Adjunct VR Pain Management in Acute Brain Injury

University of Maryland, Baltimore60 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury Headaches Posttraumatic Trauma Pain, Acute

Interventions

Virtual Reality Session (VR Blu)BEHAVIORAL

20-30 minute session of virtual reality immersive content.

Tablet-based Session (Tablet Blu)BEHAVIORAL

20-30 minute session of tablet-based content that mimics the content from virtual reality sessions.

Use of Virtual Reality Head Mounted Display without Content (VR Blank)BEHAVIORAL

20-30 minutes session using head mounted display to reduce light and sound.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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)

Time frame: Pre- and Post-Intervention (approximately 30 minutes)

Secondary Outcomes

Opioid Administration

Change in amount of opioids received in the 4 hours post-intervention vs. the 4 hours pre-intervention in morphine equivalents

Time frame: 4 hours post-intervention vs. 4 hours pre-intervention

Data from ClinicalTrials.gov

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