RESUMEN
BACKGROUND: Biofeedback-based virtual reality (VR-BF) is a novel, nonpharmacologic method for teaching patients how to control their breathing, which in turn increases heart rate variability (HRV) and may reduce pain. Unlike traditional forms of biofeedback (BF), VR-BF is delivered through a gamified virtual reality environment, increasing the accessibility of BF. This is the first study to systematically integrate VR-BF use in the pediatric perioperative setting, with the ultimate goal of evaluating the efficacy of VR-BF to reduce pain, anxiety, and opioid consumption once feasibility and acceptability has been established. OBJECTIVE: The primary objective was to develop a clinical trial protocol for VR-BF use in the pediatric perioperative setting, including preoperative education/training and postoperative application of VR-BF in children undergoing surgery. A secondary objective was to evaluate the patient/parent experience with VR-BF. 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 training, participants independently completed a daily, 10-minute VR-BF session for seven days before surgery and during their inpatient stay. Participants could use 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 identify the optimal frequency and duration of sessions before and after surgery for this population. Standardized questionnaires and semi-structured interviews were conducted to obtain qualitative information about patients' experiences with VR-BF. RESULTS: Patient-level data indicated that the highest odds of achieving ï³1 session under target HRV parameters was 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 of 9 to 10 minutes provided the greatest odds of achieving ï³1 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: Children and adolescents undergoing surgery successfully learned behavioral strategies with VR-BF with once-daily 10-minute sessions for 5 days. To integrate VR-BF as a therapeutic intervention in a subsequent clinical trial, 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.
