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Clinical Trials/NCT04356963
NCT04356963
Completed
Not Applicable

Adjunct Virtual Reality Pain Management in Acute Brain Injury

University of Maryland, Baltimore2 sites in 1 country60 target enrollmentSeptember 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
University of Maryland, Baltimore
Enrollment
60
Locations
2
Primary Endpoint
Change in Pain Score
Status
Completed
Last Updated
3 years ago

Overview

Brief 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)

Registry
clinicaltrials.gov
Start Date
September 5, 2020
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicholas Morris

Assistant Professor of Neurology

University of Maryland, Baltimore

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Traumatic Injury (including but not limited to traumatic brain injury)
  • Age greater than or equal to 18 years-old
  • Endorsing at least moderate pain as defined by documentation of at least one numeric rating pain scale score of 3 or more in the last 24 hours.
  • Glasgow Coma Scale of 15
  • Expected to stay in the hospital for at least 12 hours after enrollment

Exclusion Criteria

  • Seizure prior to enrollment
  • Pregnancy
  • non-English speaking
  • Known intolerance of Virtual Reality
  • Patient unable to consent for themselves

Outcomes

Primary Outcomes

Change in Pain Score

Time Frame: Pre- and Post-Intervention (approximately 30 minutes)

Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain)

Secondary Outcomes

  • Opioid Administration(4 hours post-intervention vs. 4 hours pre-intervention)

Study Sites (2)

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