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

N/ANot Yet RecruitingNCT07655063

Hospital Clinic of Barcelona120 enrolled

Overview

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.

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.

Study Type

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: From admission (baseline) to discharge (average 2-3 weeks)

Secondary Outcomes

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

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.

Time frame: Through study completion, an average of 2 weeks

Views On Inpatient Care (VOICE) score

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.

Time frame: Through study completion, an average of 2 weeks

Client's Assessment of Treatment (CAT) score

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.

Time frame: Through study completion, an average of 2 weeks

Length of hospital stay

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

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

Rate of discharge against medical advice (DAMA)

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

Time frame: Throughout hospitalization, an average 2 weeks.

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

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.

Time frame: Day 1

Positive and Negative Affect Schedule (PANAS) score

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).

Time frame: Day 1

System Usability Scale (SUS) score

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.

Time frame: Day 1

Simulator Sickness Questionnaire (SSQ) total severity score

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).

Time frame: Day 1

Percentage of offered VR sessions accepted

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.

Time frame: Throughout hospitalization (intervention group only) an average 2 weeks.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes