Psychological DistressZenctuaryVR+NCT07712549
Interactive Nature-Based Virtual Reality to Reduce Anxiety, Low Mood, and Feelings of Helplessness in Hospitalized Older Adults With Chronic Illness (Zenctuary VR+)
A study testing Interactive nature-based virtual reality intervention and Passive nature-based virtual reality exposure in people with Psychological Distress and Chronic Disease, run by Moholy-Nagy University of Art and Design at 3 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Psychological Distress, Chronic Disease, Learned Helplessness
- What is being tested?
- Interactive nature-based virtual reality intervention and Passive nature-based virtual reality exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesHungary
- Study dates
- 1 Nov 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary3 sites
Center for Geriatric Care and Nursing Science (Semmelweis University)
Budapest, 1097
Patrícia Lajkó, Drd psychologist, +36309874988, lajko.patricia@semmelweis.hu
Rehabilitation Clinic (Semmelweis University)
Budapest, 1121
Beáta Vásárhelyi, psychologist, +36203129800, vasarhelyi.beata.reka@semmelweis.hu
Department of Neurosurgery (University of Szeged)
Szeged, 6725
Mona Stankovic, PhD, +36 30 914 4787, stankovic.mona@med.u-szeged.hu
About this study
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
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.
Read the 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.
Training includes theoretical instruction and supervised practical use of both the active and passive intervention configurations. Personnel are required to demonstrate competency in the procedures relevant to their assigned role.
Intervention fidelity is supported through standardized virtual content, predefined active and passive configurations, operator training, structured session logs, study manuals, and regular coordination between participating centres.
Any protocol deviation, implementation problem, technical failure, use of operator assistance, missed session, early termination, or departure from the standardized procedure is documented and reviewed by the study coordination team.
Randomization and Allocation Concealment
Participants are assigned to the active or passive condition using a computer-generated randomization sequence. Randomization is performed after eligibility has been confirmed, written informed consent has been obtained, and baseline assessment has been completed.
The allocation sequence is prepared independently from participant recruitment, intervention delivery, and outcome assessment. Allocation information is restricted to personnel responsible for intervention scheduling and delivery.
Outcome assessors do not have access to the randomization sequence or treatment allocation. Allocation concealment is maintained until completion of baseline procedures and assignment to a study condition.
Blinding
Participant and operator blinding is not feasible because interactive and passive virtual reality experiences are perceptibly different.
Outcome assessments are conducted by trained personnel who are not involved in intervention delivery and remain unaware of treatment allocation. Participants are asked not to disclose details of the assigned condition during assessment procedures.
Role separation between intervention operators and outcome assessors is maintained whenever possible. The same staff member does not both deliver the intervention and conduct outcome assessment for the same participant.
Any accidental disclosure of allocation to an outcome assessor is documented as a protocol deviation. Coded group labels may be used during statistical analysis to reduce analysis-related bias.
Outcome Assessment
Psychological outcomes are assessed at baseline, immediately after the three-week intervention period, and at four-week follow-up according to the predefined measurement schedule.
The primary outcome is overall psychological distress. Secondary outcomes examine self-esteem, general self-efficacy, hopelessness, and depressive symptoms. Exploratory outcomes include separate anxiety and depression symptom dimensions and learned helplessness-related processes.
Questionnaire administration may be divided across more than one assessment session when required to reduce participant burden. When an assessment is divided, the component sessions are completed within the protocol-defined time window.
Follow-up assessment is conducted in person whenever feasible. When a participant has been discharged before follow-up, assessment may be conducted through a structured telephone interview if separate consent for follow-up contact has been provided and the relevant measure is appropriate for telephone administration.
Qualitative Post-Session Interviews
Brief semi-structured interviews are conducted after each virtual reality session in both study conditions. The interviews are designed to capture participants' immediate experiences and responses to the session.
Core topics include emotional responses, perceived benefits, discomfort, difficulties, barriers to engagement, intervention acceptability, perceived control, and experiences associated with active participation or passive observation.
The same core interview structure is used in both conditions, with minor wording adaptations reflecting the assigned virtual reality experience. Questions are formulated to avoid assuming that a benefit, difficulty, or psychological change has occurred.
Exploratory attention is given to agency-related experiences, including references to choice, self-initiated action, environmental influence, successful action, competence, limitation, passivity, dependence on operator assistance, and perceived inability to influence the experience.
A final semi-structured interview is conducted after the sixth session. The final interview explores the overall experience across the intervention period, perceived changes over time, memorable aspects of the virtual environments, acceptability of repeated participation, and future-oriented reflections associated with the sessions.
Where separate consent is provided, interviews may be audio-recorded to support accurate transcription and analysis. When audio recording is unavailable or is not consented to, qualitative information is documented through structured written notes or summaries.
Operators also complete structured session notes concerning participant engagement, assistance, interruptions, notable verbal or behavioural responses, tolerability, technical difficulties, and procedural adaptations. Operator notes are treated as complementary implementation and contextual data rather than as substitutes for participant interviews.
Qualitative Analysis
Qualitative interview data are analyzed using thematic analysis. The analysis identifies recurring patterns related to participant experience, emotional responses, perceived benefits, difficulties, barriers to use, acceptability, engagement, and differences between active participation and passive observation.
Agency-related patterns are examined exploratorily, including experiences of choice, self-initiated action, successful action, environmental control, passivity, limitation, help-seeking, operator dependence, and future-oriented intentions.
The analysis is intended to contextualize the quantitative trial outcomes, explore the acceptability and experiential effects of the intervention, and examine the plausibility of the hypothesized agency-related mechanisms.
Qualitative findings are interpreted as exploratory and are not used as confirmatory evidence of intervention effectiveness. The analysis does not replace the prespecified quantitative comparison between study conditions.
Qualitative data may be reported in a separate publication from the primary randomized controlled trial results. Separate reporting does not alter the prespecified status of the qualitative data collection and thematic analysis within the overall study protocol.
Safety and Tolerability
All sessions are conducted with participants seated and under continuous operator supervision. Screening procedures are used to identify clinical conditions that may make immersive virtual reality use unsafe or inappropriate.
The physical area around the participant is kept clear and suitable for supervised headset use. The headset and controllers are checked before each session and cleaned between participants according to institutional hygiene procedures.
Operators continuously monitor participants for nausea, dizziness, headache, visual discomfort, fatigue, disorientation, anxiety, emotional distress, attempts to stand, or any other sign of intolerance.
A session is paused or terminated immediately when clinically indicated or upon participant request. Participants may request termination at any point without providing a reason.
Virtual movement is limited to controlled transitions between predefined locations. Continuous artificial locomotion is not used. Predictable scene structure, gradual transitions, seated use, low task complexity, session-duration limits, operator monitoring, and immediate operator override serve as technical and procedural risk-control measures.
Adverse events, discomfort, near-falls, interruptions, incomplete sessions, early terminations, and technical incidents are recorded according to the study safety procedures.
Participation may be temporarily interrupted or permanently discontinued when continued virtual reality exposure is considered unsafe, poorly tolerated, clinically inappropriate, or inconsistent with participant preference.
Data Quality and Management
Study data are collected using standardized case report forms, assessment materials, session logs, and interview documentation procedures.
Participants are identified in the research dataset using coded study identifiers. Direct personal identifiers are stored separately from research data and are accessible only to authorized personnel.
Access to allocation information, outcome data, qualitative materials, and identifying information is restricted according to study roles and institutional data-protection procedures.
Data quality is supported through standardized training, predefined data-entry rules, review of missing or inconsistent data, documentation of corrections, and regular coordination between participating centres.
Analytical Approach
The primary analysis evaluates whether change in psychological distress differs between the active and passive conditions across the assessment period.
Repeated observations are analyzed using a longitudinal modelling approach that accounts for correlation between measurements obtained from the same participant and allows inclusion of participants with partially incomplete outcome data under the assumptions of the selected model.
The principal analysis follows the intention-to-treat principle. Secondary and mechanism-related quantitative analyses are considered exploratory and are interpreted with appropriate caution.
Interpretation focuses on estimated between-group differences, change over time, uncertainty around effect estimates, consistency across assessment points, and correspondence between primary, secondary, exploratory, and qualitative findings.
