NCT07765355

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
4mo left

Started Jun 2025

Typical duration for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jun 2025Jan 2027

Study Start

First participant enrolled

June 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.6 years

First QC Date

August 4, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

virtual realityguided imagerynature exposureheart rate variabilityhospitalized older adultstop-down processingbottom-up processingRMSSDgeriatricsKatathym Imaginative Psychotherapysymbol therapy

Outcome Measures

Primary Outcomes (2)

  • Change in anxiety symptoms (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.

    Baseline, Week 2, and Week 4

  • Heart rate variability during intervention sessions (RMSSD)

    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.

    Week 2 through Week 4

Secondary Outcomes (9)

  • Change in depressive symptoms (HADS-D)

    Baseline, Week 2, and Week 4

  • Change in depressive symptoms (GDS-15)

    Baseline, Week 2, and Week 4

  • Change in global cognitive performance (MoCA)

    Baseline, Week 2, and Week 4

  • Change in memory index (MoCA-MIS)

    Baseline, Week 2, and Week 4

  • Change in attentional performance (MoCA attention subscale)

    Baseline, Week 2, and Week 4

  • +4 more secondary outcomes

Other Outcomes (3)

  • Affective state before intervention sessions (Emotion Thermometers)

    Week 2 through Week 4

  • Immersive tendency (ITQ-10)

    Baseline

  • Virtual reality sickness symptoms (VRSQ)

    Week 2

Study Arms (2)

Immersive virtual reality nature exposure

EXPERIMENTAL

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

Guided imagery

ACTIVE COMPARATOR

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

Interventions

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.

Immersive virtual reality nature exposure
Guided imageryBEHAVIORAL

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.

Guided imagery

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Semmelweis University, Department of Geriatrics and Nursing Science

Budapest, 1097, Hungary

RECRUITING

Semmelweis University, Department of Rehabilitation Medicine

Budapest, 1121, Hungary

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Xenia Gonda, MA, PharmD, PhD

    Semmelweis University, Department of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xenia Gonda, MA, PharmD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Neither participants nor facilitators can be masked given the nature of the interventions. Outcome assessments are conducted by ward clinical psychologists who may learn the allocation through routine patient contact; assessor masking is therefore not claimed. Heart rate variability data are processed using predefined automated parameters without knowledge of group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in a 1:1 ratio to one of two intervention arms. Prior to randomization, all participants complete a two-week observation period under treatment as usual, which serves as a within-participant control period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 14, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations