The Green Room: Virtual Nature for Mental Well-being in the Acute Psychiatry Ward
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 Nature Exposure, Treatment as Usual (TAU).
- Кому может быть актуально
- Состояния в реестре: Mental Disorders, Psychiatric Hospitalization, Stress (Psychology). 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
- Испания
- 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
The Green Room: A Mixed-Methods Randomized Controlled Trial Evaluating Virtual Reality-Based Nature Exposure in an Acute Psychiatry Ward
Обзор
This study evaluates the feasibility, acceptability and clinical impact of a virtual reality (VR)- based nature intervention in an acute psychiatric inpatient unit. Participants are randomly assigned to recieve VR nature sessions (using Nature Treks VR on Meta Quest 3) in addition to standard care, or standard care alone. The primary outcome is change in percieved stress (PSS-19) from admission to discharge. The study uses a mixed-methods design combining randomized controlled trial with a qualitative phase.
Подробное описание
THE GREEN ROOM is a sequential, explanatory mixed-methods study comprising two phases. Phase 1 is a qualitative study (n=40; patients and healthcare professionals) using the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework to identify barriers and facilitators to VR implementation in an acute psychiatric ward, and to co-create the final VR intervention content with patients and staff. Phase 2 is the randomised controlled trial described in this record.
Phase 2 participants are randomised 1:1 to receive VR-based nature exposure sessions (Nature Treks VR, Meta Quest 3) in addition to treatment as usual, or treatment as usual alone. Randomisation is stratified by legal admission status (voluntary vs. involuntary) using two separate pre-generated sequential allocation lists (n=60 per stratum). Allocation concealment is maintained through sequential, pre-fixed assignment managed by the research assistant; the Principal Investigator remains blinded to individual allocations during data collection, and the statistical analyst remains blinded until the analysis plan is finalised and locked.
Intervention-group participants are offered VR sessions of 10\\u201315 minutes approximately every other day throughout hospitalisation, on a strictly voluntary basis. Participants may freely choose and switch between all nature environments available within the Nature Treks VR application. During the first VR session, a consecutive sub-sample of intervention participants (estimated n\\u224850) additionally undergo physiological monitoring (heart rate and heart rate variability) using a consumer-grade wearable device (Fitbit).
The primary analysis will use a mixed-design ANOVA (or ANCOVA with baseline score as covariate) to evaluate change in PSS-10 from admission to discharge, following an intention-to-treat approach. Missing data will be handled under a Missing-At-Random assumption within the mixed-effects model framework, with complete-case analysis as a sensitivity check. Two exploratory subgroup analyses are pre-specified: by legal admission status and by primary diagnostic category.
Вмешательства
- Поведенческое Virtual Reality Nature Exposure
Voluntary immersive nature sessions using Nature Treks VR softwere on Meta Quest 3 head-mounted displays. Sessions last 10-15 minutes and are offered every other day throughout hospitalization. Participants freely choose among all available nature environments within the application. - Другое Treatment as Usual (TAU)
Standard pharmacological and psychotherapeutic interventions provided by the acute psychiatry ward.
Первичные конечные точки
- Change in Perceived Stress Scale-10 (PSS-10) score [Срок оценки: From admission (baseline) to discharge (average 2-3 weeks)]
Вторичные конечные точки (10)
- World Health Organization-Five Well-Being Index (WHO-5) score [Срок оценки: Through study completion, an average of 2 weeks]
- Views On Inpatient Care (VOICE) score [Срок оценки: Through study completion, an average of 2 weeks]
- Client's Assessment of Treatment (CAT) score [Срок оценки: Through study completion, an average of 2 weeks]
- Length of hospital stay [Срок оценки: From admission to discharge, an average of 2 weeks]
- Rate of discharge against medical advice (DAMA) [Срок оценки: Throughout hospitalization, an average 2 weeks.]
- State-Trait Anxiety Inventory - State subscale (STAI-S) score [Срок оценки: Day 1]
- Positive and Negative Affect Schedule (PANAS) score [Срок оценки: Day 1]
- System Usability Scale (SUS) score [Срок оценки: Day 1]
- Simulator Sickness Questionnaire (SSQ) total severity score [Срок оценки: Day 1]
- Percentage of offered VR sessions accepted [Срок оценки: Throughout hospitalization (intervention group only) an average 2 weeks.]
Критерии участия
Критерии включения
Adults aged 18 to 65 years. Admitted to the Acute Psychiatry Ward (regardless of voluntary or involuntary legal status).
Sufficient cognitive and clinical stability to provide informed consent and engage with the VR equipment, as determined by the clinical team.
Ability to communicate effectively in Spanish.
Критерии исключения
History of photosensitive epilepsy or severe seizure disorders. Presence of active facial injuries, infections, or skin conditions that prevent the hygienic use of the VR headset.
Pre-existing severe vertigo, balance disorders, or high susceptibility to motion sickness.
Acute clinical state involving high risk of agitation or behavioral dysregulation that could compromise participant or equipment safety.
Severe visual or hearing impairments that cannot be corrected and would hinder the VR experience.
Patients who have previously participated in the study during a prior admission are not eligible for re-enrolment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Испания · 1 центр
- Hospital Clinic de Barcelona — Barcelona
Идентификаторы
NCT: NCT07655063 · HCB/2025/0704 · HCB/2025/0704