A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition

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Pain management is a top priority during pediatric burn dressing changes. Although virtual reality (VR) for pain management during burn care has been studied in clinical trials for more than 2 decades, there is still no evidence of the effectiveness of smartphone VR for pain management during the care transition from medical settings to at-home burn care. This study’s long-term goal is to use innovative, patient-centric smartphone VR to improve patient experience and outcomes. Based on our published findings that our innovative VR Pain Alleviation Tool (VR-PAT) could result in a clinically meaningful reduction in pain (47.1% overall pain reduction) among 90 pediatric burn patients treated at our hospital outpatient clinic, the overall objectives are to (i) determine VR-PAT effectiveness for pain management and opioid medication use reduction during at-home burn care, and (ii) to identify potential facilitators and barriers that could affect wide use of VR-PAT. The central hypothesis is that VR-PAT can induce clinically meaningful pain reduction (>30%) during repeated at-home burn dressing changes. The rationale is that a determination of the VR-PAT effectiveness at reducing pain and opioid medication use, safety, and patient/family engagement is likely to offer a strong scientific framework by which a smartphone VR can be implemented widely and easily by families at-home. Two specific aims : 1) Evaluate effectiveness of VR- PAT for pain management and opioid pain medication reduction during at-home burn care; 2) Examine continuous engagement of patients and caregivers with VR-PAT during repeated at-home burn dressing changes. A two-group randomized clinical trial will be implemented among a total of 200 pediatric burn patients (6-17 years old). Patients and caregivers from both the intervention group (VR-PAT) and control group (standard care) will complete their daily burn dressing changes at home. Overall pain and worst pain will be measured using a standardized pain Visual Analogue Scale (VAS) during each burn dressing change for 1 week. Area under the curve for child reported overall pain (AUC-VAS) and morphine equivalent total dose of pain medications (AUC-OC) will be integrated to calculate composite pain score intensity and opioid consumption (PIOC) score as the primary outcome for Aim 1. For Aim 2, adverse events, VR experience and engagement will be measured in the VR group to specifically address challenges in designing mHealth interventions that the U.S. National Academy of Medicine (NAM) identified as needing more research. This project is innovative because it not only tests an innovative smartphone VR to optimize patient’s experience and outcomes during at- home care but will also develop a novel composite pain assessment statistical method for broader burn research. The proposed research is significant because it is expected to provide strong scientific as well as practical justifications for implementing smartphone VR for pain management during at-home burn care. Ultimately, such knowledge has the potential of offering smartphone VR as an effective and safe non-pharmaceutical pain management approach during care transition from medical settings to at-home care by family caregivers.