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

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.

Adjunctive virtual reality pain relief after traumatic injury: a proof-of-concept within-person randomized trial

“…The study design and protocol have been previously published. 10 In brief, we conducted a randomized within-subject crossover clinical trial comparing the effects of an immersive VR environment against 2 control interventions. One control consisted of identical content to the immersive VR environment presented on a nonimmersive electronic tablet to control for immersion effects.…”

Effects of virtual reality OSCE on nursing students’ education: a study protocol for systematic review and meta-analysis

“…4 The exam station is divided into long and short stations, with a duration ranging from 5 min to 20 min; candidates are evaluated by the examiner or SP. 5 However, given that the OSCE requires a person-in-person offline operation, some objective factors, such as the restrictions of the COVID-19 epidemic some time ago, [6][7][8] the development of virtual reality (VR) technology in the field of nursing education, [9][10][11] and the increasingly popular cross-regional and multicentre joint training, 12 13 exist. As a result, the traditional offline OSCE cannot satisfy the requirements of modern nursing education.…”