Adjunct VR Pain Management in Acute Brain Injury

Not Applicable

Completed

Conditions: Pain, Acute
Trauma
Traumatic Brain Injury
Headaches Posttraumatic

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

Registration Number: NCT04356963

Lead Sponsor: University of Maryland, Baltimore

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Virtual Reality Session (VR Blu)	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.
All patients	Tablet-based Session (Tablet Blu)	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.
All patients	Use of Virtual Reality Head Mounted Display without Content (VR Blank)	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Score	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 Outcome Measures

Name	Time	Method
Opioid Administration	4 hours post-intervention vs. 4 hours pre-intervention	Change in amount of opioids received in the 4 hours post-intervention vs. the 4 hours pre-intervention in morphine equivalents

Trial Locations

Locations (2): R Adams Cowley Shock Trauma Center
🇺🇸
Baltimore, Maryland, United States
University of Maryland Medical Center
🇺🇸
Baltimore, Maryland, United States