Feasibility and Acceptability of Biofeedback-Based Virtual Reality for Acute Postoperative Pain and Anxiety Reduction in Children and Adolescents: Phase 1 of a Pilot Observational Study (Preprint)

Abstract

BACKGROUND Biofeedback-based virtual reality (VR-BF) is a novel, nonpharmacologic method for teaching patients how to control their breathing, which in turn increases their heart rate variability (HRV) and reduces pain. Unlike traditional forms of biofeedback (BF), VR-BF is delivered through a gamified virtual reality (VR) environment, increasing the accessibility and pain-relieving benefits of BF. This is the first study to systematically integrate VR-BF in perioperative management in children and adolescents, with the ultimate goal of evaluating the efficacy of VR-BF to reduce pain, anxiety, and opioid consumption in a subsequent clinical trial once the feasibility and acceptability of this technology have been established. OBJECTIVE The primary objective was to develop a clinical trial protocol for VR-BF, encompassing the preoperative education and training and the postoperative application of VR-BF in children undergoing surgery. A secondary objective was to evaluate the patient experience with VR-BF based on self-report. METHODS A total of 23 patients (12-18 years of age) scheduled for surgery at Nationwide Children's Hospital were recruited using purposive sampling. Following an in-person or virtual training session to learn how to use the equipment and understand the concepts of BF, participants were instructed to independently complete a daily, 10-minute VR-BF session for seven days before surgery and during their inpatient stay. Participants had the option to continue using VR-BF up to two weeks after hospital discharge. Patient and session–level data of VR-BF usage and achievement of target HRV parameters were measured to refine a treatment protocol, including the optimal frequency and duration of sessions before and after surgery for this population. Standardized questionnaires and semi-structured interviews were conducted to obtain additional qualitative information about the patients’ experiences with VR-BF. RESULTS Patient-level data indicated that the highest odds of achieving at least 1 session under target HRV parameters were observed after 4 sessions (OR 4 vs. 3 sessions=5.1, 95% CI 1.3-20.6; OR 3 vs. 2 sessions=16.6, 95% CI 1.2-217.0). Session-level data showed that a session duration between 9 to 10 minutes provided patients the greatest odds of achieving at least 1 session under target HRV parameters (OR 9 vs. 8 minutes=1.3, 95% CI 1.1-1.7; OR 8 vs. 7 minutes=1.4, 95% CI 1.1-1.8; OR 10 vs. 9 minutes=1.0, 95% CI 0.9-1.2). Qualitative data revealed patient satisfaction with the VR-BF technology, particularly in managing perioperative stress (n=17, 85%). Few patients reported VR-BF as beneficial for pain (n=8, 40%). CONCLUSIONS For children and adolescents to independently learn behavioral strategies shown to provide pain relief with VR-BF, the current study recommends that patients use once-daily 10-minute sessions for 5 days leading up to the surgery date. To integrate VR-BF as a therapeutic intervention, patients will be instructed to complete three 10-minute sessions a day for 7 days after surgery. CLINICALTRIAL ClinicalTrials.gov; NCT04943874; https://clinicaltrials.gov/ct2/show/NCT04943874