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| ID | Type | Description | Link |
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| 2024-1.2.3-HU-RIZONT202400103 | Other Grant/Funding Number | National Research, Development and Innovation Fund of the Ministry of Culture and Innovation |
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This study tests whether an interactive, nature-based virtual reality (VR) program can help reduce anxiety and depression in older adults staying in the hospital with chronic health conditions. Long hospital stays can leave patients feeling like they have little control over their daily routine, which may contribute to passivity, low mood, and distress. The Zenctuary VR+ program lets participants interact with calming nature scenes (making simple choices, moving between locations, influencing what they see) while seated and supported by trained staff, with the goal of helping them experience a sense of control and successful action.
The study asks: Does an interactive, agency-supporting VR experience reduce psychological distress more than simply watching the same nature scenes passively? 100 hospitalized adults aged 60 and older, across three hospital departments in Hungary, will be randomly assigned to either the interactive VR program or a passive VR condition (same virtual environments, but without interactive elements). Both groups will receive six VR sessions over three weeks. Researchers will measure anxiety and depression, along with related factors like self-esteem, self-efficacy, hopelessness, and feelings of helplessness, before the program, right after it ends, and four weeks later, to see whether the interactive version provides added benefit beyond nature exposure alone.
Background Prolonged hospitalization in older adults may contribute to reduced autonomy, passivity, diminished perceived control, and psychological distress. Although hospitalization does not necessarily lead to learned helplessness, it may create conditions that increase vulnerability to helplessness-related processes in some patients, particularly when opportunities for self-directed action and visible action-outcome contingencies are limited. Immersive virtual reality (VR) may offer opportunities for safe, accessible, and meaningful interaction in otherwise constrained hospital environments; however, the added value of interactive, agency-supporting VR components remains insufficiently studied in hospitalized older adults.
Objective This study aims to evaluate the effectiveness of Zenctuary VR+, a mechanism-oriented, nature-based immersive VR intervention, in reducing psychological distress among hospitalized older adults compared with a passive VR control condition. Secondary aims are to explore changes in learned helplessness-related constructs, including self-efficacy, self-esteem, hopelessness, depressive symptoms, and learned helplessness.
Methods and analysis This is a multicentre, parallel-group, assessor-blinded randomized controlled trial conducted in inpatient hospital settings in Hungary. A total of 100 hospitalized adults aged 60 years or older will be randomly assigned in a 1:1 ratio to either the active Zenctuary VR+ intervention or a passive VR control condition. Both groups will receive six VR sessions over three weeks, delivered twice weekly using the same head-mounted display and the same nature-based virtual environments. The active intervention includes low cognitive load interactive tasks designed to support agency, perceived control, and successful action, whereas the control condition involves passive observation of the same virtual environments without interactive elements. Assessments will be conducted at baseline, post-intervention, and four-week follow-up. The primary outcome is psychological distress measured by the Hospital Anxiety and Depression Scale total score. The primary analysis will use a linear mixed model to examine group-by-time effects. Secondary and mechanism-related analyses will be considered exploratory.
Ethics and dissemination The study has received national ethical and regulatory approval in Hungary from the National Centre for Public Health and Pharmacy. ClinicalTrials.gov registration is currently in progress. Results will be disseminated through peer-reviewed publications, conference presentations, and project-related dissemination activities.
Trial registration ClinicalTrials.gov registration pending. Keywords virtual reality, hospitalized older adults, learned helplessness, psychological distress, agency, perceived control, randomized controlled trial, digital health
Introduction 1.1 Background and rationale Older adults undergoing prolonged hospitalization are at increased risk of functional and psychological decline. Beyond the direct effects of illness, hospitalization may restrict autonomy, reduce opportunities for self-directed activity, and place patients in a more passive role. For older adults with chronic and complex health conditions, the hospital environment may therefore contribute not only to reduced activity, but also to diminished perceived control, lower motivation, and increased psychological distress. These effects are not universal or inevitable; rather, hospitalization may create conditions that increase vulnerability to helplessness-related processes in some patients, particularly when daily routines, mobility, treatment-related decisions, and environmental conditions are largely externally regulated. Anxiety and depressive symptoms are common in hospital settings and may interfere with rehabilitation, treatment engagement, and overall well-being.
