BackgroundIn-office procedures can be painful and anxiety-provoking for pediatric patients. Minimizing such pain and anxiety in children improves the patient experience and promotes a rewarding and productive patient-caregiver-provider relationship, which may for some young patients be their first memorable encounter with the healthcare system. Although virtual reality (VR) techniques have proven to be helpful in minimizing pain and anxiety during procedures in pediatric intensive care settings, it remains unclear how VR affects objective and subjective measures of pain and anxiety in children undergoing in-office orthopaedic procedures such as cast removal or percutaneous pin removal after fracture healing.Questions/purposesIs a VR gaming simulation more effective than either of two forms of noninteractive visual distraction (VR goggles or tablet computer displaying a noninteractive video) for reducing (1) objective measures of pain and anxiety and (2) subjective measures of pain and anxiety in children undergoing in-office cast removal or percutaneous pin removal?MethodsThis study was a randomized controlled trial with two parallel, separately analyzed cohorts: children undergoing in-office cast removal or in-office percutaneous pin removal at a single urban tertiary institution. We approached eligible patients who were scheduled to undergo outpatient cast or percutaneous pin removal and who met prespecified inclusion criteria. We enrolled until 105 patients were available for analysis in each of the cast removal and pin removal cohorts. Of note, the study institution was in an urban epicenter of the coronavirus-19 pandemic, and clinical research was paused sporadically, which resulted in a longer-than-expected enrollment period. In the cast removal cohort, all patients were eligible for inclusion and were enrolled and randomized into one of three groups: VR gaming simulation (n = 37), VR goggles with a noninteractive video (n = 36), or a tablet computer with the same noninteractive video (n = 40). Eleven percent (4), 8% (3), and 3% (1) withdrew from each of the three intervention groups, respectively. In the pin removal cohort, all patients were eligible for inclusion and were enrolled and randomized into the same three groups (37, 44, and 41 patients, respectively). In the pin removal group, 14% (5), 18% (8), and 10% (4) withdrew from each of the three intervention groups, respectively. In all, 235 patients were enrolled in the study and 210 patients (mean +/- SD age 9 +/- 3 years; 48% [100] girls) were included in the final analyses. There were no clinically important differences in age, gender, preprocedure pain, or anxiety among the intervention groups. Primary outcomes included preprocedure-to-maximum heart rate increase (objective measure) and preprocedure and postprocedure pain and anxiety using a VAS (subjective measures). One-way ANOVA and Bonferroni-adjusted pairwise comparisons were used to calculate between-group differences for the primary outcomes.ResultsThere were no intervention-level groupwise differences between VR goggles with an interactive game, VR goggles with a noninteractive video, or the tablet computer with the same video in preprocedure-to-maximum heart rate increase in the cast removal cohort (18 +/- 21 bpm versus 14 +/- 11 bpm versus 20 +/- 16 bpm, respectively; largest mean difference -6 bpm [95% CI -16 to 3]; p = 0. 36) or pin removal cohort (27 +/- 20 bpm versus 23 +/- 12 bpm versus 24 +/- 19 bpm, respectively; largest mean difference 4 bpm [95% CI -7 to 14]; p = 0.99). Similarly, there were no intervention-level groupwise differences in preprocedure to postprocedure VAS pain in the cast removal cohort (1 +/- 1 versus 1 +/- 2 versus 0 +/- 2, respectively; largest mean difference 0 points [95% CI 0 to 1]; p = 0.89) or pin removal cohort (0 +/- 3 versus 2 +/- 3 versus 0 +/- 3 points, respectively; largest mean difference 1 point [95% CI 0 to 3]; p = 0.13). Finally, there were no intervention-level groupwise differences between the same intervention groups in preprocedure to postprocedure VAS anxiety in the cast removal cohort (-2 +/- 2 versus -1 +/- 2 versus -1 +/- 2 points, respectively; largest mean difference -1 point [95% CI -2 to 1]; p = 0.63) or pin removal cohort (-3 +/- 3 versus -4 +/- 4 versus -3 +/- 3 points, respectively; largest mean difference -1 point [95% CI -2 to 1]; p = 0.99).ConclusionDuring in-office cast and pin removal in pediatric patients, simple distraction techniques such as tablet video viewing are as effective as higher-fidelity VR headset video and interactive games in minimizing objective measures of procedural pain and subjective measures of pain and anxiety. Because of these findings and because of the associated costs, implementation logistics, and variable tolerance by young patients, widespread use of VR distraction techniques in the pediatric orthopaedic outpatient setting is unnecessary.Level of EvidenceLevel I, therapeutic study.
