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.
