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

12 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
    • Barcelona
      • Barcelona, Barcelona, Spanien
        • Hospital Clinic de Barcelona
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Aktiv komparator: Treatment as Usual (TAU)
Participantrs receive standard pharmacological and psychotherapeutic care provided by the acute psychiatry ward, without VR sessions.
Övrig: Treatment as Usual (TAU)
Standard pharmacological and psychotherapeutic interventions provided by the acute psychiatry ward.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Perceived Stress Scale-10 (PSS-10) score
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
World Health Organization-Five Well-Being Index (WHO-5) score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Clinic of Barcelona

Utredare

  • Huvudutredare: Pablo Barrio Gimenez, Hospital Clinic of Barcelona

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 juni 2026

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2025

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HCB/2025/0704 (Registeridentifierare: CEIm- Hospital Clinic de Barcelona)

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