Clinical trial NCT06704282: Assessing the Impact of VR-Based Observational Mindfulness Meditation on Stress Reduction in Adults
Official title: Effects of VR-Based Mindfulness Observational Meditation for Stress Reduction in Adults : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Depression
Keywords: Mindfulness
Virtual Reality
Meditation
Observe Activity
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older.

Exclusion Criteria:

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

Primary outcomes:
measure: Reduction in Perceived Stress Levels
timeFrame: Immediately post-intervention (Day 1, 15 minutes after the session ends).
measure: Changes in Emotional State
timeFrame: Immediately post-intervention (Day 1, 15 minutes after the session ends).
measure: Participant Satisfaction with Intervention
timeFrame: Immediately post-intervention (Day 1).
measure: Physiological Stress Response
timeFrame: Baseline (before intervention) and immediately post-intervention (Day 1).
measure: Changes in Emotional State Using STAI
timeFrame: Baseline (prior to intervention) and immediately post-intervention (Day 1, 15 minutes after the session ends).
Secondary outcomes:
Other outcomes:
Locations:
city: Erie
country: United States
facility: Penn State Univercity
state: Pennsylvania
Study officials:
References: