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NCT Number: NCT07655063

The Green Room: Virtual Nature for Mental Well-being in the 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Nature Exposure

Behavioral

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.

Treatment as usual (TAU)

Other

Standard pharmacological and psychotherapeutic interventions provided by the acute psychiatry ward.

Primary outcomes

  1. Change in Perceived Stress Scale-10 (PSS-10) score

    Time frame: 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.

Secondary outcomes

  1. World Health Organization-Five Well-Being Index (WHO-5) score

    Time frame: 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.

  2. Views On Inpatient Care (VOICE) score

    Time frame: 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.

  3. Client's Assessment of Treatment (CAT) score

    Time frame: 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.

  4. Length of hospital stay

    Time frame: From admission to discharge, an average of 2 weeks

    Total number of days from admission to discharge, extracted from medical records.

  5. Rate of discharge against medical advice (DAMA)

    Time frame: Throughout hospitalization, an average 2 weeks.

    Proportion of participants who self-discharge against medical advice during the study period.

  6. State-Trait Anxiety Inventory - State subscale (STAI-S) score

    Time frame: 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.

  7. Positive and Negative Affect Schedule (PANAS) score

    Time frame: 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).

  8. System Usability Scale (SUS) score

    Time frame: 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.

  9. Simulator Sickness Questionnaire (SSQ) total severity score

    Time frame: 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).

  10. Percentage of offered VR sessions accepted

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: GREEN ROOM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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