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Completed

NCT Number: NCT04356963

Adjunct VR 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.

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Key information

Conditions

Traumatic Brain Injury Acute Pain Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Headache Disorders Headache Disorders, Secondary Headaches Posttraumatic Nervous System Diseases Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Post-Traumatic Headache Signs and Symptoms Trauma Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

R Adams Cowley Shock Trauma Center, Baltimore, Maryland, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Pain Score

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

    Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain)

Secondary outcomes

  1. Opioid Administration

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

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

Other outcomes

  1. Change in Nausea

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

    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)

  2. Change in Anxiety

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

    Pre- vs. Post-Intervention Anxiety Ratings from Short-Form State Anxiety Inventory. Scores Range from 6 (Not at all anxious) - 24 (Very much amxious)

  3. Change Heart Rate Variability

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

    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

  4. Change in Pupillometry

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

    Pre- vs. Post-Intervention Pupillary Maximum Constriction Velocity. Reduced pupillary maximum constriction velocity is representative of decreased parasympathetic nervous system activity.

  5. Subjective Measures of VR Experience

    Time frame: Pre- and Post-study (approximately 2-3 days)

    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).

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Adjunct Virtual Reality Pain Management in Acute Brain Injury

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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