Trial Outcomes & Findings for Virtual Reality to Promote Relaxation Prior to Simulation (NCT NCT06318338)
NCT ID: NCT06318338
Last Updated: 2026-03-27
Results Overview
Feasibility based on the ability of at least 75% patient VR completion rate. Based on the expected accrual of 25 patients, futility and early termination will be triggered if six participants fail to meet the conditions described above.
COMPLETED
NA
25 participants
1 Day
2026-03-27
Participant Flow
Participant milestones
| Measure |
Virtual Reality Program
This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.
Virtual Reality Program: Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.
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|---|---|
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Overall Study
STARTED
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25
|
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality to Promote Relaxation Prior to Simulation
Baseline characteristics by cohort
| Measure |
Virtual Reality Program
n=25 Participants
This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.
Virtual Reality Program: Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=56 Participants
|
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Age, Categorical
Between 18 and 65 years
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14 Participants
n=56 Participants
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Age, Categorical
>=65 years
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11 Participants
n=56 Participants
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Age, Continuous
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65 years
n=56 Participants
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Sex: Female, Male
Female
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11 Participants
n=56 Participants
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Sex: Female, Male
Male
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14 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=56 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
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1 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=56 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=56 Participants
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Race (NIH/OMB)
White
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21 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
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Region of Enrollment
United States
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25 participants
n=56 Participants
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PRIMARY outcome
Timeframe: 1 DayFeasibility based on the ability of at least 75% patient VR completion rate. Based on the expected accrual of 25 patients, futility and early termination will be triggered if six participants fail to meet the conditions described above.
Outcome measures
| Measure |
Virtual Reality Program
n=25 Participants
This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.
Virtual Reality Program: Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.
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|---|---|
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Feasibility of a Pre-simulation VR Platform Prior to Radiation
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25 Participants
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SECONDARY outcome
Timeframe: 1 DayPrior to the intervention, patients completed the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire that includes two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D), each rated on a 0-3 scale. Raw scores range from 0-21 with higher scores indicating higher anxiety or depression, for each subscale respectively. Scores on a scale greater than eight indicate clinically significant anxiety or depression. This survey was only delivered at one time-point which was prior to use of the VR program.
Outcome measures
| Measure |
Virtual Reality Program
n=25 Participants
This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.
Virtual Reality Program: Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.
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|---|---|
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Patient Situational Anxiety Prior to and After Use of VR Program (HADS)
HADS-A
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11.1 Score on HADS Scale
Standard Deviation 2.64
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Patient Situational Anxiety Prior to and After Use of VR Program (HADS)
HADS-D
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9.0 Score on HADS Scale
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: 1 DayThe State-Trait Anxiety Inventory (STAI-6) is a validated short form of the 20-item STAI 6-item questionnaire. It contains six items ("I am tense", "I feel upset", "I am relaxed", "I feel content", "I am worried", "I feel calm.") rated on a 1-4 Likert scale to assess situational anxiety. Raw scores range from 6-24, with higher scores indicating higher situational anxiety. Total STAI-6 scores are multiplied by 20 and divided by six to give a score between 20-80, consistent with the 20-item questionnaire. Scores on a scale of 40 or higher is correlated with clinically significant anxiety. The STAI-6 was delivered at two time-points, prior to and after use of the VR program.
Outcome measures
| Measure |
Virtual Reality Program
n=25 Participants
This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.
Virtual Reality Program: Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.
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|---|---|
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Patient Situational Anxiety Prior to and After Use of VR Program (STAI-6)
Pre Intervention
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43.3 score on a scale
Standard Deviation 12.4
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Patient Situational Anxiety Prior to and After Use of VR Program (STAI-6)
Post Intervention
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29.3 score on a scale
Standard Deviation 9.6
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Adverse Events
Virtual Reality Program
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