The trial is designed to determine whether adding simple, agency-supporting interaction to nature-based immersive virtual reality produces psychological benefits beyond passive exposure to the same virtual environments.
The study also examines the feasibility of delivering a standardized, supervised, low-demand virtual reality intervention across multiple inpatient clinical settings and explores how hospitalized older adults experience active and passive forms of immersive nature exposure.
- Being tested
- Interactive nature-based virtual reality intervention, Passive nature-based virtual reality exposure
- Keywords
- Virtual reality, Randomized controlled trial, Digital health intervention, Nature exposure, Self-efficacy, Older adults, Learned helplessness, Psychological distress
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive nature-based virtual reality interventionDevice
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 approach.
Passive nature-based virtual reality exposureDevice
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 interactivity.
| Study group | Role | What they receive |
|---|---|---|
| Active Zenctuary VR+ Intervention | Experimental | 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. Receives: Device: Interactive nature-based virtual reality intervention |
| Passive VR Control | Active comparator | 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. Receives: Device: Passive nature-based virtual reality exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale Total Score
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.
Measured: Baseline; immediately after completion of the three-week intervention period; and four weeks after the final intervention session
Secondary outcomes (4)
Change From Baseline in Self-Esteem as Measured by the Rosenberg Self-Esteem Scale
The Rosenberg Self-Esteem Scale is a 10-item self-report measure of global self-esteem. The total score ranges from 0 to 30, with higher scores indicating higher self-esteem.
Measured: 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
The General Self-Efficacy Scale is a 10-item self-report measure assessing perceived ability to manage difficult or novel situations. The total score ranges from 10 to 40, with higher scores indicating greater general self-efficacy.
Measured: 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
The 30-item Geriatric Depression Scale is a self-report measure of depressive symptoms in older adults. The total score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.
Measured: Baseline and immediately after completion of the three-week intervention period
Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale
The Beck Hopelessness Scale is a 20-item self-report measure assessing negative expectations and beliefs about the future. The total score ranges from 0 to 20, with higher scores indicating greater hopelessness.
Measured: Baseline and immediately after completion of the three-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moholy-Nagy University of Art and Design
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ágnes Bakk, PhD, Principal investigator, Moholy-Nagy University of Art and Design
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712549
- Sponsor's protocol ID
- NNGYK/27626-8/2026
- Other IDs
- 2024-1.2.3-HU-RIZONT202400103
- Acronym
- ZenctuaryVR+
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data collected in this trial will not be shared with researchers outside the study consortium. The dataset includes sensitive health information from a vulnerable population of hospitalized older adults with chronic and complex medical conditions, including cognitive screening results (Montreal Cognitive Assessment), psychological distress measures, and clinical data linked to inpatient care at the participating hospital sites. Data are collected and managed within a secure database accessible only to authorized study personnel. At this stage, no data sharing infrastructure, external access governance, or participant consent provisions for third-party data sharing have been established. A decision regarding future IPD sharing may be reconsidered following completion of the trial and in accordance with applicable data protection regulations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07712549
- Acronym / sponsor ID
- ZenctuaryVR+ / NNGYK/27626-8/2026
- Keywords
- Virtual reality, Randomized controlled trial, Digital health intervention, Nature exposure, Self-efficacy, Older adults, Learned helplessness, Psychological distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Moholy-Nagy University of Art and DesignUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Training includes theoretical instruction and supervised practical use of both the active and passive intervention configurations. Personnel are required to demonstrate competency in the procedures relevant to their assigned role.
Intervention fidelity is supported through standardized virtual content, predefined active and passive configurations, operator training, structured session logs, study manuals, and regular coordination between participating centres.
Any protocol deviation, implementation problem, technical failure, use of operator assistance, missed session, early termination, or departure from the standardized procedure is documented and reviewed by the study coordination team.
Randomization and Allocation Concealment
Participants are assigned to the active or passive condition using a computer-generated randomization sequence. Randomization is performed after eligibility has been confirmed, written informed consent has been obtained, and baseline assessment has been completed.
