Adjunct VR Pain Management in Acute Brain Injury

Study Overview
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Brief Summary
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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
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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)

Official Title
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Adjunct Virtual Reality Pain Management in Acute Brain Injury

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

Intervention / Treatment
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* Behavioral: Virtual Reality Session (VR Blu)
* Behavioral: Tablet-based Session (Tablet Blu)
* Behavioral: Use of Virtual Reality Head Mounted Display without Content (VR Blank)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Within-Subjects Design. All participants (single group, 1 arm) intended to complete all three sessions (interventions) in randomized order. At least 4 hours were required to pass between each session to allow for washout.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>All patients were intended to engage in three different 20-30 min sessions run by research coordinators and spaced a minimum of 4 hours apart to allow for washout of effects, including 1) a commercially available, immersive VR environment, theBlu (WEVR, Inc, Venice, California, USA) delivered via Oculus Rift (Oculus VR, Irvine, California, USA) headset (VR Blu), 2) a non-immersive two-dimensional mimic delivered via a tablet computer (Tablet Blu), and 3) a VR control session delivered via a content-less Oculus Rift headset (VR Blank). The three sessions were run by research coordinators and spaced a minimum of 4 hours apart. The intervention order was counterbalanced using a randomized sequence generator. | Behavioral: Virtual Reality Session (VR Blu)<br>* 20-30 minute session of virtual reality immersive content.<br>Behavioral: Tablet-based Session (Tablet Blu)<br>* 20-30 minute session of tablet-based content that mimics the content from virtual reality sessions.<br>Behavioral: Use of Virtual Reality Head Mounted Display without Content (VR Blank)<br>* 20-30 minutes session using head mounted display to reduce light and sound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score | Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain) | Pre- and Post-Intervention (approximately 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Administration | Change in amount of opioids received in the 4 hours post-intervention vs. the 4 hours pre-intervention in morphine equivalents | 4 hours post-intervention vs. 4 hours pre-intervention |