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Набор скоро начнётся NCT07108556

Brief Mindfulness Workshop With or Without Virtual Reality: A Pilot Study

Без фазы С лечением Mental Wellbeing

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: Mindfulness VR-Typical, Mindfulness Typical-VR.
Кому может быть актуально
Состояния в реестре: Mental Wellbeing. 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
Гонконг
Следующий шаг
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Официальное название

Brief Mindfulness Workshop With or Without Virtual Reality: A Randomized Crossover Design

Обзор

The current study uses a randomized cross-over design, in which participants are exposed to brief mindfulness-based experiential sessions with and without incorporating virtual reality (i.e., the experimental and control conditions, respectively). Order of exposure to these two conditions are counter-balanced and participants are randomized into the two arms of exposure in a different order. Furthermore, this study includes the use of both subjective self-report and objective physiological measures of mental wellbeing. It is hypothesized that VR-incorporated mindfulness-based experiential session brings a greater improvement in state mindfulness, state affect, and stress response. Results shed light on the added value of incorporating VR into brief MBIs, particularly in reference to the typical practice of promoting mindfulness in the local community.

Вмешательства

  • Поведенческое Mindfulness VR-Typical
    Participants first experience mindfulness exercise with virtual reality incorporated, then another mindfulness exercise with only audio-guidance as typically delivered without the technology
  • Поведенческое Mindfulness Typical-VR
    Participants first experience mindfulness exercise with only audio-guidance, then another mindfulness exercise with virtual reality incorporated

Первичные конечные точки

  • Change in positive affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness. [Срок оценки: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).]
  • Change in negative affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness. [Срок оценки: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).]
  • Change in state mindfulness as measured by the State Mindfulness Scale (SMS) after a brief practice of mindfulness. [Срок оценки: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).]
  • Change in heart rate variability as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness. [Срок оценки: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).]
  • Change in skin conductance level as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness. [Срок оценки: At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).]
Вторичные конечные точки (1)
  • Satisfaction with the intervention as measured by a single Likert item with open text entry designed specifically for this study [Срок оценки: At the end of the full program (i.e., one-time assessment; at minute 20).]

Критерии участия

Критерии включения

  • aged 18 years or older
  • reads Chinese
  • understands Cantonese

Критерии исключения

  • history of sever motion sickness or known intolerance to VR environments
  • impairments that may interfere with the use of VR equipment
  • concurrent or past structured mindfulness training

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • New Life Psychiatric Rehabilitation Association — Kowloon

Идентификаторы

NCT: NCT07108556 · EA250376

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