Adjunct VR Pain Management in Acute Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Adjunct Virtual Reality Pain Management in Acute Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356963
• Other study ID #: HP - 00090603
• Secondary ID: 1UL1TR003098
• Status: Completed
• Phase: N/A
• Start date: September 5, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Brain Injuries
• Brain Injuries, Traumatic
• Headache
• Headaches Posttraumatic
• Pain, Acute
• Post-Traumatic Headache
• Trauma
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Virtual Reality Session (VR Blu)
20-30 minute session of virtual reality immersive content.
• Tablet-based Session (Tablet Blu)
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)
20-30 minutes session using head mounted display to reduce light and sound.

Locations

Country	Name	City	State
United States	R Adams Cowley Shock Trauma Center	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Center for Advancing Translational Sciences (NCATS), University of Maryland Baltimore, Institute for Clinical & Translational Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Other	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)
Other	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)
Primary	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	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