N/A N=60 Treatment

Adjunct VR Pain Management in Acute Brain Injury

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

Bottom Line

View on ClinicalTrials.gov: NCT04356963 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Change in Pain Score — -0.92; -0.16; -1.24 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Virtual Reality Session (VR Blu) (Behavioral); Tablet-based Session (Tablet Blu) (Behavioral); Use of Virtual Reality Head Mounted Display without Content (VR Blank) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Score	-0.92; -0.16; -1.24	—
SECONDARY Opioid Administration	-0.159; -0.89; -0.059	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04356963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.