NCT04984655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

June 14, 2021

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in patient-reported stress levels on a survey

    immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience

Secondary Outcomes (6)

  • change in systolic blood pressure

    immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience

  • change in diastolic blood pressure

    immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience

  • change in heart rate

    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

    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

    immediately before 30-minute virtual reality experience and immediately after 30-minute virtual reality experience

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

All participants will go through the same intervention described above

30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Research Center, 10833 Le Conte suite BE144 - CHS building

Los Angeles, California, 90095, United States

Location

Study Officials

  • Tamara Horwich, MD, MS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pilot Study (uncontrolled)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Sciences Clinical Professor

Study Record Dates

First Submitted

June 14, 2021

First Posted

July 30, 2021

Study Start

December 13, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations