The Green Room: Virtual Nature for Mental Well-being in the Acute Psychiatry Ward (GREEN ROOM)
The Green Room: A Mixed-Methods Randomized Controlled Trial Evaluating Virtual Reality-Based Nature Exposure in an Acute Psychiatry Ward
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona
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Barcelona, Barcelona, España
- Hospital Clinic De Barcelona
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Contacto:
- Pablo Barrio
- Número de teléfono: 4210 +34932275400
- Correo electrónico: pbarrio@clinic.cat
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: VR + Treatment as Usual
Participants receive voluntary VR nature sessions (10-15 minutes, every other day) using Meta Quest 3, in addition to standar psychiatric care.
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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.
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Comparador activo: Treatment as Usual (TAU)
Participantrs receive standard pharmacological and psychotherapeutic care provided by the acute psychiatry ward, without VR sessions.
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Standard pharmacological and psychotherapeutic interventions provided by the acute psychiatry ward.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Perceived Stress Scale-10 (PSS-10) score
Periodo de tiempo: From admission (baseline) to discharge (average 2-3 weeks)
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Change in PSS-10 total score from baseline assessment (T0, al clinical stabilization) to discharge assessment (T2).
The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report questionnaire measuring the degree to which situations in one's life are appraised as stressful.
Scores range from 0 to 40, with higher scores indicating greater perceived stress.
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From admission (baseline) to discharge (average 2-3 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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World Health Organization-Five Well-Being Index (WHO-5) score
Periodo de tiempo: Through study completion, an average of 2 weeks
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The WHO-5 is a 5-item self-report measure of psychological well-being.
Raw scores range from 0 to 25, with higher scores indicating better well-being.
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Through study completion, an average of 2 weeks
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Views On Inpatient Care (VOICE) score
Periodo de tiempo: Through study completion, an average of 2 weeks
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The VOICE is a patient-reported outcome measure assessing satisfaction with inpatient psychiatric care.
Scores range from 0 to 42, with higher scores indicating greater satisfaction.
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Through study completion, an average of 2 weeks
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Client's Assessment of Treatment (CAT) score
Periodo de tiempo: Through study completion, an average of 2 weeks
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The CAT is an 8-item self-report measure of satisfaction with inpatient psychiatric treatment.
Scores range from 8 to 40, with higher scores indicating greater satisfaction.
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Through study completion, an average of 2 weeks
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Length of hospital stay
Periodo de tiempo: From admission to discharge, an average of 2 weeks
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Total number of days from admission to discharge, extracted from medical records.
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From admission to discharge, an average of 2 weeks
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Rate of discharge against medical advice (DAMA)
Periodo de tiempo: Throughout hospitalization, an average 2 weeks.
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Proportion of participants who self-discharge against medical advice during the study period.
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Throughout hospitalization, an average 2 weeks.
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State-Trait Anxiety Inventory - State subscale (STAI-S) score
Periodo de tiempo: Day 1
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The STAI-S is a 20-item self-report measure of state anxiety.
Scores range from 20 to 80, with higher scores indicating greater anxiety.
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Day 1
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Positive and Negative Affect Schedule (PANAS) score
Periodo de tiempo: Day 1
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The PANAS consists of two 10-item subscales measuring positive and negative affect.
Each subscale ranges from 10 to 50.
For the positive affect subscale, higher scores indicate more positive affect (better outcome); for the negative affect subscale, higher scores indicate more negative affect (worse outcome).
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Day 1
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System Usability Scale (SUS) score
Periodo de tiempo: Day 1
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The SUS is a 10-item questionnaire assessing perceived usability of a system.
Scores range from 0 to 100, with higher scores indicating better usability.
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Day 1
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Simulator Sickness Questionnaire (SSQ) total severity score
Periodo de tiempo: Day 1
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The SSQ is a 16-item checklist assessing symptoms of nausea, oculomotor disturbance, and disorientation associated with virtual reality use.
The total severity score ranges from 0 to 235.93, with higher scores indicating greater simulator sickness symptoms (worse outcome).
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Day 1
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Percentage of offered VR sessions accepted
Periodo de tiempo: Throughout hospitalization (intervention group only) an average 2 weeks.
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Percentage of offered VR sessions accepted by each participant in the intervention group, ranging from 0% to 100%, as a measure of intervention adherence and feasibility.
Higher percentages indicate better adherence.
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Throughout hospitalization (intervention group only) an average 2 weeks.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pablo Barrio Gimenez, Hospital Clinic of Barcelona
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HCB/2025/0704 (Identificador de registro: CEIm- Hospital Clinic de Barcelona)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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