Virtual Nature Versus Guided Imagery for Anxiety and Well-Being in Hospitalized Older Adults
Bottom-Up Virtual Nature Versus Top-Down Guided Imagery in Hospitalized Older Adults: A Randomized Parallel-Group Clinical Trial
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Patricia Lajko, MA
- Numer telefonu: +36309874988
- E-mail: lajko.patricia@semmelweis.hu
Kopia zapasowa kontaktu do badania
- Nazwa: Xenia Gonda, MA, PharmD, PhD
- Numer telefonu: +36 1 235 6500
- E-mail: gonda.xenia@semmelweis.hu
Lokalizacje studiów
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Budapest, Węgry, 1097
- Rekrutacyjny
- Semmelweis University, Department of Geriatrics and Nursing Science
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Kontakt:
- Patricia Lajko, MA
- Numer telefonu: +36309874988
- E-mail: lajko.patricia@semmelweis.hu
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Kontakt:
- Xenia Gonda, MA, PharmD, PhD
- Numer telefonu: +36 1 235 6500
- E-mail: gonda.xenia@semmelweis.hu
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Budapest, Węgry, 1121
- Rekrutacyjny
- Semmelweis University, Department of Rehabilitation Medicine
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Kontakt:
- Patricia Lajko
- Numer telefonu: +3606309874988
- E-mail: lajko.patricia@semmelweis.hu
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Kontakt:
- Xenia Gonda, MA, PharmD, PhD
- Numer telefonu: +36 1 235 6500 06309874988
- E-mail: gonda.xenia@semmelweis.hu
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Główny śledczy:
- Beata Reka Vasarhelyi, MA
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Aged 65 years or older
- Receiving inpatient hospital care, with at least two weeks of hospitalisation at the time of enrolment
- Montreal Cognitive Assessment (Hungarian version) score of 18 or above, with education correction
- Physically able to safely wear a head-mounted virtual reality display
- Adequate corrected or uncorrected vision and hearing
- Able to communicate in Hungarian
- Stable psychiatric and cardiovascular condition, as determined from medical history and in consultation with the treating physician
- Able to provide independent written informed consent
Exclusion Criteria:
- Epilepsy with recurrent seizures, or photosensitivity
- Neurological condition associated with increased risk during virtual reality use, including Meniere's disease and significant carotid stenosis
- Active psychosis, hallucinations, or severe depression with psychotic features
- Open wound or skin lesion on the face, chronic neck pain, or spinal condition preventing safe use of the head-mounted display
- Severe uncorrectable sensory impairment
- Unstable psychotropic medication during the preceding eight weeks
- Regular use of analgesic or psychotropic medication that may substantially affect perception of the experience
- Active alcohol or substance use disorder within the past year
- Refusal or inability to provide informed consent
Enrolment is deferred, rather than excluded, in the presence of active delirium or infectious illness, until the condition resolves.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Immersive virtual reality nature exposure
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.
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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.
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Aktywny komparator: Guided imagery
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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in anxiety symptoms (HADS-A)
Ramy czasowe: Baseline, Week 2, and Week 4
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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.
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Baseline, Week 2, and Week 4
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Heart rate variability during intervention sessions (RMSSD)
Ramy czasowe: Week 2 through Week 4
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Root mean square of successive differences (RMSSD) recorded during intervention sessions with an optical photoplethysmographic armband sensor and analysed with dedicated heart rate variability software.
RMSSD is computed from a five-minute artifact-free window in both arms and expressed in milliseconds; higher values indicate greater parasympathetic activity.
Recordings with more than 5 percent corrected beats are excluded.
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Week 2 through Week 4
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in depressive symptoms (HADS-D)
Ramy czasowe: Baseline, Week 2, and Week 4
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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.
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Baseline, Week 2, and Week 4
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Change in depressive symptoms (GDS-15)
Ramy czasowe: Baseline, Week 2, and Week 4
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Depressive symptoms measured with the 15-item Geriatric Depression Scale (GDS-15).
Scores range from 0 to 15; higher scores indicate more depressive symptoms.
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Baseline, Week 2, and Week 4
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Change in global cognitive performance (MoCA)
Ramy czasowe: Baseline, Week 2, and Week 4
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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.
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Baseline, Week 2, and Week 4
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Change in memory index (MoCA-MIS)
Ramy czasowe: Baseline, Week 2, and Week 4
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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.
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Baseline, Week 2, and Week 4
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Change in attentional performance (MoCA attention subscale)
Ramy czasowe: Baseline, Week 2, and Week 4
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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.
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Baseline, Week 2, and Week 4
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Change in processing speed (Trail Making Test A)
Ramy czasowe: Baseline, Week 2, and Week 4
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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.
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Baseline, Week 2, and Week 4
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Change in quality of life (CASP-19)
Ramy czasowe: Baseline and Week 4
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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.
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Baseline and Week 4
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Change in resilience (CD-RISC-10)
Ramy czasowe: Baseline and Week 4
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Resilience measured with the 10-item Connor-Davidson Resilience Scale.
Scores range from 0 to 40; higher scores indicate greater resilience.
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Baseline and Week 4
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Change in heart rate variability during cognitive testing (RMSSD)
Ramy czasowe: Baseline, Week 2, and Week 4
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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.
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Baseline, Week 2, and Week 4
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Affective state before intervention sessions (Emotion Thermometers)
Ramy czasowe: Week 2 through Week 4
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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 immediately before each intervention session and is not repeated afterwards, 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 therefore characterises the baseline affective state of each session and the trajectory across sessions, rather than acute within-session change.
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Week 2 through Week 4
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Immersive tendency (ITQ-10)
Ramy czasowe: Baseline
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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.
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Baseline
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Virtual reality sickness symptoms (VRSQ)
Ramy czasowe: Week 2
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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.
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Week 2
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Xenia Gonda, MA, PharmD, PhD, Semmelweis University, Department of Psychiatry and Psychotherapy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SE-VRGI-2025
- BM/28270-1/2024 (Inny identyfikator: Scientific and Research Ethics Committee of the Medical Research Council (ETT TUKEB), Hungary)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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