An interventional study of Immersive virtual reality nature exposure and Guided imagery in Anxiety, Hospitalization and Quality of Life, sponsored by Semmelweis University. Recruiting at 2 sites in Hungary. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Semmelweis University · Not applicable, Interventional, and Supportive care
Long hospital stays can be difficult for older adults. Being confined to a ward, with limited mobility and little access to the outdoors, may contribute to anxiety, low mood, and reduced well-being. Contact with nature is known to support relaxation and emotional recovery, but hospitalized patients often cannot go outside.
This study compares two ways of bringing a nature experience to patients who are staying in hospital. In the first approach, participants wear a virtual reality headset and watch 360-degree videos filmed in real natural settings near Budapest: a meadow, a stream, and a mountain. The nature scene reaches them through their eyes and ears. In the second approach, participants listen to a short recorded audio guide and picture the same three nature scenes in their own minds, with their eyes closed. Here the nature scene is created by their own imagination.
Both approaches use exactly the same nature themes. The only difference is how the experience reaches the person: from the outside through the senses, or from the inside through imagination. The study asks whether these two routes have different effects, and whether they can be told apart by measuring heart rate variability, which reflects how the body's automatic nervous system responds.
Participants are adults aged 65 or older who have been in hospital for at least two weeks. After joining the study, each participant is first observed for two weeks while receiving only their usual hospital care. This period serves as their own comparison. They are then assigned by chance to one of the two approaches and take part in three sessions over two weeks. Questionnaires and brief cognitive tests are completed at three points: when joining, before the sessions begin, and after the sessions end.
The main question is whether anxiety symptoms decrease more during the session period than during the preceding period of usual care. The study also looks at mood, attention and memory, well-being, and resilience.
This is a prospective, two-arm, parallel-group randomized controlled trial conducted at two clinical sites of Semmelweis University: the Department of Geriatrics and Nursing Science, and the Department of Rehabilitation Medicine.
A distinctive feature of the design is that all participants undergo an observation period of equal length under treatment as usual before randomization, so that each participant serves as their own control for the pre-intervention period. This allows the change observed during the intervention period to be distinguished from time-dependent processes occurring during hospitalization itself. This design was chosen because neither a waiting-list control nor a no-treatment condition was considered ethically acceptable in this population.
Participants are enrolled after approximately two weeks of hospitalization (T0). A two-week observation period under usual care follows, during which a single resting heart rate variability recording is obtained. The T1 assessment is conducted at the end of this period, followed by randomization and three intervention sessions delivered over two weeks. The T2 assessment follows the intervention period. No follow-up assessment is conducted.
The two arms differ only in the processing route. The virtual reality arm delivers the natural environment as bottom-up perceptual input via a head-mounted display, using proprietary 360-degree videos recorded from a fixed tripod perspective at three locations near Budapest. The videos contain no narration or added music, only the natural soundscape of the location. The guided imagery arm delivers the same content as an internally generated, top-down process, using a standardized audio recording that begins with a brief breathing relaxation followed by the motif text. Both arms use identical standardized symbolic nature motifs (meadow, stream, mountain) drawn from the motif repertoire of Katathym Imaginative Psychotherapy. The design therefore does not compare an active intervention with a passive control, but two content-equivalent interventions that differ in their processing pathway.
Two primary outcomes are specified. The primary clinical outcome is the change in anxiety symptoms between T1 and T2. The primary mechanistic outcome is RMSSD recorded during the intervention sessions, computed from a five-minute artifact-free window in both arms. Heart rate variability is recorded in three contexts: once at rest during the observation period, during each intervention session, and during neuropsychological testing at each assessment point.
Because hospitalized older adults frequently present with multimorbidity and complex medication regimens, clinical background variables that may affect autonomic regulation and cognitive performance are systematically recorded, including pacemaker status, sympatholytic and psychotropic medication, endocrine conditions, and clinically relevant laboratory abnormalities.
