Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04356963
Other study ID # HP - 00090603
Secondary ID 1UL1TR003098
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Terminated NCT03698747 - Myelin Imaging in Concussed High School Football Players
Recruiting NCT05130658 - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training N/A
Recruiting NCT04560946 - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI N/A
Completed NCT05160194 - Gaining Real-Life Skills Over the Web N/A
Recruiting NCT02059941 - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04465019 - Exoskeleton Rehabilitation on TBI
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Suspended NCT04244058 - Changes in Glutamatergic Neurotransmission of Severe TBI Patients Early Phase 1
Completed NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Recruiting NCT04274777 - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn NCT04199130 - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI N/A
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1
Withdrawn NCT04257435 - The Utility of Positive Psychology in Military TBI Rehabilitation N/A