VR Mindfulness Study

Virtual Reality Mindfulness Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Stress; Anxiety; Pain, Acute; Pain, Chronic
• Intervention / Treatment: Behavioral: Virtual Reality Based Mindfulness meditation

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Arm

Behavioral: Virtual Reality Based Mindfulness meditation; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Arash Naiem, MD, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Pain; Anxiety; Mindfulness; Virtual Reality; Meditation; Mood
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Anxiety Disorders; Chronic Pain; Depression; Acute Pain
• Other Study ID Numbers: IRB#22-001517

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No