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Pilot Randomized Clinical Trial of Virtual Reality Pain Management During Adult Burn Dressing Changes: Lessons Learned

Megan Armstrong, Rebecca Coffey, John Luna, Henry Xiang

Abstract

Opioids 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 in 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.

Introduction

Burn injuries affect millions of individuals around the world [1]. There were an estimated 204,319 nonfatal burn injuries (about 82 per 100,000) among US adults in 2020 [2]. For moderate to severe burns, daily dressing changes are required, which are very painful and often require high-dose opioids. A 2016 survey by Meyers et al. of 378 nurses and physicians from 133 American Burn Association Burn Centers reported that for burn dressing changes, oxycodone, morphine, or fentanyl are the most frequently used opioid medications, respectively [3]. This is particularly concerning due to the current opioid epidemic [4]. Meyers et al’s 2016 study found that 80% of respondents reported that procedural burn pain could be more adequately controlled [3].

Materials and method

This three-group pilot randomized clinical trial (RCT) was designed to test feasibility and efficacy of a smartphone VR-PAT in reducing self-reported and observed pain of adult burn injury patients during repeated inpatient dressing changes. Adult patients with burn injuries were recruited between May 2019 and February 2020 from an American Burn Association-verified Burn Center and randomly allocated to one of three treatment arms: active VR, passive VR, or a standard of care. Eligible subjects were 1) 18–70 years of age (inclusive), 2) their first admission for this acute burn injury, 3) require dressing changes, 4) using opioids for dressing changes, and 5) whose burn is ≤4 days from their burn injury. Patients were excluded if they had 1) severe burn(s) on the face/head preventing utilization of VR, 2) cognitive/motor impairment preventing valid administration of study measures, 3) unable to communicate in English, 4) prisoners and patients who were pregnant, and 5) patients admitted to the intensive care unit.

Results

Of the 14 participants in this study, they were a median 38.4 years of age, mostly male (71.4%), and White (85.7%) (Table 1). Burn injuries varied from 1.0 to 17.8% TBSA (median 8.4%) and the largest proportion of the burns were partial thickness (median TBSA = 8.4%). The largest full thickness burn was 3.0% TBSA.

Discussion

This pilot RCT study showed some promising results of using VR for pain management during adult burn dressing changes. While this study had a small sample size caused by the patient recruitment interruption due to COVID-19, the preliminary results suggest that patients in the active VR group experienced less pain than those in the passive VR and control groups. More importantly, this pilot study had many lessons that could be important to other researchers who plan to design future adult VR pain management studies.

Conclusions

VR is a useful non-pharmacological tool for pain distraction but designing and implementing clinical research studies can face many challenges in the real-world medical settings. Future studies should consider these challenges when working with adult burn patients and work closely with clinic staff and patients to pilot test study protocols before launching a full-scale VR intervention study.

Acknowledgments

We appreciate Mr. Jonathan Lun for his assistance with the literature review for this project as a summer intern.

Citation: Armstrong M, Coffey R, Luna J, Xiang H (2023) Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: Lessons learned. PLOS Digit Health 2(9): e0000231. https://doi.org/10.1371/journal.pdig.0000231

Editor: Ismini Lourentzou, Virginia Tech: Virginia Polytechnic Institute and State University, UNITED STATES

Received: March 15, 2023; Accepted: August 7, 2023; Published: September 25, 2023

Copyright: © 2023 Armstrong et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: The data for this manuscript was obtained from electronic medical records and contain patient data from a burn injury admission from a single medical institution. Because burn injury admissions are a rare enough event, knowing the medical center and date range could potentially identify a patient even with efforts to de-identify data. This data was also collected under a data use agreement, so all requests need to be reviewed to ensure all data sharing requirements are being met. To request access to the research data, please contact the Data Trust & Value Committee at Nationwide Children’s Hospital via e-mail at datatrustcmt@nationwidechildrens.org. De-identified data will be provided via a Microsoft Excel file.

Funding: This work was supported by the Ohio Innovation Fund (HX) and the Agency for Healthcare Research and Quality (R01HS29183-01 to HX and RC). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

 

https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000231#ack

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