Adjunct VR Pain Management in Acute Brain Injury

Adjunct Virtual Reality Pain Management in Acute Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Traumatic Brain Injury; Pain, Acute; Headaches Posttraumatic
• Intervention / Treatment: Behavioral: Virtual Reality Session (VR Blu); Behavioral: Tablet-based Session (Tablet Blu); Behavioral: Use of Virtual Reality Head Mounted Display without Content (VR Blank)

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)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21201
      • R Adams Cowley Shock Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All patients; 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); 20-30 minute session of virtual reality immersive content.; Behavioral: Tablet-based Session (Tablet Blu); 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 (VR Blank); 20-30 minutes session using head mounted display to reduce light and sound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Administration	Change in amount of opioids received in the 4 hours post-intervention vs. the 4 hours pre-intervention in morphine equivalents	4 hours post-intervention vs. 4 hours pre-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Nausea	Pre- vs. Post-Intervention Ratings on Numeric Rating Scale for Nausea. Numeric Rating Scale for Nausea ranges from 0 (no nausea) - 10 (worst nausea possible)	Pre- and Post-Intervention (approximately 30 minutes)
Change in Anxiety	Pre- vs. Post-Intervention Anxiety Ratings from Short-Form State Anxiety Inventory. Scores Range from 6 (Not at all anxious) - 24 (Very much amxious)	Pre- and Post-Intervention (approximately 30 minutes)
Change Heart Rate Variability	Pre- vs. Post-Intervention Heart Rate Variability as measured by normal-to-normal (NN) means. Decreasing NN means are associated with the activity of sympathetic system, while increasing NN means means are associated with the activity of parasympathetic nervous system	Mean NN from last 15 minutes of each intervention compared to mean NN from 15 minutes immediately prior to intervention
Change in Pupillometry	Pre- vs. Post-Intervention Pupillary Maximum Constriction Velocity. Reduced pupillary maximum constriction velocity is representative of decreased parasympathetic nervous system activity.	Pre- and Post-Intervention (approximately 30 minutes)
Subjective Measures of VR Experience	A Likert-Scale questionnaire was used to assess participant's subjective ratings of how effective the interventional sessions were. The scale ranged from 0 (not at all) to 5 (very much).	Pre- and Post-study (approximately 2-3 days)

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Center for Advancing Translational Sciences (NCATS); University of Maryland Baltimore, Institute for Clinical & Translational Research
• Investigators: Principal Investigator: Nicholas A Morris, M.D., University of Maryland School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2020
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Headache Disorders; Headache Disorders, Secondary; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Headache; Acute Pain; Post-Traumatic Headache
• Other Study ID Numbers: HP - 00090603; 1UL1TR003098 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No