VR Mindfulness Study
Primary Purpose
Anxiety, Depression, Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Based Mindfulness meditation
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Virtual Reality, Anxiety, Depression, Pain, Mood, Mindfulness, Meditation
Eligibility Criteria
Inclusion Criteria:
- Adults at least 18 years old
- Able to read and understand English (Guided meditation software has not yet been translated to languages other than English)
Exclusion Criteria:
- Age <18 years old
- Unable to speak, read or understand English language
- Blindness or severe hearing impairment
- Any disability or neurological deficit that would impair subject from using the virtual reality console
- Significant movement disorder
- Vertigo and/or motion sickness
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Arm
Arm Description
Outcomes
Primary Outcome Measures
Completion of VR Mindfulness Meditation Session
Proportion of subjects able to complete VR meditation sessions
State Anxiety
Change in STAI-6 scores pre- and post-use of VR meditation application
Pain severity
Change in VAS-100 scores pre- and post-use of VR meditation application
Secondary Outcome Measures
Ease of use and acceptability
Modified User Satisfaction Evaluation Questionnaire scores after each session
Depression
Change in BDI-SF scores pre and post-use of VR meditation
Stress
Change in SSSQ scores pre- and post-use of VR meditation
Long term change in Stress, Anxiety, and Depression
Change in DASS-21 scores monthly for 3 months
Long term change in Pain severity
Change in PROMIS Pain Intensity- Short Form 3a scores over 3 months
Hospital Length of Stay
Compare subject length of stay in hospital to average length of stay for admission diagnosis
Full Information
NCT ID
NCT05592782
First Posted
October 14, 2022
Last Updated
October 19, 2022
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT05592782
Brief Title
VR Mindfulness Study
Official Title
Virtual Reality Mindfulness Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an exploratory study investigating the use of virtual reality-based guided mindfulness meditation in improving pain, stress, and mood within various clinical populations. The feasibility of utilizing VR applications within the populations of patients with various specific disease types and clinical settings is a burgeoning area of research. The goal is to establish an association between the use of VR-based mindfulness meditation, and pain, stress, and mood scores.
Detailed Description
This is a two-center, multi-site exploratory study conducted within the University of California, Los Angeles Health and Greater Los Angeles VA systems. A total of 60 subjects will be recruited. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Subjects will undergo assessments of stress, depression, anxiety, and pain at baseline, pre- and post-VR guided mediation, and monthly for three months. Each subject can undergo VR-guided meditation session no more than one time per day. In subjects who are hospitalized, an attempt will be made to have the subjects undergo the VR meditation and complete the pre- and post- meditation assessments daily until hospital discharge.
Duration of the study is expected to be 1 year. Each session is expected to last approximately 15 minutes.
Subjects will be given instructions on proper use of the VR devices and how to start the guided meditation software. Once familiar with the device, participants will undergo a guided VR meditation using a commercial VR application. The meditation will last approximately 15 minutes. Prior to starting and on upon completion of each VR meditation session, participants' state pain, anxiety, depression, and stress will be assessed. For each participant enrolled, baseline and monthly assessments using the DASS-21 and PPI-SFI3a will be performed for three consecutive months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Stress, Pain, Acute, Pain, Chronic
Keywords
Virtual Reality, Anxiety, Depression, Pain, Mood, Mindfulness, Meditation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Based Mindfulness meditation
Intervention Description
Participants will undergo a guided VR meditation using a commercial VR application. The meditation will last approximately 15 minutes. Prior to starting and on upon completion of each VR meditation session, participants' state pain, anxiety, depression, and stress will be assessed. For each participant enrolled, baseline and monthly assessments using the DASS-21 and PPI-SFI3a will be performed for three consecutive months.
Primary Outcome Measure Information:
Title
Completion of VR Mindfulness Meditation Session
Description
Proportion of subjects able to complete VR meditation sessions
Time Frame
2 hours
Title
State Anxiety
Description
Change in STAI-6 scores pre- and post-use of VR meditation application
Time Frame
2 hours
Title
Pain severity
Description
Change in VAS-100 scores pre- and post-use of VR meditation application
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Ease of use and acceptability
Description
Modified User Satisfaction Evaluation Questionnaire scores after each session
Time Frame
2 hours
Title
Depression
Description
Change in BDI-SF scores pre and post-use of VR meditation
Time Frame
2 hours
Title
Stress
Description
Change in SSSQ scores pre- and post-use of VR meditation
Time Frame
2 hours
Title
Long term change in Stress, Anxiety, and Depression
Description
Change in DASS-21 scores monthly for 3 months
Time Frame
3 months
Title
Long term change in Pain severity
Description
Change in PROMIS Pain Intensity- Short Form 3a scores over 3 months
Time Frame
3 months
Title
Hospital Length of Stay
Description
Compare subject length of stay in hospital to average length of stay for admission diagnosis
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults at least 18 years old
Able to read and understand English (Guided meditation software has not yet been translated to languages other than English)
Exclusion Criteria:
Age <18 years old
Unable to speak, read or understand English language
Blindness or severe hearing impairment
Any disability or neurological deficit that would impair subject from using the virtual reality console
Significant movement disorder
Vertigo and/or motion sickness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Herman Davidovics, MD
Phone
323-649-5155
Email
hdavidovics@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Naiem, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
VR Mindfulness Study
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