StressVR-MOMNCT06704282
Assessing the Impact of VR-Based Observational Mindfulness Meditation on Stress Reduction in Adults
A study testing VR Mindfulness Meditation Program in people with Stress and Anxiety, run by Penn State University at 1 site in United States.
Trial summary
This study investigates the impact of a mindfulness-based intervention using virtual reality (VR) and artificial intelligence (AI) coaching on stress reduction. Participants will engage in VR-based observation mindfulness activities guided by an AI coach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- VR Mindfulness Meditation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 23 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged 18 years and older.
Who cannot join
- Those with visual or hearing impairments that prevent interaction with VR content.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn State Univercity
Erie, Pennsylvania, 16563
Jiheun Hong, Master, 630-877-7467, jbh6626@psu.edu
About this study
Official title: Effects of VR-Based Mindfulness Observational Meditation for Stress Reduction in Adults : Randomized Controlled Trial
This study investigates the impact of a mindfulness-based intervention using virtual reality (VR) and artificial intelligence (AI) coaching on stress reduction. Participants will engage in VR-based observation mindfulness activities guided by an AI coach. The study aims to evaluate the effectiveness of this intervention compared to a standard relaxation process by measuring self-reported stress levels, physiological biomarkers (e.g., heart rate), and participant satisfaction. The research could inform the development of future digital mental health interventions.
Read the detailed description
This study employs a randomized controlled design to assess the effectiveness of a VR-based mindfulness intervention for stress reduction. Participants are randomly assigned to either the experimental group, which undergoes VR-based observation mindfulness activities guided by an AI coach, or the control group, which experiences standard relaxation exercises. Pre-intervention data, including self-reported stress levels (measured via PSS-10, DASS-21, and STAI) and baseline heart rate, are collected. Following the intervention, participants complete post-intervention measurements to evaluate changes in stress levels, physiological responses, and satisfaction with the VR program.
The experimental group participates in mindfulness activities designed to enhance attention to detail and present-moment awareness through object observation within the VR environment. The AI coach facilitates the session by prompting reflective and observational questions, fostering deeper engagement. The control group undergoes relaxation exercises with no active mindfulness engagement. All procedures are conducted in a controlled laboratory setting, ensuring consistency and minimizing external variables.
The study collects objective (heart rate and heart rate variability) and subjective (self-reported stress and satisfaction) data to evaluate the intervention's efficacy. The findings aim to provide insights into the feasibility and benefits of integrating VR and AI technologies in stress reduction interventions. The results will also contribute to the development of more engaging and accessible digital mindfulness practices for diverse populations.
- Conditions
- Stress, Anxiety, Depression
- Being tested
- VR Mindfulness Meditation Program
- Keywords
- Mindfulness, Virtual Reality, Meditation, Observe Activity
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Mindfulness Meditation ProgramBehavioural
A 15-minute guided mindfulness meditation session conducted in a virtual reality environment to enhance stress reduction and mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Group | Experimental | Participants in this arm will undergo a 15-minute VR-based mindfulness observational meditation session guided by a virtual coach. The intervention focuses on promoting mindfulness and reducing stress through structured guidance in a controlled virtual environment. Receives: Behavioral: VR Mindfulness Meditation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Perceived Stress Levels
Changes in perceived stress levels measured using the Perceived Stress Scale (PSS-10) to assess the effectiveness of the VR-based mindfulness observational meditation intervention.
Measured: Immediately post-intervention (Day 1, 15 minutes after the session ends).
Changes in Emotional State
Emotional state assessed using the Depression Anxiety Stress Scales (DASS-21) and the State-Trait Anxiety Inventory (STAI). These indicators will be evaluated pre- and post-intervention to measure reductions in anxiety and overall emotional improvement.
Measured: Immediately post-intervention (Day 1, 15 minutes after the session ends).
Participant Satisfaction with Intervention
Participant satisfaction assessed via a structured satisfaction survey post-intervention, including feedback on usability, perceived effectiveness, and comfort with the VR program.
Measured: Immediately post-intervention (Day 1).
Physiological Stress Response
Heart rate measured pre- and post-intervention using a heart rate monitor to assess changes in physiological stress levels as a biomarker.
Measured: Baseline (before intervention) and immediately post-intervention (Day 1).
Changes in Emotional State Using STAI
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), which measures both state and trait anxiety components. The STAI-S (State Anxiety) evaluates participants' current feelings, while the STAI-T (Trait Anxiety) measures participants' general tendencies toward anxiety. Measurements will be taken pre- and post-intervention to evaluate reductions in anxiety.
Measured: Baseline (prior to intervention) and immediately post-intervention (Day 1, 15 minutes after the session ends).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start25 Nov 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion23 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the experimental group, receiving mindfulness-based VR observational meditation, or the control group, undergoing standard relaxation techniques.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiHeun Hong, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704282
- Sponsor's protocol ID
- STUDY00025978
- Acronym
- VR-MOM
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will be made available upon request. All shared data will be fully anonymized to protect participant confidentiality and privacy. Researchers can request access by contacting the primary investigator at the provided email address. Access will be granted for non-commercial research purposes only, subject to review and approval by the study team.
