Multicenter Randomized Controlled Trial Investigating the Psychological Effects of a Nature-Based VR Intervention in Multimorbid Elderly Patients - ZenctuaryVR+, Within the Framework of the HU-RIZONT International Excellence Research Collaboration Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Change in Psychological Distress (Hospital Anxiety and Depression Scale total score)
Study Overview
Brief Summary
Prolonged hospitalization can reduce opportunities for independent activity, choice, and control and may contribute to passivity, low mood, anxiety, and distress in some older adults. Zenctuary VR+ is a seated, nature-based virtual reality program that combines calming environments with simple, low-demand activities. The active program allows participants to make choices, move between predefined locations, and influence elements of the virtual environment. Trained staff supervise every session and provide support when needed.
The trial evaluates whether the interactive version of Zenctuary VR+ reduces psychological distress more than passive exposure to the same virtual environments. A total of 100 hospitalized adults aged 60 years or older will be randomly assigned to the interactive VR condition or the passive VR condition. Eligible participants are expected to remain hospitalized for at least four weeks following enrolment. Both groups will receive six sessions over three weeks. Psychological distress and related psychological factors will be assessed before the first session, immediately after the three-week intervention period, and four weeks after the final session.
Detailed Description
Background and Rationale
Prolonged hospitalization may substantially restrict opportunities for independent activity, personal choice, environmental influence, and participation in everyday routines. These restrictions may contribute to passivity, reduced motivation, diminished perceived control, anxiety, depressive symptoms, and broader psychological distress in some hospitalized older adults. Hospitalization does not necessarily result in learned helplessness; however, repeated experiences of limited control and weak action-outcome contingency may increase vulnerability to helplessness-related psychological processes.
Nature-based immersive virtual reality may provide access to calming and engaging environments when physical mobility or access to outdoor spaces is limited. Passive exposure to virtual natural environments may support relaxation, positive affect, attentional restoration, and temporary psychological distance from the hospital environment. Interactive virtual reality may provide an additional therapeutic component by allowing meaningful choices, successful actions, and immediate environmental consequences.
Zenctuary VR+ was developed as a mechanism-oriented, nature-based immersive virtual reality intervention for use in supervised clinical settings. The intervention combines restorative virtual environments with simple activities designed for hospitalized older adults, including participants with limited physical endurance, little or no previous virtual reality experience, or mild limitations in manual dexterity. The design emphasizes low cognitive demand, predictable interaction patterns, seated participation, gradual onboarding, and continuous operator support.
The proposed mechanism of action is based on repeated experiences of successful action and visible action-outcome contingency. An action initiated by a participant produces an immediate and understandable change in the virtual environment. Examples include selecting or manipulating an object, completing a simple care-related activity, influencing an environmental element, or choosing movement between predefined virtual locations. Repeated successful interactions may support perceived control, competence, self-efficacy, engagement, and subjective agency. These experiences may subsequently contribute to reduced passivity and psychological distress.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 60 years or older
- •Diagnosed with at least one chronic medical condition
- •Currently receiving inpatient hospital care
- •Expected to remain hospitalized for at least four weeks following enrolment
- •Physically able to use a head-mounted virtual reality device, as determined by the treating clinical team
- •Able to provide written informed consent
- •Able to complete study assessments and participate in the intervention procedures
Exclusion Criteria
- •Cognitive impairment, defined as a score below 18 on the Montreal Cognitive Assessment (MoCA)
- •Impaired consciousness or reduced alertness that would prevent meaningful participation
- •Current or previous diagnosis of a psychotic disorder
- •Current substance use disorder that would interfere with participation in the study procedures
- •Current treatment with antipsychotic medication
- •Untreated epilepsy
- •Severe vestibular dysfunction or recurrent vertigo
- •Any medical condition judged by the treating physician to make participation unsafe or inappropriate
Arms & Interventions
Active Zenctuary VR+ Intervention
Participants receive six sessions of the interactive, nature-based Zenctuary VR+ program over three weeks (twice weekly), delivered via head-mounted display (Meta Quest 3). The intervention includes low cognitive load interactive tasks (simple choices, navigation between virtual locations, and environmental interaction) designed to support agency, perceived control, and successful action while participants remain seated and supported by trained personnel.
Intervention: Interactive nature-based virtual reality intervention (Device)
Passive VR Control
Participants are exposed to the same nature-based virtual environments and head-mounted display (Meta Quest 3) as the active arm, following the same six-session, three-week schedule, but without interactive elements. Participants passively observe the virtual scenery, controlling for VR exposure and nature content while isolating the added effect of interactivity and agency-supporting features.
Intervention: Passive nature-based virtual reality exposure (Device)
Outcomes
Primary Outcomes
Change in Psychological Distress (Hospital Anxiety and Depression Scale total score)
Time Frame: Baseline (T0), immediately post-intervention (T1, after 3 weeks), and 4-week follow-up (T2)
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report instrument comprising two subscales assessing anxiety (HADS-A) and depression (HADS-D). The HADS total score (range 0-42, with higher scores indicating greater distress) will be compared between the active Zenctuary VR+ intervention group and the passive VR control group using a linear mixed model examining group-by-time effects.
Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale Total Score
Time Frame: Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session
The Hospital Anxiety and Depression Scale is a 14-item self-report measure comprising seven anxiety items and seven depression items. The total score ranges from 0 to 42, with higher scores indicating greater psychological distress.
Secondary Outcomes
- Change in Self-Esteem (Rosenberg Self-Esteem Scale)(Baseline (T0), immediately post-intervention (T1), and 4-week follow-up (T2))
- Change From Baseline in Self-Esteem as Measured by the Rosenberg Self-Esteem Scale(Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session)
- Change From Baseline in General Self-Efficacy as Measured by the General Self-Efficacy Scale(Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session)
- Change From Baseline in Depressive Symptoms as Measured by the Geriatric Depression Scale(Baseline and immediately after completion of the three-week intervention period)
- Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale(Baseline and immediately after completion of the three-week intervention period)