VR Mindfulness Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Virtual Reality Mindfulness Study

Conditions
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Anxiety, Depression, Stress, Pain, Acute, Pain, Chronic

Intervention / Treatment
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* Behavioral: Virtual Reality Based Mindfulness meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br> | Behavioral: Virtual Reality Based Mindfulness meditation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of VR Mindfulness Meditation Session | Proportion of subjects able to complete VR meditation sessions | 2 hours | 
| State Anxiety | Change in STAI-6 scores pre- and post-use of VR meditation application | 2 hours | 
| Pain severity | Change in VAS-100 scores pre- and post-use of VR meditation application | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use and acceptability | Modified User Satisfaction Evaluation Questionnaire scores after each session | 2 hours | 
| Depression | Change in BDI-SF scores pre and post-use of VR meditation | 2 hours | 
| Stress | Change in SSSQ scores pre- and post-use of VR meditation | 2 hours | 
| Long term change in Stress, Anxiety, and Depression | Change in DASS-21 scores monthly for 3 months | 3 months | 
| Long term change in Pain severity | Change in PROMIS Pain Intensity- Short Form 3a scores over 3 months | 3 months | 
| Hospital Length of Stay | Compare subject length of stay in hospital to average length of stay for admission diagnosis | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Anxiety, Depression, Pain, Mood, Mindfulness, Meditation