The allocation sequence is prepared independently from participant recruitment, intervention delivery, and outcome assessment. Allocation information is restricted to personnel responsible for intervention scheduling and delivery.
Outcome assessors do not have access to the randomization sequence or treatment allocation. Allocation concealment is maintained until completion of baseline procedures and assignment to a study condition.
Blinding
Participant and operator blinding is not feasible because interactive and passive virtual reality experiences are perceptibly different.
Outcome assessments are conducted by trained personnel who are not involved in intervention delivery and remain unaware of treatment allocation. Participants are asked not to disclose details of the assigned condition during assessment procedures.
Role separation between intervention operators and outcome assessors is maintained whenever possible. The same staff member does not both deliver the intervention and conduct outcome assessment for the same participant.
Any accidental disclosure of allocation to an outcome assessor is documented as a protocol deviation. Coded group labels may be used during statistical analysis to reduce analysis-related bias.
Outcome Assessment
Psychological outcomes are assessed at baseline, immediately after the three-week intervention period, and at four-week follow-up according to the predefined measurement schedule.
The primary outcome is overall psychological distress. Secondary outcomes examine self-esteem, general self-efficacy, hopelessness, and depressive symptoms. Exploratory outcomes include separate anxiety and depression symptom dimensions and learned helplessness-related processes.
Questionnaire administration may be divided across more than one assessment session when required to reduce participant burden. When an assessment is divided, the component sessions are completed within the protocol-defined time window.
Follow-up assessment is conducted in person whenever feasible. When a participant has been discharged before follow-up, assessment may be conducted through a structured telephone interview if separate consent for follow-up contact has been provided and the relevant measure is appropriate for telephone administration.
Qualitative Post-Session Interviews
Brief semi-structured interviews are conducted after each virtual reality session in both study conditions. The interviews are designed to capture participants' immediate experiences and responses to the session.
Core topics include emotional responses, perceived benefits, discomfort, difficulties, barriers to engagement, intervention acceptability, perceived control, and experiences associated with active participation or passive observation.
The same core interview structure is used in both conditions, with minor wording adaptations reflecting the assigned virtual reality experience. Questions are formulated to avoid assuming that a benefit, difficulty, or psychological change has occurred.
Exploratory attention is given to agency-related experiences, including references to choice, self-initiated action, environmental influence, successful action, competence, limitation, passivity, dependence on operator assistance, and perceived inability to influence the experience.
A final semi-structured interview is conducted after the sixth session. The final interview explores the overall experience across the intervention period, perceived changes over time, memorable aspects of the virtual environments, acceptability of repeated participation, and future-oriented reflections associated with the sessions.
Where separate consent is provided, interviews may be audio-recorded to support accurate transcription and analysis. When audio recording is unavailable or is not consented to, qualitative information is documented through structured written notes or summaries.
Operators also complete structured session notes concerning participant engagement, assistance, interruptions, notable verbal or behavioural responses, tolerability, technical difficulties, and procedural adaptations. Operator notes are treated as complementary implementation and contextual data rather than as substitutes for participant interviews.
Qualitative Analysis
Qualitative interview data are analyzed using thematic analysis. The analysis identifies recurring patterns related to participant experience, emotional responses, perceived benefits, difficulties, barriers to use, acceptability, engagement, and differences between active participation and passive observation.
Agency-related patterns are examined exploratorily, including experiences of choice, self-initiated action, successful action, environmental control, passivity, limitation, help-seeking, operator dependence, and future-oriented intentions.
The analysis is intended to contextualize the quantitative trial outcomes, explore the acceptability and experiential effects of the intervention, and examine the plausibility of the hypothesized agency-related mechanisms.
Qualitative findings are interpreted as exploratory and are not used as confirmatory evidence of intervention effectiveness. The analysis does not replace the prespecified quantitative comparison between study conditions.
Qualitative data may be reported in a separate publication from the primary randomized controlled trial results. Separate reporting does not alter the prespecified status of the qualitative data collection and thematic analysis within the overall study protocol.
Safety and Tolerability
All sessions are conducted with participants seated and under continuous operator supervision. Screening procedures are used to identify clinical conditions that may make immersive virtual reality use unsafe or inappropriate.
