Virtual Forest-Based Mindfulness for Perinatal Mental Health
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: Virtual Reality Forest Mindfulness Intervention, Conventional Mindfulness Intervention.
- Кому может быть актуально
- Состояния в реестре: Perinatal Anxiety, Perinatal Depression, Maternal Mental Health. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluating the Effects of an Integrated Virtual Forest Environment and Mindfulness-Based Intervention on Mental Health in Perinatal Women
Обзор
Perinatal anxiety and depression are common mental health concerns that may negatively affect maternal well-being, infant development, and family functioning. Mindfulness-based interventions have shown beneficial effects on reducing psychological distress during pregnancy; however, maintaining attention and engagement during mindfulness practice may be challenging for some pregnant women. This randomized controlled trial aims to evaluate the feasibility and effectiveness of an integrated virtual forest environment and mindfulness-based intervention for improving mental health in perinatal women. Pregnant women between 20 and 24 weeks of gestation will be randomly assigned to either an experimental group receiving virtual reality (VR)-based forest mindfulness intervention or a control group receiving conventional mindfulness intervention. Both groups will participate in a 9-week mindfulness program and receive app-based mindfulness practice. The experimental group will additionally receive immersive VR forest-based mindfulness sessions during prenatal visits. Outcomes including anxiety, depression, mindfulness awareness, physiological indicators, and intervention acceptability will be assessed during pregnancy and postpartum follow-up.
Вмешательства
- Поведенческое Virtual Reality Forest Mindfulness Intervention
Participants will receive immersive virtual reality-based forest mindfulness intervention combined with mindfulness-guided practice during pregnancy. - Поведенческое Conventional Mindfulness Intervention
Participants will receive conventional mindfulness-guided intervention during pregnancy without virtual reality exposure. The intervention includes mindfulness-guided audio focusing on breathing awareness, emotional regulation, present-moment attention, and maternal-fetal connection. Participants will additionally receive a 9-week mindfulness program and app-based mindfulness practice.
Первичные конечные точки
- Generalized Anxiety Disorder-7 (GAD-7) Score [Срок оценки: Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum]
- Edinburgh Postnatal Depression Scale (EPDS) Score [Срок оценки: Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum]
Вторичные конечные точки (6)
- Mindful Attention Awareness Scale (MAAS) Score [Срок оценки: Baseline (20-24 weeks gestation), post-intervention (32 weeks gestation to before delivery), and 1 month, 3 months, and 6 months postpartum]
- Heart Rate Variability [Срок оценки: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy]
- Systolic and Diastolic Blood Pressure [Срок оценки: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy]
- Fetal Heart Rate [Срок оценки: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy]
- Intervention Acceptability and Satisfaction [Срок оценки: Immediately after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy]
- State Mindfulness Scale (SMS) Score [Срок оценки: Immediately before and after each of the four in-person intervention sessions conducted between 24 and 32 weeks of gestation during pregnancy]
Критерии участия
Критерии включения
- Pregnant women aged 18 years or older
- Gestational age below 25 weeks at recruitment
- Able to communicate in Chinese and provide informed consent
- Willing to participate in the study and complete follow-up assessments
Критерии исключения
- Diagnosed epilepsy, photosensitive epilepsy, or other neurological disorders
- Severe anxiety, depression, or other psychiatric disorders currently receiving intensive treatment
- History of severe adverse reactions to virtual reality devices, including severe dizziness, nausea, or visual discomfort
- Inability to participate in mindfulness or VR intervention proceduresriteria:
Критерии исключения
\-
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
- Профилактика
Центры проведения
Тайвань · 1 центр
- National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital — Hsinchu
Идентификаторы
NCT: NCT07606248 · 202504140RINC