The protocol was prepared in accordance with the SPIRIT 2025 Statement. Registration was performed retrospectively, after enrollment of the first participant. The trial design, including all primary and secondary outcome measures and the statistical analysis plan, was finalized and approved by the research ethics committee before enrollment began, and registration preceded any analysis of outcome data.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Enrolment is deferred, rather than excluded, in the presence of active delirium or infectious illness, until the condition resolves.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants view 360-degree nature videos through a head-mounted display in a seated or semi-seated position. The videos were produced by the research team from a fixed tripod perspective at three locations near Budapest, corresponding to the three standardized motifs (meadow, stream, mountain). They contain no narration or added music, only the natural soundscape of the location. The viewpoint changes every five minutes. Exposure length ranges from 8 to 20 minutes according to participant tolerance. Three sessions are delivered over two weeks.
Device: Immersive virtual reality nature exposure
Participants listen through headphones, in a seated or semi-seated position with eyes closed, to a standardized five-minute audio recording that begins with a brief breathing relaxation followed by the motif text. The motifs are identical to those presented in the virtual reality arm (meadow, stream, mountain). After the session, participants give a free verbal account of their experience. Three sessions are delivered over two weeks.
Behavioral: Guided imagery
Three sessions of 360-degree nature video viewed through a head-mounted display, delivered over two weeks. Videos were produced by the research team from a fixed tripod perspective at three locations near Budapest, corresponding to the motifs of meadow, stream, and mountain. They contain no narration or added music, only the natural soundscape of the location, and the viewpoint changes every five minutes. Exposure length ranges from 8 to 20 minutes according to participant tolerance. Sessions are conducted at the bedside under supervision, with the device used offline.
Three sessions of guided imagery delivered over two weeks. Participants listen through headphones, with eyes closed, to a standardized five-minute audio recording that begins with a brief breathing relaxation followed by the motif text. The motifs are identical to those presented in the virtual reality arm and are drawn from the motif repertoire of Katathym Imaginative Psychotherapy. After each session, participants give a free verbal account of their experience.
Heart rate variability during intervention sessions relative to resting and cognitive-load recordings (RMSSD)
Root mean square of successive differences (RMSSD, ln-transformed) recorded during intervention sessions and compared within each participant with their own resting recording (20-minute recording during the usual care period, five-minute window analysed) and cognitive-load recordings (T0 and T1). RMSSD is computed from a five-minute artifact-free window in all contexts; higher values indicate greater parasympathetic activity. Recordings with more than 5 percent corrected beats are excluded from the primary analysis. Recordings are made with an optical photoplethysmographic armband sensor; the first five participants were recorded with a chest-strap ECG sensor in all contexts. The between-arm comparison of session RMSSD is a secondary, exploratory analysis.
Time frame: Baseline through Week 4 (resting recording during the usual care period; cognitive load at baseline and Week 2; intervention sessions from Week 2 through Week 4)
Primary Outcome 1 - HADS-A
Anxiety symptoms measured with the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Scores range from 0 to 21; lower scores indicate less anxiety. The primary comparison is the change during the intervention period (T1 to T2) relative to the change during the preceding usual care observation period (T0 to T1), with each participant serving as their own control (self-controlled, non-randomised contrast, both arms pooled). The randomised between-arm comparison of T2 scores adjusted for T1 scores is a secondary analysis. Analyses use linear mixed models.
Time frame: Baseline, Week 2, and Week 4.
Change in depressive symptoms (HADS-D)
Depressive symptoms measured with the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Scores range from 0 to 21; lower scores indicate fewer depressive symptoms.
Time frame: Baseline, Week 2, and Week 4
Change in depressive symptoms (GDS-15)
Depressive symptoms measured with the 15-item Geriatric Depression Scale (GDS-15). Scores range from 0 to 15; higher scores indicate more depressive symptoms.
Time frame: Baseline, Week 2, and Week 4
Change in global cognitive performance (MoCA)
Global cognitive performance measured with the Montreal Cognitive Assessment, Hungarian version. Scores range from 0 to 30 with education correction; higher scores indicate better cognitive performance. Three parallel versions (8.1, 8.2, 8.3) are administered in fixed order across the three assessment points to reduce practice effects.
Time frame: Baseline, Week 2, and Week 4
Change in memory index (MoCA-MIS)
Memory Index Score derived from the delayed recall section of the Montreal Cognitive Assessment, weighting free recall, category-cued recall, and multiple-choice recall. Scores range from 0 to 15; higher scores indicate better memory performance.
