NCT04356963

Adjunct VR Pain Management in Acute Brain Injury

Adjunct Virtual Reality Pain Management in Acute Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Severe and refractory pain after acute injury is a known-risk factor for chronic opioid use disorder. In this study, the investigators will use Virtual Reality (VR) immersion as a non-pharmacological adjunct to treat pain associated with acute traumatic injuries, including traumatic brain injury. The investigators hypothesize that VR therapy will decrease pain and reduce opioid use in patients with acute traumatic injuries, including TBI.

Detailed description

Each participant will undergo one VR session and two control sessions. The VR session will take place in a commercially available VR environment, the Blu, and last 20-30 minutes (VR Blu). The control sessions will include a 2D-tablet based session that mimics the VR content (Tablet Blu) and a content-less placement of the VR headset (VR Blank). The order of these sessions will be randomized across participants are intended to complete all sessions. Each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addiction/engagement, boredom, and expectancy. These scales will help us determine which patient-level factors predict response to VR. Before and after each session, participants will complete validated scales of pain, nausea, and anxiety.. Pre- and Post-VR opioid use will be recorded. Basic vital signs including heart rate, blood pressure, and respiratory rate, will be recorded before and after each session to monitor autonomic response. Advanced measures of autonomic response will include heart rate variability,,and pupillometry metrics. At the conclusion of all sessions, participants will complete another questionnaire to document their subjective experience of using VR (perceived effectiveness)

Conditions

• Traumatic Brain Injury
• Headaches Posttraumatic
• Trauma
• Pain, Acute

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Reality Session (VR Blu)	20-30 minute session of virtual reality immersive content.
BEHAVIORAL	Tablet-based Session (Tablet Blu)	20-30 minute session of tablet-based content that mimics the content from virtual reality sessions.
BEHAVIORAL	Use of Virtual Reality Head Mounted Display without Content (VR Blank)	20-30 minutes session using head mounted display to reduce light and sound.

Timeline

• Start date: 2020-09-05
• Primary completion: 2022-01-07
• Completion: 2022-04-30
• First posted: 2020-04-22
• Last updated: 2023-04-24
• Results posted: 2023-04-24

Locations

2 sites across 1 country: United States