- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04984655
Virtual Reality Experience for Stress Reduction in Cardiology Patients
Pilot Study: Virtual Reality Experience for Stress Reduction in Cardiology Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Clinical and Translational Research Center, 10833 Le Conte suite BE144 - CHS building
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older
- Current patient in University of California, Los Angeles (UCLA) Cardiology clinics and/or cardiac rehab
- English speaking
- Able to give informed consent
Exclusion Criteria:
- history of seizure
- facial injury preventing safe placement of headset, significant visual or hearing impairment (as defined as not able to see/hear clearly even with corrective lenses/aids).
- Individuals with dangerous, unstable arrhythmias (VTACH/VFIB) and/or myocardial infarction (MI) in past 4 week, or individuals in acute decompensated heart failure
- respiratory issues, postural instability, and motion sickness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset
|
All participants will go through the same intervention described above
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in patient-reported stress levels on a survey
Time Frame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in systolic blood pressure
Time Frame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
change in diastolic blood pressure
Time Frame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
change in heart rate
Time Frame: immediately before 30-minute virtual reality experience, during the 30-minute virtual reality experience, immediately after 30-minute virtual reality experience
|
immediately before 30-minute virtual reality experience, during the 30-minute virtual reality experience, immediately after 30-minute virtual reality experience
|
change in heart rate variability
Time Frame: immediately before 30-minute virtual reality experience, during the 30-minute virtual reality experience, immediately after 30-minute virtual reality experience
|
immediately before 30-minute virtual reality experience, during the 30-minute virtual reality experience, immediately after 30-minute virtual reality experience
|
change in respiration rate
Time Frame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
|
change in galvanic skin response
Time Frame: immediately before 30-minute virtual reality experience, during the 30-immediately after 30-minute virtual reality experience
|
immediately before 30-minute virtual reality experience, during the 30-immediately after 30-minute virtual reality experience
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tamara Horwich, MD, MS, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21-000705
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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