The physical area around the participant is kept clear and suitable for supervised headset use. The headset and controllers are checked before each session and cleaned between participants according to institutional hygiene procedures.
Operators continuously monitor participants for nausea, dizziness, headache, visual discomfort, fatigue, disorientation, anxiety, emotional distress, attempts to stand, or any other sign of intolerance.
A session is paused or terminated immediately when clinically indicated or upon participant request. Participants may request termination at any point without providing a reason.
Virtual movement is limited to controlled transitions between predefined locations. Continuous artificial locomotion is not used. Predictable scene structure, gradual transitions, seated use, low task complexity, session-duration limits, operator monitoring, and immediate operator override serve as technical and procedural risk-control measures.
Adverse events, discomfort, near-falls, interruptions, incomplete sessions, early terminations, and technical incidents are recorded according to the study safety procedures.
Participation may be temporarily interrupted or permanently discontinued when continued virtual reality exposure is considered unsafe, poorly tolerated, clinically inappropriate, or inconsistent with participant preference.
Data Quality and Management
Study data are collected using standardized case report forms, assessment materials, session logs, and interview documentation procedures.
Participants are identified in the research dataset using coded study identifiers. Direct personal identifiers are stored separately from research data and are accessible only to authorized personnel.
Access to allocation information, outcome data, qualitative materials, and identifying information is restricted according to study roles and institutional data-protection procedures.
Data quality is supported through standardized training, predefined data-entry rules, review of missing or inconsistent data, documentation of corrections, and regular coordination between participating centres.
Analytical Approach
The primary analysis evaluates whether change in psychological distress differs between the active and passive conditions across the assessment period.
Repeated observations are analyzed using a longitudinal modelling approach that accounts for correlation between measurements obtained from the same participant and allows inclusion of participants with partially incomplete outcome data under the assumptions of the selected model.
The principal analysis follows the intention-to-treat principle. Secondary and mechanism-related quantitative analyses are considered exploratory and are interpreted with appropriate caution.
Interpretation focuses on estimated between-group differences, change over time, uncertainty around effect estimates, consistency across assessment points, and correspondence between primary, secondary, exploratory, and qualitative findings.
The trial is designed to determine whether adding simple, agency-supporting interaction to nature-based immersive virtual reality produces psychological benefits beyond passive exposure to the same virtual environments.
The study also examines the feasibility of delivering a standardized, supervised, low-demand virtual reality intervention across multiple inpatient clinical settings and explores how hospitalized older adults experience active and passive forms of immersive nature exposure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Zenctuary VR+ Intervention | Experimental | Device: Interactive nature-based virtual reality interventionParticipants 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. |
| Passive VR Control | Active comparator | Device: Passive nature-based virtual reality exposureParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive nature-based virtual reality interventionAn 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 approach. | Device | Active Zenctuary VR+ Intervention |
| Passive nature-based virtual reality exposureAn 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 interactivity. | Device | Passive VR Control |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- ZenctuaryVR+ project No. 2024-1.2.3-HU-RIZONT-2024-00103, supported by the National Research, Development and Innovation Fund of the Ministry of Culture and Innovation, financed under the 2024-1.2.3-HU-RIZONT call for proposals.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data collected in this trial will not be shared with researchers outside the study consortium. The dataset includes sensitive health information from a vulnerable population of hospitalized older adults with chronic and complex medical conditions, including cognitive screening results (Montreal Cognitive Assessment), psychological distress measures, and clinical data linked to inpatient care at the participating hospital sites. Data are collected and managed within a secure database accessible only to authorized study personnel. At this stage, no data sharing infrastructure, external access governance, or participant consent provisions for third-party data sharing have been established. A decision regarding future IPD sharing may be reconsidered following completion of the trial and in accordance with applicable data protection regulations and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ágnes Bakk, PhD principal investigator
Moholy-Nagy University of Art and Design
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive nature-based virtual reality intervention and Passive nature-based virtual reality exposure in people with Psychological Distress and Chronic Disease, run by Moholy-Nagy University of Art and Design at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pál Tamás Szabó, PhD (+36301292315, szabo.pal@mome.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.