants and health care these studies [56]. In addition, the VAS and WBFPS have been personnel to the VR intervention because of the nature of these widely used in studies evaluating pain in other procedures such devices [76]. Furthermore, in many cases, the absence of as wound healing [57], physiotherapy sessions after complex randomization was justified for ethical reasons. Indeed, more surgical interventions [58], or dental procedures [59] in which than half of the studies we examined had considered small they produced positive results. sample sizes of fewer than 100 participants [77], which, in addition to being unreliable and inefficient, can lead to Most of the papers included in this review overestimation of the study effect size and can produce low [32,33,35,37-41,44,45,47-52] had analyzed the effect of VR on reproducibility of the results. Finally, chronological age and pain and fear in pediatric patients with cancer during neurological development are among the factors that influenced venipuncture or reservoir puncture procedures. Furthermore, children’s perceptions of pain and fear of procedures involving most of the studies we retrieved (20/21, 95%) had been carried needles, and therefore, adjusting the age of children to less than out in hospitals, while only 5% (1/21) had been carried out in 21 years should be considered in future studies [78]. Blinding primary health care centers. This may have been a result of the and randomization are also the issues that were identified in the health care provision resources available at the sites where these risk of bias analysis of studies not included in the meta-analysis. previous studies had been carried out, given that most of this The studies included in the meta-analysis generally had a low work had been carried out in hospitals, thanks to the teaching level of risk, while studies not included tended to have a higher function of these centers [60-62]. These data indicate that scant level of risk of bias. This may be due both to the fact that research has been carried out for this level of care, which is meta-analysis studies are more robust and to the use of different surprising, considering that needle procedures are frequent in measurement tools in these papers. primary care contexts because of the systematic vaccination programs carried out in the pediatric population. Among other The main limitations of this work were, on the one hand, the possible explanations, perhaps this lack of research can be lack of studies with nonsignificant results available in the explained by health care staff overload or low levels of scientific literature. This meant that we may not have included motivation among professionals or toward the support of all the relevant studies, and therefore, it was not possible to research [63-67]. However, 2 study protocols have recently control for publication bias [79]. On the other hand, although been published that will aim to evaluate the effectiveness of the random effects model that we used favored the most realistic VR against pain during vaccination in the pediatric population observation of the data by specifically weighting each study, through RCTs with estimated sample sizes of 100 [68] to more the heterogeneity of the included studies, both in terms of their than 400 participants [69]. outcome measures and their methodological approaches, means that we must be cautious about the interpretation of our results. Although we found that VR is effective in reducing children’s This problem was also identified in a similar recent fear, very few studies have demonstrated the usefulness of VR meta-analysis in which heterogeneity was found in studies with in reducing fear during procedures involving needles [40,47]. young patients [54]. Finally, the studies included did not address Thus, the absence of a validated scale to measure this variable the effect of VR in children younger than 4 years, which implies may be inhibiting its proper evaluation [70]. According to a limitation of the results when it comes to generalizing this Taddio et al [71], most studies that measure fear do so by using effect in all children. Based on all the above, the methodological questionnaires developed by the investigators, nonvalidated design of future work must adequately calculate the required scales, or scales for measuring anxiety [72,73]. Thus, this review sample sizes and use appropriate sampling, participant study reveals the lack of consensus on the most appropriate group allocations, and blinding techniques to be able to instruments for evaluating and clearly differentiating between extrapolate any data obtained to the wider pediatric population. fear and distress in the pediatric population. Although in clinical This review was limited by the quality of the studies it included. practice, the difference between fear, anxiety, and stress may Generalization of these findings to younger children should also not always be relevant, these represent different theoretical be done with caution because the studies we considered had not constructs, which are not always rigorously differentiated. included children younger than 4 years. Notwithstanding, both fear and distress are important factors that are related to and impact the pain perceived by children In conclusion, the findings of this review indicate that VR could [74,75]. be a feasible distraction measure to reduce the perception of pain and fear in the pediatric population during procedures Of note, the quality of the studies included in this systematic involving needles. However, these results are limited by the review (based on CASPe and Jadad assessments) was mostly https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al heterogeneity of the studies included. In this sense, more trials will be needed in the future. with larger sample sizes and quality methodological techniques Acknowledgments This work was supported by a grant from the University CEU Cardenal Herrera (ICLINIC/1906).  