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

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 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ClinicalTrials.gov Identifier: NCT04545229

Funding Statement

Funding/Support: This project is supported in part by funding from the Ohio Innovation Fund (Xiang – Principal Investigator (PI) and the Agency for Healthcare Research and Quality (R01HS29183-01, Xiang-PI). Role of the Funder/Sponsor: The funding source had no role in designing the study, collecting the data, managing the study, interpreting the data, preparing, reviewing, or approving the manuscript, or deciding to submit the manuscript for publication.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The institutional review board of The Ohio State University reviewed and approved this study. Written informed consent was collected from each patient prior to participation in the study.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

Even upon de-identifying this human subjects data, it is possible that subjects could be identified due to the small sample size and the one recruitment location. Data cannot be publicly shared, but data sets can be made available upon request

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