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The Green Room: Virtual Nature for Mental Well-being in the Acute Psychiatry Ward (GREEN ROOM)

12 giugno 2026 aggiornato da: Hospital Clinic of Barcelona

The Green Room: A Mixed-Methods Randomized Controlled Trial Evaluating Virtual Reality-Based Nature Exposure in an Acute Psychiatry Ward

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
    • Barcelona
      • Barcelona, Barcelona, Spagna
        • Hospital Clínic de Barcelona
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: Treatment as Usual (TAU)
Participantrs receive standard pharmacological and psychotherapeutic care provided by the acute psychiatry ward, without VR sessions.
Altro: Treatment as Usual (TAU)
Standard pharmacological and psychotherapeutic interventions provided by the acute psychiatry ward.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Perceived Stress Scale-10 (PSS-10) score
Lasso di tempo: From admission (baseline) to discharge (average 2-3 weeks)
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.
From admission (baseline) to discharge (average 2-3 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
World Health Organization-Five Well-Being Index (WHO-5) score
Lasso di tempo: Through study completion, an average of 2 weeks
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.
Through study completion, an average of 2 weeks
Views On Inpatient Care (VOICE) score
Lasso di tempo: Through study completion, an average of 2 weeks
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.
Through study completion, an average of 2 weeks
Client's Assessment of Treatment (CAT) score
Lasso di tempo: Through study completion, an average of 2 weeks
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.
Through study completion, an average of 2 weeks
Length of hospital stay
Lasso di tempo: From admission to discharge, an average of 2 weeks
Total number of days from admission to discharge, extracted from medical records.
From admission to discharge, an average of 2 weeks
Rate of discharge against medical advice (DAMA)
Lasso di tempo: Throughout hospitalization, an average 2 weeks.
Proportion of participants who self-discharge against medical advice during the study period.
Throughout hospitalization, an average 2 weeks.
State-Trait Anxiety Inventory - State subscale (STAI-S) score
Lasso di tempo: Day 1
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.
Day 1
Positive and Negative Affect Schedule (PANAS) score
Lasso di tempo: Day 1
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).
Day 1
System Usability Scale (SUS) score
Lasso di tempo: Day 1
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.
Day 1
Simulator Sickness Questionnaire (SSQ) total severity score
Lasso di tempo: Day 1
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).
Day 1
Percentage of offered VR sessions accepted
Lasso di tempo: Throughout hospitalization (intervention group only) an average 2 weeks.
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.
Throughout hospitalization (intervention group only) an average 2 weeks.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital Clinic of Barcelona

Investigatori

  • Investigatore principale: Pablo Barrio Gimenez, Hospital Clinic of Barcelona

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 giugno 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 giugno 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HCB/2025/0704 (Identificatore di registro: CEIm- Hospital Clinic de Barcelona)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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