Authors' Contributions MLV and CRZ conceptualized and designed the study, drafted the initial manuscript, designed the data collection instruments, and reviewed the manuscript. RCG collected the data, carried out the analysis, and revised the manuscript. LP drafted the initial manuscript. LGG and MISL critically reviewed the manuscript for important intellectual content. All the authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. Conflicts of Interest None declared. Multimedia Appendix 1 Search strategies. [DOC File , 33 KB-Multimedia Appendix 1] Multimedia Appendix 2 General characteristics and results of the studies in this review. [DOC File , 211 KB-Multimedia Appendix 2] Multimedia Appendix 3 Evaluation of the methodological quality. [DOC File , 77 KB-Multimedia Appendix 3] Multimedia Appendix 4 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) checklist. [DOC File , 88 KB-Multimedia Appendix 4] Multimedia Appendix 5 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis)_2020_Abstract_checklist. [DOC File , 48 KB-Multimedia Appendix 5] References 1. Hoffman HG. Virtual-reality therapy. Sci Am 2004 Aug;291(2):58-65. [doi: 10.1038/scientificamerican0804-58] [Medline: 15298120] 2. Hedén L, von Essen L, Ljungman G. 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[doi: 10.1002/14651858.MR000006.pub3] [Medline: 19160345] Abbreviations CASPe: Critical Appraisal Skills Program guide in Spanish IV: inverse variance RCT: randomized controlled trial VAS: visual analog scale VR: virtual reality WBFPS: Wong-Baker Faces Pain Rating Scale Edited by N Zary; submitted 19.11.21; peer-reviewed by B Nievas Soriano, KA Nguyen; comments to author 22.01.22; revised version received 19.03.22; accepted 13.05.22; published 09.08.22 Please cite as: Lluesma-Vidal M, Carcelén González R, García-Garcés L, Sánchez-López MI, Peyro L, Ruiz-Zaldibar C JMIR Serious Games 2022;10(3):e35008 URL: https://games.jmir.org/2022/3/e35008 doi: 10.2196/35008 PMID: ©Marta Lluesma-Vidal, Raquel Carcelén González, Laura García-Garcés, María I Sánchez-López, Loreto Peyro, Cayetana Ruiz-Zaldibar. Originally published in JMIR Serious Games (https://games.jmir.org), 09.08.2022. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Serious Games, is properly cited. The complete bibliographic information, a link to the original publication on https://games.jmir.org, as well as this copyright and license information must be included. https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 12 (page number not for citation purposes) XSL FO RenderX http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JMIR Serious Games JMIR Publications

Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles: Systematic Review and Meta-analysis

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JMIR Publications
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2291-9279
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10.2196/35008
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Abstract

Background: Virtual reality (VR) is used as a distraction measure during painful clinical procedures associated with the use of needles. These procedures include vaccinations, blood draws, or the administration of medications, which can cause children to feel increased levels of pain and fear. Objective: The objective of this study was to collect and analyze the current evidence regarding the effectiveness of VR as a tool to distract children from pain and fear during needle procedures as compared to that of standard techniques. Methods: A systematic review and meta-analysis was performed. We included randomized clinical trials (RCTs) or quasi-RCTs with participants younger than 21 years who underwent needle procedures in which the main distraction measure used was VR and where the main outcome measure was pain. The databases searched included the PubMed, Web of Science, Scopus, PsycINFO, CINAHL, and Cochrane libraries. In this systematic review, the studies were analyzed by applying the Critical Appraisal Skills Program guide in Spanish and the Jadad scale. In the meta-analysis, the effect size of the studies was analyzed based on the results for pain and fear in children. Results: From 665 unique search results, 21 studies were included in this systematic review, most of which reported low methodological quality. The study sample cohorts ranged from a minimum of 15 participants to a maximum of 220 participants. Ten studies were included in the meta-analysis. The global effect of using VR as a distraction measure