JMIR Publications

ABSTRACT

Background:

The impact of biofeedback-based virtual reality (VR-BF) on pain and opioid use 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, two-arm, randomized pilot trial. Children 12-18 years undergoing surgery with expected moderate-to-severe postoperative pain and >1 overnight admission were randomized (1:1) to intervention or control. Intervention patients received VR-BF using ForeVR, a novel, gamified digital therapeutic that integrates respiratory biofeedback into an immersive VR environment to train children in vagal tone modulation, and controls 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 analysists were masked to treatment allocation. The primary outcome was feasibility (recruitment, retention, outcome data collection). Secondary outcomes assessed acceptability (satisfaction, usability, safety) and exploratory measures of outcome (pain intensity, pain unpleasantness, anxiety). This trial was registered on ClinicalTrials.gov (NCT04943874) and is complete.

Results:

Of the 202 patients who were eligible, 70 were enrolled and 65 completed the study (92.9%; VRBF, n=30; control, n=35). 41 (58.6%) were women, and the median age of participants was 16.2 years [IQR 25th, 75th [14.1, 17.5]. VR-BF participants completed a median of 4 preoperative [3, 5] and 7 postoperative [2, 9] sessions. Acceptability was high; only two (6.7%) would not use VR-BF again. Six patients reported mild, transient adverse events (AEs), none of which were serious. VR-BF patients with baseline pain/anxiety scores >2 reported a median 1-point reduction in pain intensity, unpleasantness, and anxiety immediately and up to 30-minutes post-session.

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 efficacy and long-term impact. Clinical Trial: ClinicalTrials.gov (Identifier: NCT04943874)