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

12. juni 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
    • Barcelona
      • Barcelona, Barcelona, Spania
        • Hospital Clinic de Barcelona
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Annen: Treatment as Usual (TAU)
Standard pharmacological and psychotherapeutic interventions provided by the acute psychiatry ward.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Perceived Stress Scale-10 (PSS-10) score
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
World Health Organization-Five Well-Being Index (WHO-5) score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital Clinic of Barcelona

Etterforskere

  • Hovedetterforsker: Pablo Barrio Gimenez, Hospital Clinic of Barcelona

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. juni 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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