Trial Outcomes & Findings for Adjunct VR Pain Management in Acute Brain Injury (NCT NCT04356963)
NCT ID: NCT04356963
Last Updated: 2023-04-24
Results Overview
Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Pre- and Post-Intervention (approximately 30 minutes)
Results posted on
2023-04-24
Participant Flow
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.
All 60 patients were intended to participate in all 3 conditions in randomized order. 60 of 60 patients had session order randomized.
Participant milestones
| Measure |
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.
|
|---|---|
|
First Session
STARTED
|
60
|
|
First Session
Completed VR Blu
|
21
|
|
First Session
Completed Tablet Blu
|
19
|
|
First Session
Completed VR Blank
|
19
|
|
First Session
COMPLETED
|
59
|
|
First Session
NOT COMPLETED
|
1
|
|
Second Session
STARTED
|
59
|
|
Second Session
Completed VR Blu
|
17
|
|
Second Session
Completed Tablet Blu
|
23
|
|
Second Session
Completed VR Blank
|
15
|
|
Second Session
COMPLETED
|
55
|
|
Second Session
NOT COMPLETED
|
4
|
|
Third Session
STARTED
|
55
|
|
Third Session
Completed VR Blu
|
14
|
|
Third Session
Completed Tablet Blu
|
12
|
|
Third Session
Completed VR Blank
|
22
|
|
Third Session
COMPLETED
|
48
|
|
Third Session
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
First Session
Withdrawal by Subject
|
1
|
|
Second Session
Withdrawal by Subject
|
3
|
|
Second Session
Lost to Follow-up
|
1
|
|
Third Session
Lost to Follow-up
|
6
|
|
Third Session
Withdrawal by Subject
|
1
|
Baseline Characteristics
Adjunct VR Pain Management in Acute Brain Injury
Baseline characteristics by cohort
| Measure |
All Patients
n=60 Participants
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.
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Acute Injury Scale > 0
Head
|
29 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Head with Traumatic Brain Injury
|
20 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Face
|
20 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Neck
|
8 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Thoracic
|
26 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Abdominal
|
29 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Spine
|
15 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Upper Extremity
|
28 participants
n=5 Participants
|
|
Acute Injury Scale > 0
Lower Extremity
|
35 participants
n=5 Participants
|
|
Type of Traumatic Brain Injury
Intracerebral Hemorrhage
|
13 participants
n=5 Participants
|
|
Type of Traumatic Brain Injury
Subdural hematoma
|
10 participants
n=5 Participants
|
|
Type of Traumatic Brain Injury
Subarachnoid hemorrhage
|
8 participants
n=5 Participants
|
|
Type of Traumatic Brain Injury
Epidural hematoma
|
1 participants
n=5 Participants
|
|
Past Medical History
Depression
|
18 participants
n=5 Participants
|
|
Past Medical History
Anxiety
|
16 participants
n=5 Participants
|
|
Past Medical History
Chronic Pain
|
13 participants
n=5 Participants
|
|
Past Medical History
Alcohol Abuse
|
13 participants
n=5 Participants
|
|
Past Medical History
Positive Toxicology Screen
|
32 participants
n=5 Participants
|
|
Health Insurance
Private
|
39 Participants
n=5 Participants
|
|
Health Insurance
Medicare
|
16 Participants
n=5 Participants
|
|
Health Insurance
Medicaid
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
All Patients
n=59 Participants
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.
Virtual Reality Session: 20-30 minute session of virtual reality immersive content.
Tablet-based Session: 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: 20-30 minutes session using head mounted display to reduce light and sound.
|
|---|---|
|
Change in Pain Score
VR Blu Intervention Pain Reduction
|
-0.92 score on a scale
Standard Error 0.33
|
|
Change in Pain Score
Tablet Blu Intervention Pain Reduction
|
-0.16 score on a scale
Standard Error 0.29
|
|
Change in Pain Score
VR Blank Intervention Pain Reduction
|
-1.24 score on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: 4 hours post-intervention vs. 4 hours pre-interventionChange in amount of opioids received in the 4 hours post-intervention vs. the 4 hours pre-intervention in morphine equivalents
Outcome measures
| Measure |
All Patients
n=59 Participants
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.
Virtual Reality Session: 20-30 minute session of virtual reality immersive content.
