Adjunct VR Pain Management in Acute Brain Injury
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Headaches Posttraumatic
- Pain Acute
- Trauma
- Traumatic Brain Injury
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Within-Subjects DesignMasking: Single (Care Provider)Masking Description: Interventions will take place in patient rooms with curtain pulled and sign to mask active intervention vs. control intervention from care providers.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Each participant will undergo one VR session and two control sessions. The VR session will take place in a VR environment developed in our own Shock Trauma Blended Reality Center and last 20-30 minutes. The environment is based upon literature reviews on chromotherapy. The control sessions will incl...
Each participant will undergo one VR session and two control sessions. The VR session will take place in a VR environment developed in our own Shock Trauma Blended Reality Center and last 20-30 minutes. The environment is based upon literature reviews on chromotherapy. The control sessions will include a 2D-tablet based session that mimics the VR content and a content-less placement of the VR headset. The order of these sessions will be randomized across patients. 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, galvanic skin response, and pupillometry metrics. At the conclusion of all sessions, participants will complete another questionnaire to document their subjective experience of using VR.
Tracking Information
- NCT #
- NCT04356963
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nicholas A Morris, M.D. University of Maryland, College Park
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