was a significant reduction in pain (inverse variance [IV] –2.37, 95% CI –3.20 to –1.54; Z=5.58; P<.001) and fear (IV –1.26, 95% CI –1.89 to –0.63; Z=3.92; P<.001) in children in the experimental groups. Conclusions: The quality of the studies was mostly low. The main limitations were the impossibility of blinding the participants and health care personnel to the VR intervention. Nonetheless, the use of VR as a distraction measure was effective in reducing pain and fear in children during procedures involving needles. (JMIR Serious Games 2022;10(3):e35008) doi: 10.2196/35008 KEYWORDS virtual reality; pain; fear; pediatric; needle; child; injection; VR; systematic review; meta-analysis; paediatric https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al and fear while undergoing needle procedures compared to the Introduction distractions by standard techniques. Regarding the specific objectives, our first aim was to analyze the studies included in Background the systematic review to assess their methodological quality. The main problems experienced in pediatric care are pain and Second, our objective was to analyze the effect of the fear. This is especially true for procedures associated with the randomized controlled trials (RCTs) included in our use of needles such as vaccinations, blood draws, or the meta-analysis. administration of medications [1,2]. This causes difficulties in Research Question the administration of health care and can result in parental dissatisfaction [3]. The International Association for the Study Is the use of VR as a distraction measure effective for reducing of Pain defines pain as “an unpleasant sensory and emotional the perception of pain in children while performing needle experience associated with actual or potential tissue damage or procedures? described in terms of such damage” [4]. Pain, therefore, is a complex experience that involves sensory, cognitive, behavioral, Methods and psychological factors [5]. In turn, fear is an immediate alarm reaction to danger, which triggers an escape behavior and an Study Design intense physiological response [6]. The pain and fear that This is a systematic review and meta-analysis of studies that children experience when facing needle procedures is a concern evaluated the effect of VR as the main distraction measure to for health care professionals. Therefore, various techniques are reduce the perception of pain in children undergoing needle being studied to help reduce its impact. Indeed, the procedures. administration of drugs is not always indicated to reduce pain Inclusion Criteria and fear in these procedures [7]. Rather, the use of distractions during painful procedures appears to be one of the most effective Studies were included in this paper based on the following ways to decrease pain and distress in children [8]. For example, criteria: (1) the participants were younger than 21 years; (2) music or toys have already been effectively used as distraction studies where the use of VR was the primary distraction means measures to help reduce pediatric pain. Nonetheless, virtual used during needle procedures; (3) studies, including pilot reality (VR) is a novel technique that has been proven to be studies, with an RCT or quasi-RCT methodological design; and more effective than traditional methods [3]. (4) studies where the main outcome measure was pain. VR is a computer technology that creates a 3D-simulated Data Sources artificial environment [5]. It usually requires wearing special For this study, we consulted the PubMed, Web of Science, glasses that cover a wide field of vision and which include Scopus, PsycINFO, CINAHL, and Cochrane databases. The motion tracking systems at the eye level [9]. These glasses can literature search was conducted between January 2020 and June be connected to a computer or a telephone [5]. VR makes it 2021. Two independent researchers comprehensively reviewed easier to divert attention away from the painful procedure so the results obtained in each of the studies and subsequently that children will have a slower response to pain signals by compared the selected papers. counteracting them with an experience of pleasant stimuli [10,11]. Several studies have evaluated the use of VR as a Research Strategy distraction measure during painful procedures such as The medical subject heading keyword terms used in the search venipuncture [3,12-15], tooth extraction [16-19], or burns were reality, virtual, virtual reality, virtual reality headset, virtual treatment [20-24]. However, these studies have certain reality exposure therapy, child*, pediatric, adolescent, limitations such as the use of small sample sizes or poor intervention, program*, pain, ache, procedural, acute pain, pain methodological quality. Comparing the findings of these studies perception, fear, and fears. All these terms were combined with is difficult because the works published to date have evaluated the Boolean AND and OR functions and no filters were applied a wide breadth of invasive medical care types. Furthermore, we to limit the search. Search strategies were created specifically were able to identify only 2 systematic reviews and 1 for each database by using the medical subject heading terms meta-analysis that analyzed the use of VR in children. However, described above (Multimedia Appendix 1). No publication date these studies had evaluated several medical procedures, or language restrictions were applied. including dental procedures, burns treatments, oncological care, Study Selection Process or physical therapy sessions [3,25]. The variation in the procedural conditions using VR implies a lack of evidence to First, we evaluated the scientific literature to identify studies support its use in needle procedures. Thus, highlighting these that met the inclusion criteria. To do this, we read the title and issues, this systematic review and meta-analysis focused on the abstract from each of the identified papers. Two of our authors effect of VR on pain and fear during needle procedures in (RCG and MLV) independently performed an initial screening children. by reading the study titles and abstracts. After this process, the researchers discussed their results based on the predetermined Objectives inclusion and exclusion criteria. There was a 6% discrepancy The general objective of this study was to collect and analyze in the opinions of these authors, which was resolved by further the current evidence available regarding the effectiveness of discussion to reach a consensus. VR as a tool to distract pediatric patients from potential pain https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al included different rates of withdrawals between groups and was Data Extraction judged according to the proportion of incomplete outcome data. Once the full-text papers were selected, 2 authors (RCG and Finally, reporting bias described selective reporting. CRZ) analyzed the studies based on their general characteristics and methodological quality. In this process, these researchers The Cochrane Collaboration Handbook for Systematic Reviews jointly extracted the relevant information from these for Interventions was used to analyze the risk of bias from publications. This information was transferred to 2 tables. First, studies not included in the meta-analysis. This analysis included the general characteristics of the studies were included in selection bias when randomization was analyzed, performance Multimedia Appendix 2. Subsequently, the methodological bias when blinding between participants and personnel was quality of all the studies was analyzed based on the Critical tested, detection bias when blinding between participants and Appraisal Skills Program guide in Spanish (CASPe) scale, and outcome assessors was tested, attrition bias where dropouts this information was completed by performing a quantitative were analyzed, and reporting bias where they were analyzed, evaluation using the Jadad scale; these data are shown in and the outcomes were selectively reported [29]. Multimedia Appendix 3. Analysis of the Meta-analysis Data Protocol and Registration Employing the random effects model in Review Manager This systematic review was registered with the Open Science software (RevMan v.5.2; Cochrane Collaboration), 2 Framework (Osf.io/cd8nr) in October 2021. meta-analyses were carried out to examine the overall effect of the intervention on pain and fear in children. We used this model Data List because we wanted to limit overestimation of the effect size. The general characteristics (Multimedia Appendix 2) of the The studies included had an RCT design and contained complete studies provide information, including the following elements: statistical information; the effects were expressed as mean author, study year and country, overall sample size, number of differences with a 95% CI. The heterogeneity of the studies was participants in the control and intervention groups, participant assessed by calculating the I statistic, and the variance between age, study type, variables and measurement instruments used, the studies was examined by calculating Tau . When the and finally, positive (P<.05), negative (P>.05), or inconclusive significance level was set at .05, the heterogeneity of the studies (±) results. Multimedia Appendix 3 provides an assessment of we included was high for both these variables (94% and 96%, the methodological quality of the studies that we included in respectively; P<.01). Lastly, to increase the precision of the this review according to the CASPe [26]. This tool organizes effect size estimator, the effect sizes proposed by Cohen [30] data about each study into 3 sections: validity, results, and were calculated (small effect, d=0.20; medium effect, d=0.50; applicability. We used the Jadad scale [27], which assesses and large effect, d=0.80). research quality on a scale of 0 to 5 points according to the responses to a series of questions, to complete this information. Results Scores below 3 points suggested that little methodological rigor had been applied during the study in question. This allowed us Search Results to objectively assess the following parameters: random sequence As shown in Figure 1, our initial search returned a total of 665 generation, allocation concealment, blinding of participants and papers. After eliminating 211 duplicates, 2 researchers (RCG personnel, and blinding to the outcome assessment. To guarantee and MLV) initially screened the 454 studies by reading their