Adjunctive virtual reality pain relief following traumatic injury: protocol for a randomised within-subjects clinical trial

Ryan B Felix, Aniruddha Rao, Mazhar Khalid, Yang Wang, Luana Colloca, Sarah B Murthi, Nicholas A Morris, Ryan B Felix, Aniruddha Rao, Mazhar Khalid, Yang Wang, Luana Colloca, Sarah B Murthi, Nicholas A Morris

Abstract

Introduction: The annual mortality and national expense of the opioid crisis continue to rise in the USA (130 deaths/day, $50 billion/year). Opioid use disorder usually starts with the prescription of opioids for a medical condition. Its risk is associated with greater pain intensity and coping strategies characterised by pain catastrophising. Non-pharmacological analgesics in the hospital setting are critical to abate the opioid epidemic. One promising intervention is virtual reality (VR) therapy. It has performed well as a distraction tool and pain modifier during medical procedures; however, little is known about VR in the acute pain setting following traumatic injury. Furthermore, no studies have investigated VR in the setting of traumatic brain injury (TBI). This study aims to establish the safety and effect of VR therapy in the inpatient setting for acute traumatic injuries, including TBI.

Methods and analysis: In this randomised within-subjects clinical study, immersive VR therapy will be compared with two controls in patients with traumatic injury, including TBI. Affective measures including pain catastrophising, trait anxiety and depression will be captured prior to beginning sessions. Before and after each session, we will capture pain intensity and unpleasantness, additional affective measures and physiological measures associated with pain response, such as heart rate and variability, pupillometry and respiratory rate. The primary outcome is the change in pain intensity of the VR session compared with controls.

Ethics and dissemination: Dissemination of this protocol will allow researchers and funding bodies to stay abreast in their fields through exposure to research not otherwise widely publicised. Study protocols are compliant with federal regulation and University of Maryland Baltimore's Human Research Protections and Institutional Review Board (protocol number HP-00090603). Study results will be published on completion of enrolment and analysis, and deidentified data can be shared by request to the corresponding author.

Trial registration number: NCT04356963; Pre-results.

Keywords: clinical trials; neurological injury; neurological pain; pain management; trauma management.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow sheet. GCS, Glasgow Coma Score; HADS, Hospital Anxiety and Depression Survey; MISS, Multidimensional Iowa Suggestibility Scale; MSBS, Multidimensional State Boredom Scale; ORT, Opioid Risk Tool; PCS, Pain Catastrophizing Scale; SOAPP-R, Screener and Opioid Assessment for Patients with Pain- Revised; VR, virtual reality
Figure 2
Figure 2
Study participant performing virtual reality therapy session.

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