Time frame: Baseline, Week 2, and Week 4
Change in attentional performance (MoCA attention subscale)
Attention subscale derived from the Montreal Cognitive Assessment, comprising forward and backward digit span, the vigilance task, and serial sevens subtraction. Scores range from 0 to 6; higher scores indicate better attentional performance. This subscale is analysed separately because both interventions are hypothesised to act through attentional processes, which the total score does not capture.
Time frame: Baseline, Week 2, and Week 4
Change in processing speed (Trail Making Test A)
Processing speed and visual search measured with Part A of the Trail Making Test. The outcome is completion time in seconds; shorter times indicate better performance.
Time frame: Baseline, Week 2, and Week 4
Change in quality of life (CASP-19)
Quality of life measured with the CASP-19 questionnaire, reported as total score and as four subscale scores covering control, autonomy, self-realisation, and pleasure. Higher scores indicate better quality of life. The control and autonomy subscales are of particular interest given the loss of control associated with hospitalisation.
Time frame: Baseline and Week 4
Change in resilience (CD-RISC-10)
Resilience measured with the 10-item Connor-Davidson Resilience Scale. Scores range from 0 to 40; higher scores indicate greater resilience.The baseline score is additionally examined as a potential moderator of change in anxiety.
Time frame: Baseline and Week 4
Change in heart rate variability during cognitive testing (RMSSD)
Root mean square of successive differences (RMSSD) recorded during neuropsychological testing, expressed in milliseconds; higher values indicate greater parasympathetic activity. The Montreal Cognitive Assessment and Trail Making Test Part A are treated as a single continuous cognitive load block, and RMSSD is computed from a five-minute artifact-free window starting at the beginning of the block. This measure reflects the autonomic response to a standardised external stressor, complementing the recording obtained during the intervention sessions.
Time frame: Baseline, Week 2, and Week 4
Affective state before intervention sessions (Emotion Thermometers)
Affective state assessed with the Emotion Thermometers, comprising five visual analogue dimensions (distress, anxiety, depression, anger, and need for help). Each dimension is rated from 0 to 10; higher scores indicate greater distress. The instrument is administered at each assessment point (baseline, Week 2, Week 4) and immediately before each intervention session. It is not administered after the sessions, in order to minimise participant burden and to preserve the period immediately following the session, during which participants in the guided imagery arm give their verbal account. The measure characterises the affective state at the start of each assessment and session day and its trajectory across the four weeks of participation, rather than acute within-session change.
Time frame: Baseline, Week 2, Week 2 through Week 4, and Week 4
Immersive tendency (ITQ-10)
Dispositional tendency to become involved and absorbed in an experience, measured with the 10-item Hungarian version of the Immersive Tendencies Questionnaire. Higher scores indicate a greater tendency towards immersion. The questionnaire is administered once, before randomisation, in both arms, and is treated as a trait-level moderator variable rather than a mediator. Only the total score is used; the subscales are not analysed separately because two items of the attention focus subscale refer to current alertness and physical condition, which in hospitalised older adults primarily reflect current illness burden.
Time frame: Baseline
Virtual reality sickness symptoms (VRSQ)
Symptoms associated with virtual reality use, measured with the Virtual Reality Sickness Questionnaire, comprising nine items grouped into an oculomotor and a disorientation component; higher scores indicate more severe symptoms. The questionnaire is administered in the virtual reality arm only, after the first session. It is used to monitor tolerability rather than as an efficacy outcome. Tolerability in both arms is additionally monitored at every session through structured recording of adverse events by the facilitator.
Time frame: Week 2
Plan to share: No — Individual participant data will not be shared publicly. The dataset contains detailed clinical, medication, and laboratory information collected from a small sample of hospitalised older adults at two clinical departments, and the combination of these variables would create a re-identification risk that pseudonymisation alone cannot adequately address. Aggregated and anonymised results will be reported in peer-reviewed publications. Requests for access to specific data supporting the published findings may be directed to the corresponding author and will be considered on a case-by-case basis, subject to institutional and ethical approval.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jan 2027, 19 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 19 months is close to that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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