the quality of this meta-analysis, we followed the PRISMA titles and abstracts. There was a 6% discrepancy in their (Preferred Reporting Items for Systematic Reviews and opinions, which was resolved by reaching a consensus based Meta-Analysis) statement guidelines [28] (Tables S4 and S5 of on the eligibility criteria of the papers. This selection further Multimedia Appendices 4 and 5, respectively). reduced the sample to 96 manuscripts. Reading the full texts of Risk of Bias Assessment these papers revealed that only 46 papers had focused on the The Cochrane Collaboration Risk of Bias Tool [29] was used use of VR to reduce pain during procedures involving needles, to assess the risk of bias in the studies included in the some of which had also addressed fear in these patients. Lastly, meta-analysis in 5 categories: selection bias, performance bias, 3 of our authors (RCG, MLV, and CRZ) critically read all these detection bias, attrition bias, and reporting bias. For selection papers and excluded another 25 papers because they did not bias, which refers to the introduction of differences between meet the inclusion criteria, as described in Figure 1. Thus, 21 groups at baseline, random sequence generation and allocation studies were finally included in this systematic review, and only concealment were judged. Performance bias was analyzed based 10 were eligible for inclusion in the meta-analysis [31] (Figure on blinding of the participants and personnel. Detection bias 1). referred to blinding of the outcome assessors. Attrition bias https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al Figure 1. Flowchart showing the screening and selection process for the papers included in this systematic review and meta-analysis. Created using the guidelines on Page et al [31]. WOS: Web of Science; *Consider if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers); **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools. of the studies collected data for less than a year General Characteristics of the Studies [32,34-37,39-41,43,44,46,47], 10% (2/21) had done so for 13 Multimedia Appendix 2 summarizes the main characteristics months or more [33,45], and 33% (7/21) of them had not and results of the selected studies. The 21 studies ranged from reported this information [38,42,48-52]. We identified most of the year 2002 to 2021; 76% (16/21) of them had been published the studies (16/21, 76%) as RCTs [32-34,36-40,42-47,49,52] between 2018 and 2021 [32-47], while the rest had been but 10% (2/21) were pilot studies [48,50] and 10% (2/21) were published between 2002 and 2007 [48-52]. Most of the research quasi-experimental studies [35,41]. (11/21, 52%) had been conducted in North America Quality of the Studies [33,35-37,39,40,48-52], but 14% (3/21) of the work was from Europe [34,35,37] and 33% (7/21) had been performed in Asia We assessed the quality of the studies according to the CASPe [32,36,38-40,44,47]. Regarding the contexts of these VR studies, and Jadad guidelines (see Multimedia Appendix 3). Only 14% 95% (20/21) of them had been carried out in hospitals (3/21) of the studies were rated as high quality [37,44,45], with [32-50,52], while 5% (1/21) had been completed in primary the remaining 86% (18/21) being rated as low quality health care centers [51]. Most of the procedures involving [32-36,38-43,46-52]. Specifically regarding the random needles in which VR had been used were venipunctures (14/21, assignment of patients to the study groups, 10% (2/21) [34,35] 67%) [32,34,35,37-43,45,47,49,51], followed by subcutaneous of the studies had not carried out randomization. The participants venous puncture for reservoir-type venous access (4/21, 19%) had been randomly assigned in 19% (4/21) of the studies [33,36,48,52]. One study had used VR during lumbar punctures [32,49,50,52] but none of these authors had specified the type [50]. The remaining one had conducted research analyzing of procedure they had used to perform the randomization, and venipunctures or intramuscular injections [42]. The study sample this information was uncertain in another study (1/21, 5%) [41]. cohorts ranged from a minimum of 15 [41] to a maximum of The participants had been randomly assigned in the remaining 220 individuals [33]; 43% (9/21) of the studies had analyzed a 71% (15/21) of the studies [33,36-40,42-48,51]. Given the active sample comprising fewer than 100 participants nature of these interventions, most of the studies had not blinded [35,37,41-43,48,49,51,52]. In the different studies, the age of the participants to their group assignment. Moreover, only 4 the children ranged from 4 years to 21 years, while the study (19%) of them [37,39,45,52] had blinded the group assignment duration varied between 14 weeks and 20 months; 57% (12/21) to the observers or health professionals, although none of them https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al had been able to maintain this blinding until the end of the work. [32,35,39-41,44,46-48]. Finally, the benefits of the intervention The preintervention VR and control group characteristics were had exceeded the costs or damages that could have been similar in terms of sex, age, and other sociodemographic produced in all of the cases [32-52]. variables