Trial reportJournal of medical Internet research2026
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.
Trial report in Journal of medical Internet research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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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 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.
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