Trial Outcomes & Findings for A Study to Assess Virtual Reality by Healthcare Providers: A Pilot Study (NCT NCT04622527)
NCT ID: NCT04622527
Last Updated: 2024-01-02
Results Overview
STAI Y1 anxiety measurement of the change from post-test score to pre-test score. The STAI Y1 has 20 questions on a scale from 1 to 4. The minimum score is 20 and the maximum is 80. The lower the score the better the outcome. Our outcome looks at the difference between the post-test from the pre-test, so the minimum change score is -60 and the maximum change score is 60. A higher change in score would mean that a subject experienced a worse outcome after the paradigm, while a lower change in score shows a better outcome after the paradigm than before.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
2 weeks
Results posted on
2024-01-02
Participant Flow
The study included a total of 4 treatment interventions to which every participant was exposed. Subjects were randomized to one of the 24 unique treatment sequences.
Participant milestones
| Measure |
A = First Viewing of Virtual Reality Paradigm A
Paradigm A with virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with viewing paradigm A with Virtual Reality headgear.
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
B = First Viewing of Virtual Reality Paradigm B
Paradigm B with virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order viewing paradigm B with Virtual Reality headgear.
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
C = First Viewing of Non-Virtual Reality Paradigm A
Paradigm A without virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with viewing paradigm A with Computer screen.
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
D = First Viewing of Non-Virtual Reality Paradigm B
Paradigm B without virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigm in a random order beginning with viewing paradigm B with Computer screen.
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Virtual Reality by Healthcare Providers: A Pilot Study
Baseline characteristics by cohort
| Measure |
A = First Viewing of Virtual Reality Paradigm A
n=6 Participants
Begin with Paradigm A virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with Paradigm A with virtual reality headgear
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
B = First Viewing of Virtual Reality Paradigm B
n=6 Participants
Begin with Paradigm B virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with Paradigm B with virtual reality headgear
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
C = First Viewing of Non-Virtual Reality Paradigm A
n=6 Participants
Begin with Paradigm A without virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigms in a random order beginning with Paradigm A through computer screen
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
D = First Viewing of Non-Virtual Reality Paradigm B
n=6 Participants
Begin with Paradigm B without virtual reality headgear
Random assigned paradigm viewing order: Participants experience all 4 paradigm in a random order beginning with Paradigm B through computer screen
The 4 paradigms are:
A = Virtual Reality Paradigm A, B = Virtual Reality Paradigm B, C = Non-Virtual Reality Paradigm A, D = Non-Virtual Reality Paradigm B
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
46.3 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: All 24 subjects experienced each of the 4 virtual reality paradigms. Before and after each paradigm, a STAI Y1 survey was given. The outcomes below shows the change between post and pre for all subjects, no matter what order they viewed the paradigm.
STAI Y1 anxiety measurement of the change from post-test score to pre-test score. The STAI Y1 has 20 questions on a scale from 1 to 4. The minimum score is 20 and the maximum is 80. The lower the score the better the outcome. Our outcome looks at the difference between the post-test from the pre-test, so the minimum change score is -60 and the maximum change score is 60. A higher change in score would mean that a subject experienced a worse outcome after the paradigm, while a lower change in score shows a better outcome after the paradigm than before.
Outcome measures
| Measure |
A = Virtual Reality Paradigm A
n=24 Participants
Paradigm A with virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
B = Virtual Reality Paradigm B
n=24 Participants
Paradigm B with virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
C = Non-Virtual Reality Paradigm A
n=24 Participants
Paradigm A without virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
D = Non-Virtual Reality Paradigm B
n=24 Participants
Paradigm B without virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
|---|---|---|---|---|
|
State-Trait Anxiety Inventory (STAI Y1)
|
-6.4 units on a scale
Standard Deviation 5.98
|
-5.8 units on a scale
Standard Deviation 9.29
|
-4.1 units on a scale
Standard Deviation 6.22
|
-5.0 units on a scale
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: 2 weeksAcceptability of Virtual Reality measured by a question from the satisfaction survey done at the end of the study. The question asked was "Was it worthwhile for you to participate in this research study?".
Outcome measures
| Measure |
A = Virtual Reality Paradigm A
n=6 Participants
Paradigm A with virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
B = Virtual Reality Paradigm B
n=6 Participants
Paradigm B with virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
C = Non-Virtual Reality Paradigm A
n=6 Participants
Paradigm A without virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
D = Non-Virtual Reality Paradigm B
n=6 Participants
Paradigm B without virtual reality headgear
Random assigned paradigm viewing order: Participants experience the paradigm in a random order
|
|---|---|---|---|---|
|
Was the Study Worthwhile
No
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Was the Study Worthwhile
Yes
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
|
Was the Study Worthwhile
Unsure
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
A = Virtual Reality Paradigm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B = Virtual Reality Paradigm B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C = Non-Virtual Reality Paradigm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D = Non-Virtual Reality Paradigm B
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place