StressNCT04984655
Virtual Reality Experience for Stress Reduction in Cardiology Patients
A study testing 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset in people with Stress and Blood Pressure, run by University of California, Los Angeles at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Blood Pressure, Virtual Reality
- What is being tested?
- 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Center, 10833 Le Conte suite BE144 - CHS building
Los Angeles, California, 90095
About this study
Official title: Pilot Study: Virtual Reality Experience for Stress Reduction in Cardiology Patients
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.
Read the 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.
- Conditions
- Stress, Blood Pressure, Virtual Reality, Prevention
- Being tested
- 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headsetDevice
All participants will go through the same intervention described above
| Study group | Role | What they receive |
|---|---|---|
| 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset | Other | Not described Receives: Device: 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in patient-reported stress levels on a survey
Measured: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
Secondary outcomes (6)
change in systolic blood pressure
Measured: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
change in diastolic blood pressure
Measured: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
change in heart rate
Measured: 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
Measured: 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
Measured: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
change in galvanic skin response
Measured: immediately before 30-minute virtual reality experience, during the 30-immediately after 30-minute virtual reality experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start13 Dec 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study (uncontrolled)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Horwich, University of California, Los Angeles
- Investigators
- Tamara Horwich, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984655
- Sponsor's protocol ID
- 21-000705
- Status last verified
- Jan 2023
- First submitted
- 14 Jun 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Virtual Reality Experience for Stress Reduction in Cardiology Patients
- ClinicalTrials.gov ID
- NCT04984655
- Acronym / sponsor ID
- 21-000705
- Conditions
- Stress, Blood Pressure, Virtual Reality, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot Study (uncontrolled)
| Arm | Type | Receives |
|---|---|---|
| 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset | Other | Device: 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headsetAll participants will go through the same intervention described above | Device | 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset |
Primary outcome
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
6 secondary outcomes
change in systolic blood pressure
Time frame: 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
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
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
change in respiration rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Horwich, MD, MS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset in people with Stress and Blood Pressure, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.