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Interactive Nature-Based Virtual Reality to Reduce Anxiety, Low Mood, and Feelings of Helplessness in Hospitalized Older Adults With Chronic Illness (Zenctuary VR+)

No phase Interventional Psychological Distress Chronic Disease Learned Helplessness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interactive nature-based virtual reality intervention, Passive nature-based virtual reality exposure.
Who it may be relevant to
Registry conditions: Psychological Distress, Chronic Disease, Learned Helplessness. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 Objectives

The primary objective is to determine whether the active, interactive Zenctuary VR+ intervention produces a greater reduction in psychological distress than passive exposure to the same nature-based virtual environments.

Secondary objectives are to examine changes in psychological constructs related to adaptation, perceived competence, hopelessness, depressive symptoms, and helplessness-related processes.

Exploratory objectives include examination of anxiety and depression symptom dimensions separately, investigation of learned helplessness-related processes, and qualitative exploration of participant experience, intervention acceptability, engagement, perceived control, choice, successful action, passivity, and barriers to participation.

Study Design

The study is a multicentre, parallel-group, assessor-blinded randomized controlled trial conducted in inpatient hospital settings in Hungary. Hospitalized adults aged 60 years or older are randomly assigned in equal proportions to an active, interactive virtual reality condition or a passive virtual reality control condition.

Both study conditions use the same type of virtual reality hardware, the same nature-based virtual environments, comparable audiovisual content, the same session schedule, similar exposure duration, and the same general level of operator supervision. The principal prespecified difference between the conditions is the availability of participant-controlled navigation and interaction.

The study design is intended to distinguish the potential effect of agency-supporting interaction from the broader effects of immersive nature exposure, novelty, repeated study contact, staff attention, and virtual reality use. Comparison of the two conditions therefore evaluates whether interactive features provide additional psychological benefit beyond passive exposure to the same virtual environments.

Assessments are conducted before the intervention period, immediately after completion of the intervention period, and at follow-up. The primary outcome concerns change in overall psychological distress. Secondary and exploratory assessments examine psychological constructs related to self-esteem, self-efficacy, hopelessness, depressive symptoms, anxiety, and learned helplessness-related processes.

Zenctuary VR+ System

Zenctuary VR+ is delivered using a Meta Quest 3 head-mounted display with handheld controllers. The system also includes a local operator interface running on a compatible mobile or tablet device. Communication between the headset and the operator interface occurs through a local network and does not require an internet connection during clinical use.

The virtual content consists of structured nature-based environments containing predefined locations and activity points. Movement between virtual locations is limited to controlled transitions rather than continuous artificial locomotion. Controlled transitions, seated use, predictable scene structure, and stable visual presentation are intended to reduce visual-vestibular mismatch, disorientation, and cybersickness risk.

Interactive activities are constructed from a small number of consistent interaction primitives, including selecting, activating, holding, moving, releasing, and observing virtual elements. Tasks are designed to remain achievable without previous virtual reality experience. Activities do not require standing, walking, rapid responses, complex sequences, extensive memorization, or precise fine-motor control.

The virtual environments include calming natural scenery, ambient sound, predefined observation points, and simple activities based on interaction with objects, animals, or environmental elements. The intervention is not designed as a competitive or performance-based game. Speed, scoring, rankings, penalties, and repeated failure are not emphasized.

Active Virtual Reality Condition

The active condition provides access to participant-controlled navigation and interactive virtual elements. Participants can make choices, move between predefined locations, manipulate objects, and influence events within the virtual environment.

Activities are intentionally simple and low demand. The interaction design emphasizes understandable goals, achievable actions, visible consequences, and immediate environmental feedback. Responses to participant actions may include object movement, sound, animation, scene changes, or completion of a simple activity.

The active condition is designed to provide repeated experiences in which an intentional action produces a clear and predictable outcome. These action-outcome experiences are hypothesized to support agency, perceived control, competence, successful action, and engagement.

The active intervention may include activities involving simple object manipulation, observation, care-related actions, environmental influence, and movement between predefined virtual locations. Activities are completed while the participant remains seated.

Operators provide assistance according to a standardized least-assistance approach. Initial support consists of brief verbal clarification or reassurance. Additional task-specific guidance is provided only when required. Direct operator-supported navigation or interaction is used only when lower levels of assistance are insufficient or when additional support is required for safety, accessibility, technical reasons, or task comprehension.

Passive Virtual Reality Control Condition

The passive condition uses the same nature-based virtual environments and comparable audiovisual content without participant-controlled navigation or interactive activities. Interactive elements are disabled, and virtual exposure is organized around predefined observation locations.

Participants observe the virtual environment while remaining seated and continuously supervised. No task completion, environmental manipulation, participant-controlled movement, or interactive choice is required.

The passive condition preserves immersive nature exposure, headset use, visual and auditory stimulation, repeated session contact, and operator presence while removing the primary agency-supporting components of the active intervention.

The control condition is therefore an active comparator rather than a no-treatment condition. The passive experience may itself provide relaxation, distraction, positive affect, or psychological distance from the hospital environment. The trial evaluates whether participant-controlled interaction and navigation provide benefits beyond these shared effects.

Session Schedule and Delivery

Both conditions receive six individual virtual reality sessions over a three-week intervention period. Sessions are conducted twice weekly under the supervision of trained study personnel.

Each session follows a standardized structure. The session begins with a brief pre-session safety and comfort check, confirmation that the participant is clinically able to proceed, and preparation of the headset and physical environment. The participant remains seated in a stable and supported position throughout the virtual reality experience.

Standardized onboarding is completed before virtual exposure. Onboarding includes an explanation of the session procedure, adjustment of the head-mounted display, introduction to the controller when applicable, explanation of the assigned interaction mode, and confirmation that the session can be paused or stopped at any time.

Session duration is adjusted within the protocol-defined range according to the participant's clinical condition, comfort, fatigue, attention, and tolerance. A session may be shortened, paused, rescheduled, or terminated when clinically appropriate.

The operator monitors the participant and the virtual environment throughout the session. The local operator interface supports real-time observation, scene selection, location selection, navigation support, interaction support, technical troubleshooting, and immediate session termination.

Operator assistance, interruptions, technical problems, incomplete activities, early termination, adverse reactions, and relevant participant responses are documented in a standardized session log.

Intervention Standardization and Fidelity

All participating centres follow the same study manual, operator instructions, onboarding procedures, session structure, safety criteria, documentation requirements, and intervention configurations.

Personnel responsible for intervention delivery complete study-specific training before participant enrolment. Training covers system setup, headset fitting, operator-interface use, participant onboarding, graded assistance, recognition of discomfort, cybersickness monitoring, emergency termination, equipment hygiene, session documentation, and adverse-event procedures.

Interventions

  • Device Interactive nature-based virtual reality intervention
    An immersive, head-mounted-display-delivered virtual reality intervention presenting nature-based virtual environments with interactive, low cognitive load tasks. Participants make simple choices, navigate between virtual locations, and influence elements of the environment while seated, with the goal of supporting agency, perceived control, and successful action. Delivered in six sessions over three weeks (twice weekly), each guided by a trained operator using a standardized least-assistance ap
  • Device Passive nature-based virtual reality exposure
    An immersive, head-mounted-display-delivered virtual reality experience presenting the same nature-based virtual environments as the active intervention, without interactive elements. Participants passively observe the virtual scenery while seated, with no opportunity for choice, navigation, or environmental interaction. Delivered in six sessions over three weeks (twice weekly), matching the active intervention in schedule, apparatus, and visual content, differing only in the absence of interact

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Change From Baseline in Self-Esteem as Measured by the Rosenberg Self-Esteem Scale [Time frame: 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 [Time frame: 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 [Time frame: Baseline and immediately after completion of the three-week intervention period]
  • Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale [Time frame: Baseline and immediately after completion of the three-week intervention period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Hungary · 3 centers
  • Center for Geriatric Care and Nursing Science (Semmelweis University) — Budapest
  • Rehabilitation Clinic (Semmelweis University) — Budapest
  • Department of Neurosurgery (University of Szeged) — Szeged

Identifiers

NCT: NCT07712549 · NNGYK/27626-8/2026 · 2024-1.2.3-HU-RIZONT202400103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