Assessing the Impact of VR-Based Observational Mindfulness Meditation on Stress Reduction in Adults

NCT06704282 | Not Yet Recruiting

• 1 other identifier: STUDY00025978
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress; Anxiety; Depression

Keywords

Mindfulness; Virtual Reality; Meditation; Observe Activity

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline (prior to intervention) and immediately post-intervention (Day 1, 15 minutes after the session ends).

Study Arms (1)

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.

Behavioral: VR Mindfulness Meditation Program

Interventions

VR Mindfulness Meditation Program BEHAVIORAL

A 15-minute guided mindfulness meditation session conducted in a virtual reality environment to enhance stress reduction and mindfulness.

Mindfulness Meditation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older.

You may not qualify if:

• Those with visual or hearing impairments that prevent interaction with VR content.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State Univercity

Erie, Pennsylvania, 16563, United States

Location

Related Publications (1)

• 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.

  PMID: 41130677 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Scholar

Model Details: Participants will be randomly assigned to either the experimental group, receiving mindfulness-based VR observational meditation, or the control group, undergoing standard relaxation techniques.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: November 25, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 23, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

US (1)