in 15 (71%) of the 21 studies Risk of Bias [32,33,36-39,42-45,47-49,51,52]. In 91% (19/21) of the cases, The Cochrane Collaboration Risk of Bias Tool [29] was used both groups had been treated in a similar way, regardless of the to assess the risk of bias of the 10 studies included in the intervention that had been performed [32,33,35-39,41-45,47-53]. metanalysis by 2 reviewers. Based on these tools, only 1 of the There were insufficient reports on the flow of participants studies was at high risk of bias, 8 at unclear risk of bias, and 1 through the studies in 38% (8/21) of the papers retrieved, which at low risk of bias (Figure 2). Based on the Cochrane made it difficult to determine the level of dropouts Collaboration criteria for different types of bias, we analyzed [34,41,42,48-52]. Only 1 study (5%) provided information about the 11 studies not included in the meta-analysis. As shown in the effect size [33]. The cohorts comprised 15 to 59 children in Multimedia Appendix 3, the biases related to blinding, both of 43% (9/21) of the studies, and the authors themselves classified the participants of the personnel as well as to the outcome these samples as small [35,41-43,48-52]. Furthermore, 5% assessment, reached the highest levels in 82% (9/11) of the (1/21) of the samples were of children with specific pathologies studies. Of the 11 studies, most of the studies had a moderate [34]. Regarding extrapolation of the results, the data could only risk of bias (5/11, 46%); 3 (27%) studies were identified as be generalized or considered for extrapolation in 8 of the 21 having a high risk of bias and 2 (18%) studies had a low risk papers we reviewed [32,33,37,39,40,43-45]. Additionally, only of bias. One study (9%) was classified as having a low risk of 43% (9/21) of the studies had collected information about the bias but no information on blinding could be obtained. participant acceptance and satisfaction with the VR intervention Figure 2. Risk of bias graph and summary [34,36,40,41,43,45,47,51,52]. studies in 10 of the 21 studies (Figure 3). The main results Effects of VR on the Perception of Pain showed statistically significant differences in favor of the The studies were heterogeneous in both the measured outcomes experimental group in the studies by Wolitzky et al [52] (d=1.85; inverse variance [IV] –3.40, 95% CI –5.01 to –1.79) and (I =89-92). We were able to analyze the effect size of the pain https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al Diaz-Hennessey et al [41] (d=1.43; IV –2.68, 95% CI –4.57 to a control group (d=0.89; IV –2.5, 95% CI –3.80 to –1.20). The –0.79). Likewise, pain was significantly reduced in the studies study by Chen et al [40] also found a significant reduction in by Koç Özkan and Polat [47] (d=0.17; IV –4.84, 95% CI –5.57 pain in the intervention group (d=0.37; IV –1.00, 95% CI –1.90 to –4.11), the intervention by Piskorz et al [34] using both to –0.10). As shown in Figure 3, the global effect of using VR passive VR (d=0.97; IV –1.88, 95% CI –3.10 to –0.66) and as a distraction measure had significantly reduced pain in active VR (d=1.45; IV –2.55, 95% CI –3.62 to –1.48), and in children in the experimental groups (IV –2.37, 95% CI –3.20 the studies by Erdogan and Aytekin Ozdemir [43] in VR versus to –1.54; Z=5.58; P<.001). Figure 3. A random forest plot of the association between pain and study group (control vs virtual reality) [34,36,40,41,43,45,47,51,52]. b: Wong-Baker Faces Pain Rating Scale; Buzzy: a device that applies local cold and vibration at the injection site; DC: distraction card; IV: inverse variance; VR: virtual reality. significantly reduced in the studies by Erdogan and Aytekin Effects of VR on Fear Ozdemir [43] in the VR versus control group (d=1.17; IV –1.30, We were only able to analyze the fear variable in 5 of the 21 95% CI –1.82 to –0.78) and the intervention by Piskorz et al studies. The use of VR produced a statistically significant [34] in active VR (d=1.36; IV –2.60, 95% CI –3.76 to –1.44]. reduction in fear in the experimental groups in the study by As shown in Figure 4, the global effect of using VR as a Chen et al [40] (d=0.35; IV –0.46, 95% CI –0.90 to –0.02) and distraction measure had significantly reduced the perception of a large reduction in the Koç Özkan and Polat study [47] (d=0.17; fear in children in the experimental groups (IV –1.26, 95% CI IV –2.36, 95% CI –2.74 to –1.98). Likewise, fear was –1.89 to –0.63; Z=3.92; P<.001). Figure 4. A random forest plot of the association between fear and study group (control vs virtual reality) [34,40,43,47,51]. Buzzy: a device that applies local cold and vibration at the injection site; DC: distraction card; IV: inverse variance; VR: virtual reality. difficult to compare these results with those of other studies Discussion because most of them included different medical processes or did not analyze the effect on the children’s fear. However, other To the best of our knowledge, this is the first systematic review meta-analyses found similar results, indicating that the effects with a meta-analysis designed to examine the effectiveness of of VR are beneficial in reducing fear during medical processes the use of VR as a distraction measure to reduce pain and fear involving