Publications
Hong J, Shelton CR, Oh H. Randomised controlled trial of VR-based observation meditation with AI coaching ('Otti') for stress reduction in university students in the United States: study protocol. BMJ Open. 2025 Oct 23;15(10):e097236. doi: 10.1136/bmjopen-2024-097236.
PubMed 41130677
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of VR-Based Mindfulness Observational Meditation for Stress Reduction in Adults : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06704282
- Acronym / sponsor ID
- VR-MOM / STUDY00025978
- Conditions
- Stress, Anxiety, Depression
- Keywords
- Mindfulness, Virtual Reality, Meditation, Observe Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 23 Feb 2025 (estimated)
- First posted
- 26 Nov 2024 (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 study investigates the impact of a mindfulness-based intervention using virtual reality (VR) and artificial intelligence (AI) coaching on stress reduction. Participants will engage in VR-based observation mindfulness activities guided by an AI coach. The study aims to evaluate the effectiveness of this intervention compared to a standard relaxation process by measuring self-reported stress levels, physiological biomarkers (e.g., heart rate), and participant satisfaction. The research could inform the development of future digital mental health interventions.
Detailed description
This study employs a randomized controlled design to assess the effectiveness of a VR-based mindfulness intervention for stress reduction. Participants are randomly assigned to either the experimental group, which undergoes VR-based observation mindfulness activities guided by an AI coach, or the control group, which experiences standard relaxation exercises. Pre-intervention data, including self-reported stress levels (measured via PSS-10, DASS-21, and STAI) and baseline heart rate, are collected. Following the intervention, participants complete post-intervention measurements to evaluate changes in stress levels, physiological responses, and satisfaction with the VR program.
The experimental group participates in mindfulness activities designed to enhance attention to detail and present-moment awareness through object observation within the VR environment. The AI coach facilitates the session by prompting reflective and observational questions, fostering deeper engagement. The control group undergoes relaxation exercises with no active mindfulness engagement. All procedures are conducted in a controlled laboratory setting, ensuring consistency and minimizing external variables.
The study collects objective (heart rate and heart rate variability) and subjective (self-reported stress and satisfaction) data to evaluate the intervention's efficacy. The findings aim to provide insights into the feasibility and benefits of integrating VR and AI technologies in stress reduction interventions. The results will also contribute to the development of more engaging and accessible digital mindfulness practices for diverse populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be randomly assigned to either the experimental group, receiving mindfulness-based VR observational meditation, or the control group, undergoing standard relaxation techniques.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Group | Experimental | Behavioral: VR Mindfulness Meditation ProgramParticipants in this arm will undergo a 15-minute VR-based mindfulness observational meditation session guided by a virtual coach. The intervention focuses on promoting mindfulness and reducing stress through structured guidance in a controlled virtual environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years and older.
Key exclusion criteria (1 listed)
- Those with visual or hearing impairments that prevent interaction with VR content.
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 |
|---|---|---|
| VR Mindfulness Meditation ProgramA 15-minute guided mindfulness meditation session conducted in a virtual reality environment to enhance stress reduction and mindfulness. | Behavioural | Mindfulness Meditation Group |
Primary outcome
Reduction in Perceived Stress Levels
Time frame: Immediately post-intervention (Day 1, 15 minutes after the session ends).
Changes in perceived stress levels measured using the Perceived Stress Scale (PSS-10) to assess the effectiveness of the VR-based mindfulness observational meditation intervention.
Changes in Emotional State
Time frame: Immediately post-intervention (Day 1, 15 minutes after the session ends).
Emotional state assessed using the Depression Anxiety Stress Scales (DASS-21) and the State-Trait Anxiety Inventory (STAI). These indicators will be evaluated pre- and post-intervention to measure reductions in anxiety and overall emotional improvement.
Participant Satisfaction with Intervention
Time frame: Immediately post-intervention (Day 1).
Participant satisfaction assessed via a structured satisfaction survey post-intervention, including feedback on usability, perceived effectiveness, and comfort with the VR program.
Physiological Stress Response
Time frame: Baseline (before intervention) and immediately post-intervention (Day 1).
Heart rate measured pre- and post-intervention using a heart rate monitor to assess changes in physiological stress levels as a biomarker.
Changes in Emotional State Using STAI
Time frame: Baseline (prior to intervention) and immediately post-intervention (Day 1, 15 minutes after the session ends).
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), which measures both state and trait anxiety components. The STAI-S (State Anxiety) evaluates participants' current feelings, while the STAI-T (Trait Anxiety) measures participants' general tendencies toward anxiety. Measurements will be taken pre- and post-intervention to evaluate reductions in anxiety.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 41130677Hong J, Shelton CR, Oh H. Randomised controlled trial of VR-based observation meditation with AI coaching ('Otti') for stress reduction in university students in the United States: study protocol. BMJ Open. 2025 Oct 23;15(10):e097236. doi: 10.1136/bmjopen-2024-097236.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be made available upon request. All shared data will be fully anonymized to protect participant confidentiality and privacy. Researchers can request access by contacting the primary investigator at the provided email address. Access will be granted for non-commercial research purposes only, subject to review and approval by the study team.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Mindfulness Meditation Program in people with Stress and Anxiety, run by Penn State University at 1 site in United States.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Perceived Stress Levels (time frame: Immediately post-intervention (Day 1, 15 minutes after the session ends).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704282, which also lists 1 linked publication.
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 26 Nov 2024.