Tablet-based Session: 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: 20-30 minutes session using head mounted display to reduce light and sound.
|
|---|---|
|
Opioid Administration
Change in opioid dose received after Tablet Blu
|
-0.89 morphine milligram equivalents
Standard Error 1.175
|
|
Opioid Administration
Change in opioid dose received after VR Blank
|
-0.059 morphine milligram equivalents
Standard Error 1.341
|
|
Opioid Administration
Changes in opioid dose received after VR Blu condition
|
-0.159 morphine milligram equivalents
Standard Error 1.392
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
All Patients
n=59 Participants
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.
Virtual Reality Session: 20-30 minute session of virtual reality immersive content.
Tablet-based Session: 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: 20-30 minutes session using head mounted display to reduce light and sound.
|
|---|---|
|
Change in Nausea
Change in nausea after VR Blu
|
-0.116 score on a scale
Standard Error 0.304
|
|
Change in Nausea
Change in nausea after Tablet Blu
|
-0.395 score on a scale
Standard Error 0.248
|
|
Change in Nausea
Change in nausea after VR Blank
|
-0.093 score on a scale
Standard Error 0.057
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
All Patients
n=59 Participants
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.
Virtual Reality Session: 20-30 minute session of virtual reality immersive content.
Tablet-based Session: 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: 20-30 minutes session using head mounted display to reduce light and sound.
|
|---|---|
|
Change in Anxiety
changes in STAI score after VR Blue
|
-.061 score on a scale
Standard Error 0.311
|
|
Change in Anxiety
Changes in STAI score after Tablet Blue
|
-0.401 score on a scale
Standard Error 0.32
|
|
Change in Anxiety
Changes in STAI score after VR Blank
|
-0.675 score on a scale
Standard Error 0.501
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Mean NN from last 15 minutes of each intervention compared to mean NN from 15 minutes immediately prior to interventionPre- 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
Outcome measures
| Measure |
All Patients
n=25 Participants
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.
Virtual Reality Session: 20-30 minute session of virtual reality immersive content.
Tablet-based Session: 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: 20-30 minutes session using head mounted display to reduce light and sound.
|
|---|---|
|
Change Heart Rate Variability
VR Blu induced change in mean NN (NN from last 15 min of session minus NN 15 min pre-session)
|
874.64 ms
Standard Error 15.36
|
|
Change Heart Rate Variability
Tablet Blu induced change in mean NN (NN from last 15 min of session minus NN 15 min pre-session)
|
834.78 ms
Standard Error 1.93
|
|
Change Heart Rate Variability
VR Blank induced change in mean NN (NN from last 15 min of session minus NN 15 min pre-session)
|
867.64 ms
Standard Error 10.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
All Patients
n=42 Participants
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.
Virtual Reality Session: 20-30 minute session of virtual reality immersive content.
Tablet-based Session: 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: 20-30 minutes session using head mounted display to reduce light and sound.
|
|---|---|
|
Change in Pupillometry
VR Blue change in maximum constriction velocity
|
0.187 mm/s
Standard Error 0.112
|
|
Change in Pupillometry
Tablet Blue change in maximum constriction velocity
|
-0.047 mm/s
Standard Error 0.097
|
|
Change in Pupillometry
VR Blank change in maximum constriction velocity
|
-0.299 mm/s
Standard Error 0.149
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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).
Outcome measures
| Measure |
All Patients
n=59 Participants
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.
Virtual Reality Session: 20-30 minute session of virtual reality immersive content.
Tablet-based Session: 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: 20-30 minutes session using head mounted display to reduce light and sound.
|
|---|---|
|
Subjective Measures of VR Experience
VR Blu Perceived Effectiveness on Likert Scale (0-5, not at all effective - very effective)
|
3.63 score on a scale
Standard Error 0.23
|
|
Subjective Measures of VR Experience
Tablet Blu Perceived Effectiveness on Likert Scale (0-5, not at all effective - very effective)
|
2.68 score on a scale
Standard Error 0.23
|
|
Subjective Measures of VR Experience
VR Blank Perceived Effectiveness on Likert Scale (0-5, not at all effective - very effective)
|
1.52 score on a scale
Standard Error 0.29
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nicholas Morris
University of Maryland School of Medicine
Phone: 410-328-4515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place