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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
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Virtual Reality, Anxiety, Depression, Pain, Mood, Mindfulness, Meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 14, 2022
    Last Updated
    October 19, 2022
    Sponsor
    University of California, Los Angeles
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    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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