AnxietyNCT05592782
VR Mindfulness Study
A study testing Virtual Reality Based Mindfulness meditation in people with Anxiety and Depression, run by University of California, Los Angeles.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Stress
- What is being tested?
- Virtual Reality Based Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Conditions
- Anxiety, Depression, Stress, Pain, Acute, Pain, Chronic
- Being tested
- Virtual Reality Based Mindfulness meditation
- Keywords
- Virtual Reality, Anxiety, Depression, Pain, Mood, Mindfulness, Meditation
- Medical subject headings
- Anxiety Disorders, Depression, Acute Pain, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Based Mindfulness meditationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Not described Receives: Behavioral: Virtual Reality Based Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of VR Mindfulness Meditation Session
Proportion of subjects able to complete VR meditation sessions
Measured: 2 hours
State Anxiety
Change in STAI-6 scores pre- and post-use of VR meditation application
Measured: 2 hours
Pain severity
Change in VAS-100 scores pre- and post-use of VR meditation application
Measured: 2 hours
Secondary outcomes (6)
Ease of use and acceptability
Modified User Satisfaction Evaluation Questionnaire scores after each session
Measured: 2 hours
Depression
Change in BDI-SF scores pre and post-use of VR meditation
Measured: 2 hours
Stress
Change in SSSQ scores pre- and post-use of VR meditation
Measured: 2 hours
Long term change in Stress, Anxiety, and Depression
Change in DASS-21 scores monthly for 3 months
Measured: 3 months
Long term change in Pain severity
Change in PROMIS Pain Intensity- Short Form 3a scores over 3 months
Measured: 3 months
Hospital Length of Stay
Compare subject length of stay in hospital to average length of stay for admission diagnosis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: PI left UCLA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arash Naiem, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592782
- Sponsor's protocol ID
- IRB#22-001517
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Mindfulness Study
- ClinicalTrials.gov ID
- NCT05592782
- Acronym / sponsor ID
- IRB#22-001517
- Conditions
- Anxiety, Depression, Stress, Pain, Acute, Pain, Chronic
- Keywords
- Virtual Reality, Anxiety, Depression, Pain, Mood, Mindfulness, Meditation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left UCLA
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Behavioral: Virtual Reality Based Mindfulness meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Based Mindfulness meditationParticipants 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. | Behavioural | Study Arm |
Primary outcome
Completion of VR Mindfulness Meditation Session
Time frame: 2 hours
Proportion of subjects able to complete VR meditation sessions
State Anxiety
Time frame: 2 hours
Change in STAI-6 scores pre- and post-use of VR meditation application
Pain severity
Time frame: 2 hours
Change in VAS-100 scores pre- and post-use of VR meditation application
6 secondary outcomes
Ease of use and acceptability
Time frame: 2 hours
Depression
Time frame: 2 hours
Stress
Time frame: 2 hours
Long term change in Stress, Anxiety, and Depression
Time frame: 3 months
Long term change in Pain severity
Time frame: 3 months
Hospital Length of Stay
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Naiem, MD, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Based Mindfulness meditation in people with Anxiety and Depression, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of VR Mindfulness Meditation Session (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.