Abstract
BACKGROUND: Cast removal may produce pain or anxiety in children. Virtual reality (VR) has been studied in other pediatric settings, but little evidence exists for its use during pediatric cast removal. METHODS: A randomized controlled trial was performed in children aged 4 to 12 years, assessing the effect of VR compared with standard of care (SOC) on pain and anxiety during first-time cast removal. Children were randomized to SOC earmuffs or a VR headset. VR was hypothesized to produce less sympathetic response, lower pain, and less anxiety. Metrics were assessed by a standardized protocol. Primary aim: sympathetic response as measured by continuous heart rate (HR) before, during, and after cast removal. Secondary aims: pain as assessed using the FACES (0-10) and Visual Analog Scale (VAS; 0-100) score, and anxiety as assessed by the VAS score (0-100). RESULTS: Ninety patients were analyzed in each of the SOC and VR groups for the primary outcome. The average age was 7.84 years (range 4-12). There were no differences in sympathetic response by baseline, removal, or change in HR between groups (+11.23 bpm for SOC vs. + 7.84 bpm for VR, p = 0.113). There were no differences in baseline, removal, or change in pain (FACES +0.86 for SOC vs. + 0.40 for VR, p = 0.220). Most patients and caregivers reported no pain, and average FACES scores were low (1.45 for SOC and 1.00 for VR). VR improved child anxiety (-4.31 ± 22.6 for VR vs. 9.96 ± 33.94 for SOC, p = 0.001) and caregiver anxiety (-17.12 ± 25.78 for VR vs. -4.99 ± 29.03 for SOC). There was high caregiver satisfaction with the removal experience in both groups (95.34 ± 15.39 in SOC vs. 95.40 ± 15.48 in VR, on a VAS 0-100). CONCLUSIONS: Use of VR did not improve sympathetic response or self-reported pain during pediatric cast removal compared with SOC. Pain during pediatric cast removal was uniformly low. Child and caregiver anxiety was improved by the use of VR. LEVEL OF EVIDENCE: Level I-randomized controlled trial. See Instructions for Authors for a complete description of levels of evidence.