Adjunct VR Pain Management in Acute Brain Injury

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Within-Subjects Design
Primary Purpose
Treatment
Masking
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Virtual Reality Sessions
All participants will participate in virtual reality sessions.
  • Behavioral: Virtual Reality Session
    20-30 minute session of virtual reality immersive content.
Active Comparator
Comparator Sessions
All participants will participate in tablet-based sessions to content-less sessions wearing the virtual reality headset
  • Behavioral: Tablet-based Session
    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
    20-30 minutes session using head mounted display to reduce light and sound.

Recruiting Locations

R Adams Cowley Shock Trauma Center
Baltimore, Maryland 21201
Contact:
Sarah Murthi, M.D.
SMurthi@som.umaryland.edu

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Nicholas A Morris, MD
410-328-9423
nicholas.morris@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Nicholas A Morris, MD
410-328-4515
Nicholas.Morris@som.umaryland.edu

Detailed 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 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.