Clinical trial NCT04984655: Virtual Reality Experience for Stress Reduction in Cardiology Patients
Official title: Pilot Study: Virtual Reality Experience for Stress Reduction in Cardiology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Blood Pressure
Virtual Reality
Prevention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot Study (uncontrolled)
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in patient-reported stress levels on a survey
timeFrame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
Secondary outcomes:
measure: change in systolic blood pressure
timeFrame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
measure: change in diastolic blood pressure
timeFrame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
measure: change in heart rate
timeFrame: immediately before 30-minute virtual reality experience, during the 30-minute virtual reality experience, immediately after 30-minute virtual reality experience
measure: change in heart rate variability
timeFrame: immediately before 30-minute virtual reality experience, during the 30-minute virtual reality experience, immediately after 30-minute virtual reality experience
measure: change in respiration rate
timeFrame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience
measure: change in galvanic skin response
timeFrame: immediately before 30-minute virtual reality experience, during the 30-immediately after 30-minute virtual reality experience
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical and Translational Research Center, 10833 Le Conte suite BE144 - CHS building
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Tamara Horwich, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: