Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1UL1TR003098 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Session (VR Blu) | Behavioral | 20-30 minute session of virtual reality immersive content. |
|
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas A Morris, M.D. | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States | ||
| University of Maryland Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37079851 | Derived | 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. | |
| 34848527 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All 60 patients were intended to participate in all 3 conditions in randomized order. 60 of 60 patients had session order randomized.
2083 patients were screened for eligibility between October 2020 and January 2022 in a dedicated trauma hospital. 1885 patients were excluded. 138 patients declined to participate in the study. 60 patients were enrolled in the study. All patients were intended to participate in all conditions (in randomized order) including: VR Blu, Tablet Blu, VR Blank.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patients engaged in three different 20 min sessions run by research coordinators and spaced a minimum of 4 hours apart, 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. All participants were expected to complete all three sessions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Session |
|
| |||||||||||||||||||||||||||
| Second Session |
| ||||||||||||||||||||||||||||
| Third Session |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients engaged in three different 20 min sessions run by research coordinators and spaced a minimum of 4 hours apart, including 1) a commercially available, immersive VR environment, theBlu (WEVR, Inc, Venice, California, USA) delivered via Oculus Rift (Oculus VR, Irvine, California, USA) headset, 2) a non-immersive two-dimensional mimic delivered via a tablet computer, and 3) a VR control session delivered via a content-less Oculus Rift headset. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Error | score on a scale | Pre- and Post-Intervention (approximately 30 minutes) |
|
Duration of Study Involvement (typically < 48 hours)
Potential side-effects of VR were measured before and after each session, including neck pain, nausea, dizziness, and light sensitivity according to a NRS ranging from 0 (no symptom) to 10 (worst possible symptom). Before and immediately after each session, we also collected vital sign measurements (blood pressure and heart rate).
All participants were intended to participate in all three interventions therefore they are reported as a single arm/group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All Participants were intended to participate in all three interventions. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicholas Morris | University of Maryland School of Medicine | 410-328-4515 | nicholas.morris@som.umaryland.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2021 | Apr 1, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2021 | May 21, 2021 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D051298 | Post-Traumatic Headache |
| D014947 | Wounds and Injuries |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Interventions will take place in patient rooms with curtain pulled and sign to mask active intervention vs. control intervention from care providers.
Not provided
| 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. |
|
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) |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Completed VR Blank |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Completed VR Blank |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Acute Injury Scale > 0 | Number | participants |
|
| Type of Traumatic Brain Injury | Number | participants |
|
| Past Medical History | Number | participants |
|
| Health Insurance | Count of Participants | Participants |
|
|
|
| Secondary | Opioid Administration | Change in amount of opioids received in the 4 hours post-intervention vs. the 4 hours pre-intervention in morphine equivalents | Posted | Mean | Standard Error | morphine milligram equivalents | 4 hours post-intervention vs. 4 hours pre-intervention |
|
|
|
| Other Pre-specified | 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) | Posted | Mean | Standard Error | score on a scale | Pre- and Post-Intervention (approximately 30 minutes) |
|
|
|
| Other Pre-specified | 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) | Posted | Mean | Standard Error | score on a scale | Pre- and Post-Intervention (approximately 30 minutes) |
|
|
|
| Other Pre-specified | 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 | Posted | Mean | Standard Error | ms | Mean NN from last 15 minutes of each intervention compared to mean NN from 15 minutes immediately prior to intervention |
|
|
|
| Other Pre-specified | Change in Pupillometry | Pre- vs. Post-Intervention Pupillary Maximum Constriction Velocity. Reduced pupillary maximum constriction velocity is representative of decreased parasympathetic nervous system activity. | Posted | Mean | Standard Error | mm/s | Pre- and Post-Intervention (approximately 30 minutes) |
|
|
|
| Other Pre-specified | 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). | Posted | Mean | Standard Error | score on a scale | Pre- and Post-study (approximately 2-3 days) |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Measurements |
|---|
|
|
|
|
|
|