Feasibility and Acceptability of Perioperative Application of Biofeedback-Based Virtual Reality vs Control for Pain and Anxiety in Children and Adolescents Undergoing Surgery: Pilot Randomized Controlled Trial

Abstract Background The impact of biofeedback-based virtual reality (VR-BF) on pain and anxiety in pediatric surgical patients remains unexplored. Objective The objective of this study was to evaluate the feasibility and acceptability of perioperative VR-BF use in children and adolescents. Methods We performed a single-blind, 2-arm, randomized pilot trial. Children aged 12 to 18 years undergoing surgery with expected moderate-to-severe postoperative pain and more than 1 overnight admission were randomized (1:1) to the intervention or control group. Participants in the intervention group received VR-BF using ForeVR (functional outcome response to engaging virtual reality [VR]), a novel, gamified digital intervention that integrates respiratory biofeedback into an immersive VR environment to train children in vagal tone modulation, and the control group used Manage My Pain , an app designed to assist patients with recognizing and reflecting on their pain. Participants and caregivers were unblinded to their assigned intervention but blinded to the other arm’s technology; data analysts were masked to treatment allocation. The primary outcome was feasibility, assessed through recruitment, enrollment and randomization, retention, adherence, and outcome data collection. Secondary outcomes evaluated acceptability, including satisfaction and tolerability. Exploratory outcomes, including pain intensity, pain unpleasantness, and anxiety, were assessed in the VR-BF group. This trial was registered at ClinicalTrials.gov (NCT04943874) and is complete. Results Of the 202 patients who were eligible for study participation, 70 were enrolled, and 65 (92.9%) patients completed the study (VR-BF, n=30; control, n=35). Female participants accounted for 41 (58.6%) of the participants, and the median age of participants was 16.2 (IQR 14.1-17.5) years. VR-BF participants completed a median of 4 (IQR 3-5) preoperative training sessions and 7 (IQR 2-9) postoperative sessions. Acceptability was high; only 2 (6.7%) would not use VR-BF again. Six VR-BF patients reported mild, transient adverse events (AEs), none of which were serious. VR-BF patients with baseline pain and anxiety scores ≥ 2 reported a median 1-point (IQR 0-2) reduction in pain intensity, unpleasantness, and anxiety immediately and up to 30 minutes postsession. Conclusions Perioperative use of VR-BF is feasible and acceptable in pediatric surgical patients, with high recruitment, retention, and satisfaction and no serious AEs. These findings support a subsequent trial to assess the efficacy and long-term impact of this novel technology.