Clinical trial NCT04356963: Adjunct VR Pain Management in Acute Brain Injury
Official title: Adjunct Virtual Reality Pain Management in Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Headaches Posttraumatic
Trauma
Pain, Acute
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Change in Pain Score
timeFrame: Pre- and Post-Intervention (approximately 30 minutes)
Secondary outcomes:
measure: Opioid Administration
timeFrame: 4 hours post-intervention vs. 4 hours pre-intervention
Other outcomes:
measure: Change in Nausea
timeFrame: Pre- and Post-Intervention (approximately 30 minutes)
measure: Change in Anxiety
timeFrame: Pre- and Post-Intervention (approximately 30 minutes)
measure: Change Heart Rate Variability
timeFrame: Mean NN from last 15 minutes of each intervention compared to mean NN from 15 minutes immediately prior to intervention
measure: Change in Pupillometry
timeFrame: Pre- and Post-Intervention (approximately 30 minutes)
measure: Subjective Measures of VR Experience
timeFrame: Pre- and Post-study (approximately 2-3 days)
Locations:
city: Baltimore
country: United States
facility: R Adams Cowley Shock Trauma Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Nicholas A Morris, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felix RB, Rao A, Khalid M, Wang Y, Colloca L, Murthi SB, Morris NA. Adjunctive virtual reality pain relief following traumatic injury: protocol for a randomised within-subjects clinical trial. BMJ Open. 2021 Nov 30;11(11):e056030. doi: 10.1136/bmjopen-2021-056030.