The concept of learned helplessness provides a useful theoretical framework for interpreting these processes without assuming that hospitalization automatically produces learned helplessness. Learned helplessness refers to a psychological state in which repeated experiences of uncontrollability or non-contingency between action and outcome lead to passivity, reduced initiative, motivational decline, and depressive responses. In hospitalized older adults, repeated experiences of limited influence over daily routines and the physical or social environment may contribute to reduced perceived control and agency. From this perspective, psychological distress in hospital settings may partly reflect constrained autonomy and limited opportunities to experience meaningful action, especially among patients exposed to prolonged dependency or uncertainty regarding recovery.
Interventions that restore even small forms of choice, control, and successful action may therefore be clinically relevant. Previous work on perceived control, self-efficacy, and autonomy in older adults suggests that structured opportunities for choice and personal influence can support engagement and well-being. This is particularly important in clinical contexts where patients may experience dependency, functional limitations, or uncertainty regarding recovery. Accordingly, interventions for hospitalized older adults should not only aim to reduce symptoms, but also create conditions in which patients can experience competence, agency, and meaningful engagement.
Virtual reality (VR) offers a promising approach for this purpose. VR can provide access to safe, engaging, and controllable environments even when physical mobility and access to natural surroundings are limited. Nature-based VR environments may support emotional regulation, relaxation, and positive affect, while interactive VR systems can additionally provide opportunities for exploration, choice, and environmental influence. However, the potential benefits of VR are not automatic. Older and clinically vulnerable users may experience uncertainty, cognitive overload, anxiety, or discomfort during initial encounters with immersive technology. For this reason, VR interventions designed for hospitalized older adults require careful attention to usability, onboarding, safety, and cognitive load.
Zenctuary VR+ is a nature-based VR intervention developed for older adults in clinical settings. It builds on the earlier Zenctuary VR concept and extends it into a more structured intervention designed to provide low cognitive load, accessible, and meaningful interactions within a safe virtual environment. Its core design rationale is mechanism-oriented: rather than offering passive exposure to pleasant virtual scenery alone, Zenctuary VR+ aims to provide repeated opportunities for successful action, perceived control, and agency. Participants can engage in simple interaction tasks, navigate between virtual locations, and influence elements of the environment while remaining seated and supported by trained personnel. These features are hypothesized to address helplessness-related processes that may emerge in response to prolonged dependency, reduced autonomy, and limited opportunities for self-directed action during hospitalization.
The hypothesized mechanism of action is based on the assumption that repeated, low-demand successful actions may strengthen the perceived link between action and outcome. When participants interact with the virtual environment and observe the immediate consequences of their actions, these experiences may support perceived control and the subjective sense of agency. Repeated experiences of successful action may subsequently contribute to self-efficacy, understood as confidence in one's ability to perform actions and influence outcomes. In this framework, Zenctuary VR+ is hypothesized to target helplessness-related processes not by directly treating learned helplessness as a fixed condition, but by providing structured opportunities for action, choice, and mastery that may reduce passivity and psychological distress.
The present study is a multicentre randomized controlled trial evaluating the effectiveness of Zenctuary VR+ among hospitalized older adults. The trial compares an active, interactive VR intervention with a passive VR control condition using the same virtual environments but without interactive elements. This design allows the study to examine whether interaction and agency-supporting features provide additional benefit beyond immersive nature exposure alone.
[Figure 1: Conceptual mechanism model, to be inserted] 1.2 Objectives Primary objective To determine whether the active Zenctuary VR+ intervention reduces psychological distress, measured by the total score of the Hospital Anxiety and Depression Scale (HADS), compared with passive VR exposure.
Secondary objectives To explore changes in learned helplessness-related constructs, including self-efficacy, self-esteem, hopelessness, depressive symptoms, and learned helplessness.
Hypotheses Primary hypothesis: Participants receiving the active Zenctuary VR+ intervention will demonstrate a greater reduction in psychological distress compared with participants allocated to the passive VR control condition.
Secondary hypothesis: Changes in learned helplessness-related psychological constructs may help explain the effect of the intervention on psychological distress.
Methods, Materials and Analysis 2.1 Study design This study is a multicentre, parallel-group, randomized controlled trial designed to evaluate the effectiveness of a mechanism-oriented, nature-based immersive virtual reality (VR) intervention (Zenctuary VR+) in reducing psychological distress among hospitalized older adults. Participants will be randomly allocated in a 1:1 ratio to either an active VR intervention group or a passive VR control group.
The trial will employ an assessor-blinded design. Due to the nature of the intervention, participant blinding is not feasible. Outcome assessments will be conducted by trained research personnel who are not involved in intervention delivery and remain unaware of participants' group allocation.
The active intervention consists of an interactive nature-based VR experience designed to promote agency, perceived control, and engagement through low cognitive load activities. The control condition involves exposure to the same virtual environments without interactive elements, allowing participants to passively observe the virtual scenery.
The study follows a repeated-measures design with assessments conducted at baseline (T0), immediately following the intervention period (T1), and at a four-week follow-up assessment (T2).
This protocol was prepared in accordance with the SPIRIT 2025 Statement for randomized trial protocols. A completed SPIRIT checklist mapping the relevant protocol items to the corresponding manuscript sections will be provided as Supplementary Table 1.
2.2 Study setting This multicentre study will be conducted in inpatient hospital settings in Hungary. Participant recruitment and intervention delivery will take place at collaborating clinical sites providing care for older adults with chronic and complex health conditions. The participating sites include the Department of Rehabilitation Medicine and the Department of Geriatrics and Nursing Science at Semmelweis University, and the Department of Neurosurgery at the University of Szeged.
Participating sites are inpatient clinical centres with the capacity to support recruitment, informed consent procedures, intervention delivery, safety monitoring, and follow-up data collection. Participants will be recruited from inpatient wards in collaboration with treating physicians and clinical staff.
All study procedures, including screening, informed consent, intervention delivery, outcome assessment, and safety monitoring, will be performed on-site within the participating institutions. The intervention will be delivered individually using a head-mounted virtual reality display (Meta Quest 3) under the supervision of trained study personnel. Intervention operators will be required to complete study-specific training before delivering VR sessions.
All participating sites will follow the same study manual, safety procedures, data collection forms, and reporting requirements, to ensure consistency in recruitment, intervention delivery, data collection, follow-up procedures, and safety reporting across all centres.
2.3 Study duration and participant timeline The study is planned to commence in November 2026 and conclude in December 2027. Participant recruitment, intervention delivery, follow-up assessments, and data collection will be conducted throughout this period.
Each participant will take part in the study for approximately seven weeks: a three-week intervention period plus a four-week follow-up period after the final VR session. Following eligibility screening and baseline assessment (T0), participants will undergo a three-week intervention period consisting of six VR sessions delivered twice weekly. Post-intervention assessments will be conducted immediately after completion of the intervention period (T1). A follow-up assessment (T2) will be performed four weeks after the final intervention session to evaluate the persistence of intervention effects.
Outcome measures will be collected at three predefined time points: baseline (T0), post-intervention (T1), and four-week follow-up (T2). To reduce participant burden, particularly among hospitalized older adults with limited physical or cognitive endurance, questionnaire administration may be divided across two separate assessment sessions occurring within a maximum interval of 48 hours.
[Figure 3: Planned participant flow and randomized trial schema, to be inserted. Table 1: Detailed schedule of enrolment, intervention delivery, assessments, session-level monitoring, and follow-up, to be inserted.] 2.4 Patient and public involvement The development of Zenctuary VR+ was informed by participatory and practice-based development activities involving older adults, clinical stakeholders, and interdisciplinary design and research team members. Feedback from preparatory workshops, usability testing, and clinical consultations informed the design of the virtual environments, interaction logic, onboarding procedures, safety considerations, and operator-assisted accessibility features.
Patient and user input contributed particularly to the simplification of interaction demands, the development of preparatory onboarding procedures, the refinement of safety communication, and the emphasis on seated, low cognitive load participation. Although patients and members of the public will not be involved in randomization, outcome assessment, or statistical analysis, their earlier input shaped the intervention design and implementation procedures. Findings from the trial will be disseminated through scientific publications, conference presentations, and project-related dissemination activities.
2.5 Participants and eligibility criteria Participants will be recruited from inpatient hospital wards across the participating study centres. The study targets hospitalized older adults with chronic conditions receiving inpatient geriatric, rehabilitation, or neurological care. Eligibility will be determined through screening against predefined inclusion and exclusion criteria in consultation with the treating clinical team.
Inclusion criteria
Participants will be eligible for inclusion if they meet all of the following 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 Potential participants will be screened in consultation with their treating physician to ensure that participation is clinically appropriate and does not interfere with standard medical care.
Exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
Cognitive impairment, defined as a score below 18 on the Montreal Cognitive Assessment (MoCA) Impaired consciousness or reduced alertness that would prevent meaningful participation A 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 2.6 Recruitment Participants will be recruited from inpatient wards of the participating clinical centres. Potential participants will be identified through collaboration with treating physicians, nurses, psychologists, and other members of the clinical care team. Clinical staff will conduct an initial screening based on the study eligibility criteria and will inform potentially eligible patients about the study.
In addition to clinician referral, passive recruitment strategies, including study information leaflets and posters displayed within participating wards, may be used to increase awareness of the study. Family members and caregivers may receive information about the study upon request.
Individuals identified as potentially eligible will receive both verbal and written information regarding the study objectives, procedures, potential benefits, and risks. Adequate time will be provided for consideration and questions before participation is requested. Written informed consent will be obtained by trained study personnel who are not directly involved in the participant's routine clinical care. Enrolment will occur only after written informed consent has been obtained.
After written informed consent has been obtained, participants will undergo study-specific eligibility assessments, including cognitive screening with the Montreal Cognitive Assessment (MoCA). Participants who meet all eligibility criteria will then proceed to baseline assessment before randomization.
Participation in the study is entirely voluntary. Declining participation or withdrawing from the study at any time will not affect the participant's medical care, treatment, or relationship with the healthcare institution. To ensure consistency across study sites, all participating centres will follow a standardized recruitment and informed consent procedure.
Participants who consent to study participation may additionally provide separate consent for follow-up contact after hospital discharge, including telephone-based follow-up assessments when in-person assessment is not feasible.
2.7 Training of study personnel All study personnel involved in participant recruitment, intervention delivery, outcome assessment, and data management will receive standardized study-specific training before the start of participant enrolment.
Personnel responsible for intervention delivery will be trained in the operation of the Zenctuary VR+ system, participant onboarding procedures, use of the operator interface, safety monitoring, and adverse event management. Training will include both theoretical instruction and supervised practical sessions to ensure consistent intervention delivery across study sites. Operators will be instructed to provide assistance according to a standardized least-assistance approach: assistance will be offered only when required for safety, accessibility, technical reasons, or task comprehension, while minimizing unnecessary interference with participant interactions. When assistance is needed, operators will follow a graded sequence beginning with brief verbal prompts or clarification, followed by reassurance or task-specific guidance if required. Direct operator-supported navigation or interaction will be used only when lower levels of assistance are insufficient or when necessary for safety. All operator assistance, session interruptions, early terminations, and relevant participant reactions will be documented in the session log.
Outcome assessors will receive separate training on study procedures, questionnaire administration, and data collection protocols. To maintain assessor blinding, outcome assessors will not participate in intervention delivery and will not have access to participants' treatment allocation.
Training will also cover procedures for documenting protocol deviations, session interruptions, missed sessions, adverse events, implementation challenges, and participant withdrawals. Intervention fidelity will be supported through standardized onboarding materials, operator instructions, session logs, and regular coordination meetings across participating sites.
A standardized study manual and operating procedures will be provided to all participating centres. Prior to participant enrolment, all study personnel will be required to demonstrate competency in their assigned study procedures. Regular meetings will be conducted throughout the study period to review protocol adherence, address procedural issues, and ensure consistency across sites. Any protocol deviations, adverse events, or implementation challenges will be documented and reviewed by the study coordination team.
2.8 Randomization and allocation concealment Participants will be randomly assigned in a 1:1 ratio to either the active VR intervention group or the passive VR control group. A computer-generated block randomization sequence will be prepared by an independent researcher who is not involved in participant recruitment, intervention delivery, outcome assessment, or data analysis.
