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Virtual Reality Experience for Stress Reduction in Cardiology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04984655
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Tamara Horwich, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Stress Blood Pressure Virtual Reality Prevention Device: 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset Not Applicable

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 yparticipants. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot Study (uncontrolled)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study: Virtual Reality Experience for Stress Reduction in Cardiology Patients
Actual Study Start Date : December 13, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset Device: 30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset
All participants will go through the same intervention described above




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. change in systolic blood pressure [ Time Frame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience ]
  2. change in diastolic blood pressure [ Time Frame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience ]
  3. 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 ]
  4. 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 ]
  5. change in respiration rate [ Time Frame: immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience ]
  6. change in galvanic skin response [ Time Frame: immediately before 30-minute virtual reality experience, during the 30-immediately after 30-minute virtual reality experience ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Current patient in 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 MI in past 4 week, or individuals in acute decompensated heart failure
  • respiratory issues, postural instability, and motion sickness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984655


Contacts
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Contact: Katherine Makaroff, BA 781-277-1897 kmakaroff@mednet.ucla.edu
Contact: Tamara Horwich, MD, MS 310-825-9011 thorwich@mednet.ucla.edu

Locations
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United States, California
Clinical and Translational Research Center, 10833 Le Conte suite BE144 - CHS building Recruiting
Los Angeles, California, United States, 90095
Contact: Katherine Makaroff    781-277-1897    kmakaroff@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Tamara Horwich, MD, MS University of California, Los Angeles
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Responsible Party: Tamara Horwich, Health Sciences Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04984655    
Other Study ID Numbers: 21-000705
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No