Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04984655 |
| Other study ID # |
21-000705 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2021 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the research is to evaluate the feasibility and scalability of delivering a
30-minute novel virtual reality (VR) experience through the Oculus Quest 2 Virtual Reality
headset with the aim of measuring changes in: 1) patient-reported stress levels on a survey,
2) blood pressure, 3)heart rate, 4) respiration rate 5) heart rate variability 6) and
galvanic skin response in cardiology clinic and cardiac rehabilitation patients.
Description:
After consenting to participate, participants will be asked to complete a pre-experience
questionnaire. The investigators will ask participants questions to evaluate their general
and current state of stress as well as gather some baseline health information. Although the
questionnaires ask questions about anxiety, they are being conducted for research purposes,
so if participants are feeling anxious they should discuss this with their primary care
provider or other doctor. The investigators think it should take about 5 minutes to complete
the pre-experience questionnaire. If participants feel uncomfortable or embarrassed answering
any question, they may skip it. The questionnaire will not contain any information that could
be used to identify participants. If participants do not feel comfortable answering surveys
then this would result in withdrawal from the study. Participants would be politely notified
of your withdrawal and not complete the study.
Participants will then place the VR headset over their head along with over the ear
headphones. The research member will ensure safety and comfort then instruct participant how
to begin the experience through the headset. The experience includes relaxing images, shapes,
and colors that change and evolve slowly. These visuals are also paired with music, which can
be adjusted at the start of the experience with the assistance of the researcher (participant
will not have to control sound or light). Participants will not have a choice as to the
content viewed during this experience. If at any time during the experience participant would
like to stop, you may feel free to signal to the researcher, ask to stop, or just remove the
headset and headphones.
After completion of the experience, participants will be asked to complete a post-experience
survey. Investigators think this should take about 5 minutes to complete. Investigators will
again ask about stress levels. Investigators will also gather feedback from participant about
thoughts and attitudes towards the VR experience for stress reduction and potential
usefulness in cardiac rehabilitation.
Physiological measures will be collected and monitored as follows: The heart rate and heart
rate variability will be monitored via the PolarH10 heart rate monitor and chest strap and
transmitted to the safely encrypted computer/tablet. There will be no info transmitted with
the data aside from the time/date of the collecting. This will be a continuous recording from
5 minutes after you sit down to complete the survey until 5 minutes after the experience. The
blood pressure cuff will be used 3 times: 5 minutes after you sit down but prior to the
experience, at 15 minutes during the experience, and at the end of the experience.
Respiratory rate will be observed by the researcher while you enter the survey data, and
every 10 minutes during the experience, then as you complete the post-survey for a total of 5
measurements. The galvanic skin response (sweat gland activity) sensor will be placed at the
same time as the heart rate monitor and will provide continuous monitoring for 5 minutes
prior to the start of the experience and 5 minutes post-experience.