The randomization sequence will use concealed variable block sizes and will be stratified by study site to support balance across participating centres. The final randomization list will be prepared before the start of recruitment and will be stored in a secure location inaccessible to personnel involved in recruitment, eligibility assessment, informed consent, baseline data collection, outcome assessment, or data analysis.
Allocation concealment will be maintained through centralized computer-generated randomization performed only after participant enrolment and completion of baseline assessment. The randomization sequence will be inaccessible to personnel involved in participant recruitment, eligibility assessment, informed consent procedures, and baseline data collection.
Participants will be enrolled by trained study personnel. Randomization will be initiated only after eligibility has been confirmed, written informed consent has been obtained, and baseline assessment has been completed. The participant will then be assigned to one of the two study groups according to the pre-generated randomization sequence.
Group allocation will be communicated only to the personnel responsible for intervention scheduling and delivery. Outcome assessors will remain blinded to treatment allocation throughout the assessment period.
2.9 Blinding Due to the nature of the intervention, participants and intervention operators cannot be blinded to treatment allocation. However, outcome assessments will be conducted by trained assessors who are not involved in intervention delivery and remain unaware of participants' group assignment. Role separation between intervention operators and outcome assessors will be implemented at each participating site. Whenever possible, outcome assessments will be performed by personnel who do not deliver VR sessions. If staffing constraints at a site limit full personnel separation, the same staff member will not both deliver the intervention and conduct outcome assessments for the same participant.
Assessment scheduling and documentation procedures will be used to preserve assessor blinding throughout the trial. Participants will be instructed not to disclose their allocation during assessment procedures. Any accidental disclosure of group allocation to an outcome assessor will be documented as a protocol deviation. As participants and intervention operators are not blinded, emergency unblinding procedures are not applicable. If feasible, the primary statistical analysis will be conducted using coded group labels.
2.10 Measurements and assessments Outcome assessments will be conducted at three predefined time points: baseline (T0), immediately following completion of the intervention period (T1), and four weeks after the end of the intervention (T2). After written informed consent and before baseline assessment, cognitive screening will be performed using the Montreal Cognitive Assessment (MoCA) as a study-specific eligibility assessment.
To minimize assessment burden in this hospitalized older adult population, questionnaire administration may be divided across two separate assessment sessions when required. In such cases, the interval between sessions will not exceed 48 hours.
At baseline (T0), participants will complete the Hospital Anxiety and Depression Scale (HADS), Rosenberg Self-Esteem Scale (RSES), Generalized Self-Efficacy Scale (GSES), Geriatric Depression Scale (GDS), Beck Hopelessness Scale (BHS), and the Learned Helplessness Scale (LHS). Post-intervention assessments (T1) will include the HADS, RSES, GSES, GDS, and LHS. Follow-up assessments (T2) will include the HADS, RSES, and GSES.
Whenever possible, follow-up assessments will be conducted in person. If a participant has been discharged before the follow-up assessment, data collection may be completed through a structured telephone interview, provided that separate consent for follow-up contact has been obtained.
2.11 Primary outcome The primary outcome of the study is psychological distress, measured using the Hospital Anxiety and Depression Scale (HADS). The HADS is a widely used self-report instrument designed to assess symptoms of anxiety and depression in medical populations. It consists of 14 items divided into two subscales measuring anxiety (HADS-A) and depression (HADS-D). The HADS total score was selected as the primary outcome because the intervention is intended to reduce overall psychological distress rather than anxiety or depressive symptoms alone. The HADS-A and HADS-D subscales will be examined separately as exploratory outcomes to describe whether any intervention-related change is more pronounced in anxiety-related or depression-related symptoms.
The primary efficacy analysis will evaluate changes in HADS total score over time and compare these changes between the active VR intervention group and the passive VR control group. Assessments will be conducted at baseline (T0), immediately following completion of the intervention period (T1), and at four-week follow-up (T2).
The primary hypothesis is that participants receiving the active Zenctuary VR+ intervention will demonstrate a greater reduction in psychological distress compared with participants allocated to the passive VR control condition.
2.12 Secondary outcomes Secondary outcomes will assess psychological constructs that are theoretically related to learned helplessness, perceived control, and adaptation to hospitalization. These measures will be used to explore potential mechanisms through which the intervention may influence psychological distress and well-being.
