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NCT Number: NCT06704282

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

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.

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Key information

Conditions

Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years and older.

Exclusion criteria

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

Treatment and study plan

VR Mindfulness Meditation Program

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Effects of VR-Based Mindfulness Observational Meditation for Stress Reduction in Adults : Randomized Controlled Trial

Acronym: VR-MOM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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