Adjunct VR Pain Management in Acute Brain Injury

NCT04356963 | Completed Results

• 2 other identifiers: HP - 000906031UL1TR003098
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Pre- and Post-Intervention (approximately 30 minutes)

Secondary Outcomes (1)

• Opioid Administration

  4 hours post-intervention vs. 4 hours pre-intervention

Other Outcomes (5)

• Change in Nausea

  Pre- and Post-Intervention (approximately 30 minutes)

• Change in Anxiety

  Pre- and Post-Intervention (approximately 30 minutes)

• Change Heart Rate Variability

  Mean NN from last 15 minutes of each intervention compared to mean NN from 15 minutes immediately prior to intervention

Study Arms (1)

All patients

EXPERIMENTAL

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.

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

Interventions

Virtual Reality Session (VR Blu) BEHAVIORAL

20-30 minute session of virtual reality immersive content.

All patients

Tablet-based Session (Tablet Blu) BEHAVIORAL

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

All patients

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.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Seizure prior to enrollment
• Pregnancy
• non-English speaking
• Known intolerance of Virtual Reality
• Patient unable to consent for themselves

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• Morris NA, Wang Y, Felix RB, Rao A, Arnold S, Khalid M, Armahizer MJ, Murthi SB, Colloca L. Adjunctive virtual reality pain relief after traumatic injury: a proof-of-concept within-person randomized trial. Pain. 2023 Sep 1;164(9):2122-2129. doi: 10.1097/j.pain.0000000000002914. Epub 2023 Apr 19.

  PMID: 37079851 DERIVED

• 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.

  PMID: 34848527 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Traumatic Headache; Wounds and Injuries; Acute Pain

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Headache Disorders, Secondary; Headache Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Very few patients with TBI met inclusion criteria. The intervals between conditions were quite short to improve feasibility of study completion based on brief anticipated length of stay. This limited our ability to evaluate effects on opioid use and duration of VR intervention effect. The sample size limited our ability to account for multiple comparisons.

Results Point of Contact

• Title: Dr. Nicholas Morris
• Organization: University of Maryland School of Medicine

nicholas.morris@som.umaryland.edu

410-328-4515

Study Officials

• Nicholas A Morris, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Interventions will take place in patient rooms with curtain pulled and sign to mask active intervention vs. control intervention from care providers.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: September 5, 2020
• Primary Completion: January 7, 2022
• Study Completion: April 30, 2022
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)