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Набор скоро начнётся NCT06704282

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

Без фазы С лечением Stress Anxiety Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: VR Mindfulness Meditation Program.
Кому может быть актуально
Состояния в реестре: Stress, Anxiety, Depression. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое VR Mindfulness Meditation Program
    A 15-minute guided mindfulness meditation session conducted in a virtual reality environment to enhance stress reduction and mindfulness.

Первичные конечные точки

  • Reduction in Perceived Stress Levels [Срок оценки: Immediately post-intervention (Day 1, 15 minutes after the session ends).]
  • Changes in Emotional State [Срок оценки: Immediately post-intervention (Day 1, 15 minutes after the session ends).]
  • Participant Satisfaction with Intervention [Срок оценки: Immediately post-intervention (Day 1).]
  • Physiological Stress Response [Срок оценки: Baseline (before intervention) and immediately post-intervention (Day 1).]
  • Changes in Emotional State Using STAI [Срок оценки: Baseline (prior to intervention) and immediately post-intervention (Day 1, 15 minutes after the session ends).]

Критерии участия

Критерии включения

  • Adults aged 18 years and older.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Penn State Univercity — Erie

Публикации

  • 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

Идентификаторы

NCT: NCT06704282 · STUDY00025978

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