pain, especially in children [54]. However, these in the pediatric population during procedures involving needles. comparisons must be analyzed with caution because neither the Based on the high effect sizes that we found, our results suggest studies included nor their participants were homogeneous in that VR distraction is possibly more effective than the habitual terms of age or characteristics, the medical procedures analyzed, routine or other distractions used during needle procedures to or the tools used to measure pain. reduce the perception of pain and fear felt by children. It is https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al Most of the papers included in this review found that VR had low. However, some studies with low quality or even small a positive effect by helping to reduce pain in children. Of note, samples showed important effects. We assume that in the future, all the studies that had included more than 100 participants and a meta-regression model could be used to expand existing had used the Wong-Baker Faces Pain Rating Scale (WBFPS) knowledge about these intervention types and their had reported statistically significant results. This may be because methodological quality. For this reason, this systematic review this visual assessment scale is more effective in assessing pain and meta-analysis highlights the need to design and implement in children than other scales that use numerical assessment new research with high methodological quality that would allow scales such as the visual analog scale (VAS) for pain [55]. extraneous variables to be isolated, favoring the cause-effect Although the VAS is a reliable method for assessing acute pain, relationship. The principal reasons for the studies included in children younger than 7 years may have difficulty in its use, as this meta-analysis to be of low quality were that it was nearly indicated by the reduced reliability of the results reported in impossible to blind both the participants and health care these studies [56]. In addition, the VAS and WBFPS have been personnel to the VR intervention because of the nature of these widely used in studies evaluating pain in other procedures such devices [76]. Furthermore, in many cases, the absence of as wound healing [57], physiotherapy sessions after complex randomization was justified for ethical reasons. Indeed, more surgical interventions [58], or dental procedures [59] in which than half of the studies we examined had considered small they produced positive results. sample sizes of fewer than 100 participants [77], which, in addition to being unreliable and inefficient, can lead to Most of the papers included in this review overestimation of the study effect size and can produce low [32,33,35,37-41,44,45,47-52] had analyzed the effect of VR on reproducibility of the results. Finally, chronological age and pain and fear in pediatric patients with cancer during neurological development are among the factors that influenced venipuncture or reservoir puncture procedures. Furthermore, children’s perceptions of pain and fear of procedures involving most of the studies we retrieved (20/21, 95%) had been carried needles, and therefore, adjusting the age of children to less than out in hospitals, while only 5% (1/21) had been carried out in 21 years should be considered in future studies [78]. Blinding primary health care centers. This may have been a result of the and randomization are also the issues that were identified in the health care provision resources available at the sites where these risk of bias analysis of studies not included in the meta-analysis. previous studies had been carried out, given that most of this The studies included in the meta-analysis generally had a low work had been carried out in hospitals, thanks to the teaching level of risk, while studies not included tended to have a higher function of these centers [60-62]. These data indicate that scant level of risk of bias. This may be due both to the fact that research has been carried out for this level of care, which is meta-analysis studies are more robust and to the use of different surprising, considering that needle procedures are frequent in measurement tools in these papers. primary care contexts because of the systematic vaccination programs carried out in the pediatric population. Among other The main limitations of this work were, on the one hand, the possible explanations, perhaps this lack of research can be lack of studies with nonsignificant results available in the explained by health care staff overload or low levels of scientific literature. This meant that we may not have included motivation among professionals or toward the support of all the relevant studies, and therefore, it was not possible to research [63-67]. However, 2 study protocols have recently control for publication bias [79]. On the other hand, although been published that will aim to evaluate the effectiveness of the random effects model that we used favored the most realistic VR against pain during vaccination in the pediatric population observation of the data by specifically weighting each study, through RCTs with estimated sample sizes of 100 [68] to more the heterogeneity of the included studies, both in terms of their than 400 participants [69]. outcome measures and their methodological approaches, means that we must be cautious about the interpretation of our results. Although we found that VR is effective in reducing children’s This problem was also identified in a similar recent fear, very few studies have demonstrated the usefulness of VR meta-analysis in which heterogeneity was found in studies with in reducing fear during procedures involving needles [40,47]. young patients [54]. Finally, the studies included did not address Thus, the absence of a validated scale to measure this variable the effect of VR in children younger than 4 years, which implies may be inhibiting its proper evaluation [70]. According to a limitation of the results when it comes to generalizing this Taddio et al [71], most studies that measure fear do so by using effect in all children. Based on all the above, the methodological questionnaires developed by the investigators, nonvalidated design of future work must adequately calculate the required scales, or scales for measuring anxiety [72,73]. Thus, this review sample sizes and use appropriate sampling, participant study reveals the lack of consensus on the most appropriate group allocations, and blinding techniques to be able to instruments for evaluating and clearly differentiating between extrapolate any data obtained to the wider pediatric population. fear and distress in the pediatric population. Although in clinical This review was limited by the quality of the studies it included. practice, the difference between fear, anxiety, and stress may Generalization of these findings to younger children should also not always be relevant, these represent different theoretical be done with caution because the studies we considered had not constructs, which are not always rigorously differentiated. included children younger than 4 years. Notwithstanding, both fear and distress are important factors that are related to and impact the pain perceived by children In conclusion, the findings of this review indicate that VR could [74,75]. be a feasible distraction measure to reduce the perception of pain and fear in the pediatric population during procedures Of note, the quality of the studies included in this systematic involving needles. However, these results are limited by the review (based on CASPe and Jadad assessments) was mostly https://games.jmir.org/2022/3/e35008 JMIR Serious Games 2022 | vol. 10 | iss. 3 | e35008 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR SERIOUS GAMES Lluesma-Vidal et al heterogeneity of the studies included. In this sense, more trials will be needed in the future. with larger sample sizes and quality methodological techniques Acknowledgments This work was supported by a grant from the University CEU Cardenal Herrera (ICLINIC/1906).  Authors' Contributions MLV and CRZ conceptualized and designed the study, drafted the initial manuscript, designed the data collection instruments, and reviewed the manuscript. RCG collected the data, carried out the analysis, and revised the manuscript. LP drafted the initial manuscript. LGG and MISL critically reviewed the manuscript for important intellectual content. All the authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. Conflicts of Interest None declared. Multimedia Appendix 1 Search strategies. [DOC File , 33 KB-Multimedia Appendix 1] Multimedia Appendix 2 General characteristics and results of the studies in this review. [DOC File , 211 KB-Multimedia Appendix 2] Multimedia Appendix 3 Evaluation of the methodological quality. [DOC File , 77 KB-Multimedia Appendix 3] Multimedia Appendix 4 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) checklist. [DOC File , 88 KB-Multimedia Appendix 4] Multimedia Appendix 5 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis)_2020_Abstract_checklist. [DOC File , 48 KB-Multimedia Appendix 5] References 1. Hoffman HG. Virtual-reality therapy. Sci Am 2004 Aug;291(2):58-65. [doi: 10.1038/scientificamerican0804-58] [Medline: 15298120] 2. Hedén L, von Essen L, Ljungman G. 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[doi: 10.1002/14651858.MR000006.pub3] [Medline: 19160345] Abbreviations CASPe: Critical Appraisal Skills Program guide in Spanish IV: inverse variance RCT: randomized controlled trial VAS: visual analog scale VR: virtual reality WBFPS: Wong-Baker Faces Pain Rating Scale Edited by N Zary; submitted 19.11.21; peer-reviewed by B Nievas Soriano, KA Nguyen; comments to author 22.01.22; revised version received 19.03.22; accepted 13.05.22; published 09.08.22 Please cite as: Lluesma-Vidal M, Carcelén González R, García-Garcés L, Sánchez-López MI, Peyro L, Ruiz-Zaldibar C JMIR Serious Games 2022;10(3):e35008 URL: https://games.jmir.org/2022/3/e35008 doi: 10.2196/35008 PMID: ©Marta Lluesma-Vidal, Raquel Carcelén González, Laura García-Garcés, María I Sánchez-López, Loreto Peyro, Cayetana Ruiz-Zaldibar. Originally published in JMIR Serious Games (https://games.jmir.org), 09.08.2022. 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Published: Aug 9, 2022

Keywords: virtual reality; pain; fear; pediatric; needle; child; injection; VR; systematic review; meta-analysis; paediatric

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