Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: lessons learned

Abstract

AbstractOpioids are the most frequently used pain medications by US burn centers to control severe procedural pain during wound care. Concerns for long-term opioid use have prompted the exploration of non-pharmaceutical interventions, such as virtual reality (VR), for procedural pain management. The primary objective of this pilot study was to evaluate the feasibility and efficacy of VR pain alleviation treatment on reducing adult burn patients’ perceived pain during burn dressing changes. Adult patients aged 18-70 years were recruited from the inpatient unit of a single American Burn Association–verified burn center between May 2019 and February 2020 and randomly assigned to one of three arms. Active VR participants played four VR games; passive VR participants were immersed in the same VR environment without the interaction elements; and a standard of care control group. 71 patients were screened for eligibility and 33 were deemed eligible to approach for informed consent, with 14 agreeing to participate in this study. Of these 14 patients, 4 were randomly assigned to the active VR, 4 to the passive VR, and 6 to the control group. Self-reported overall pain was lowest among participant in the active VR (dressing 1= 41.3, dressing 2= 61.0, and dressing 3= 72.7) and highest among participants in the passive VR (dressing 1= 58.3, dressing 2= 74.5, and dressing 3= 89.0) across all three dressing changes. Self-reported worst pain was lowest among the active VR at the first and last dressing (64.3 and 92.2, respectively), but the control group has the lowest self-reported worst pain at the second dressing (71.3). VR is a useful non-pharmacological tool for pain distraction but designing and implementing clinical research studies face many challenges in real-world medical settings. Lessons from this study have important implications for future VR studies by other researchers.Trial RegistrationClinicalTrials.govIdentifier:NCT04545229Author SummaryIn this paper we describe our experience conducting a randomized clinical trial using virtual reality as a pain distraction during inpatient burn care. This pilot study was designed to evaluate feasibility and efficacy of virtual reality as a pain distraction treatment. Three groups intervention groups were compared across multiple burn care procedures. We enrolled 14 patients across 10 months of recruitment. While our sample size was too small to consider significance testing, we did find that the group with active virtual reality participation reported less pain than those in the other two groups. We documented many challenges with using virtual reality during burn dressing changes, including the severity of injuries and the need for high-dose opioids, lack for interest in virtual reality, the unique nature of inpatient wound care, and methods of interacting with a game. COVID-19 also created recruitment restriction for our study. We proposed methods for circumventing these challenges for future researchers when designing virtual reality studies among adult patients.