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES). General self-efficacy will be measured using the General Self-Efficacy Scale (GSES). Hopelessness will be assessed using the Beck Hopelessness Scale (BHS). Depressive symptoms will be measured using the Geriatric Depression Scale (GDS), which is included as a secondary, geriatric-specific measure of depressive symptomatology. Whereas the HADS total score serves as the primary measure of overall psychological distress, the GDS will provide additional information on depressive symptoms in this older inpatient population.
Learned helplessness-related constructs will be assessed using the Learned Helplessness Scale (LHS). Because no fully validated Hungarian version of the LHS is currently available, LHS scores in the present trial will be interpreted as exploratory. The cultural adaptation and psychometric evaluation of the Hungarian version of the LHS will be conducted and reported separately from the primary randomized controlled trial outcomes. The present protocol therefore treats the LHS as an exploratory mechanism-related measure rather than as a primary efficacy endpoint.
Secondary outcome measures will be collected at baseline (T0) and post-intervention (T1). Selected measures, including self-esteem and self-efficacy, will also be collected at follow-up (T2) to explore the persistence of intervention-related effects.
In addition to quantitative outcome measures, qualitative data will be collected through brief semi-structured discussions conducted after each VR session. The resulting data will be analyzed using thematic analysis to explore participants' experiences, perceived benefits, barriers to engagement, and intervention acceptability.
2.13 Sample size [Sample size and power calculation to be detailed here, consistent with the planned enrolment of 100 participants (n = 50 per group) specified in the regulatory approval and trial registration.] 2.14 Statistical analysis The primary analysis will use a linear mixed model to examine group-by-time effects on the HADS total score, following the intention-to-treat principle. Secondary and mechanism-related analyses (RSES, GSES, GDS, BHS, LHS) will be considered exploratory and will be interpreted with appropriate caution given the absence of correction for multiplicity. Qualitative data from post-session discussions will be analyzed using thematic analysis.
[Further detail on the statistical analysis plan, handling of missing data, planned sensitivity analyses, and interim analyses to be specified here.] 2.15 Data management [Data management procedures, including data storage, access control, monitoring, and confidentiality safeguards in accordance with applicable data protection regulation, to be detailed here.] 2.16 Safety, adverse events, and discontinuation Operators will monitor participants throughout each VR session for signs of discomfort, cybersickness, disorientation, or distress, and will follow the graded assistance and safety procedures described in Section 2.7. All operator assistance, session interruptions, early terminations, and relevant participant reactions will be documented in the session log.
[Further detail on adverse event definitions, reporting procedures and timelines, and criteria for participant discontinuation or trial suspension to be specified here.] 2.17 Ethics and dissemination The study has received national ethical and regulatory approval in Hungary from the National Centre for Public Health and Pharmacy (NNGYK; decision no. NNGYK/27626-8/2026, research registry no. 1175), following a favourable scientific and ethical opinion from the Scientific and Research Ethics Committee of the Medical Research Council (ETT TUKEB). Written informed consent will be obtained from all participants prior to enrolment, as described in Section 2.6. ClinicalTrials.gov registration is currently in progress.
Results will be disseminated through peer-reviewed publications, conference presentations, and project-related dissemination activities under the HU-RIZONT International Excellence Research Collaboration Program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Passive VR Control | Sham 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive nature-based virtual reality intervention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psychological Distress (Hospital Anxiety and Depression Scale total score) | 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. | Baseline (T0), immediately post-intervention (T1, after 3 weeks), and 4-week follow-up (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Esteem (Rosenberg Self-Esteem Scale) | Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES), a 10-item self-report measure of global self-worth. | Baseline (T0), immediately post-intervention (T1), and 4-week follow-up (T2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pál Tamás Szabó, postdoctoral researcher | Contact | +36301292315 | szabo.pal@mome.hu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
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| Center for Geriatric Care and Nursing Science (Semmelweis University | Budapest | 1097 | Hungary |
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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| Passive nature-based virtual reality exposure | Device | 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. |
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| Rehabilitációs Klinika | Budapest | 1121 | Hungary |
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| SZTE Department of Neurosurgery | Szeged | 6725 | Hungary |
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