Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Virtual Nature Versus Guided Imagery for Anxiety and Well-Being in Hospitalized Older Adults

10. august 2026 opdateret af: Semmelweis University

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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
60

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Ungarn
      • Budapest, Ungarn, 1097
        • Rekruttering
        • Semmelweis University, Department of Geriatrics and Nursing Science
        • Kontakt:
        • Kontakt:
      • Budapest, Ungarn, 1121
        • Rekruttering
        • Semmelweis University, Department of Rehabilitation Medicine
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Beata Reka Vasarhelyi, MA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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.
Enhed: Immersive virtual reality nature exposure
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.
Aktiv 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.
Adfærdsmæssigt: Guided imagery
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.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in anxiety symptoms (HADS-A)
Tidsramme: Baseline, Week 2, and Week 4
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)
Tidsramme: Week 2 through Week 4
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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in depressive symptoms (HADS-D)
Tidsramme: Baseline, Week 2, and Week 4
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.
Baseline, Week 2, and Week 4
Change in depressive symptoms (GDS-15)
Tidsramme: Baseline, Week 2, and Week 4
Depressive symptoms measured with the 15-item Geriatric Depression Scale (GDS-15). Scores range from 0 to 15; higher scores indicate more depressive symptoms.
Baseline, Week 2, and Week 4
Change in global cognitive performance (MoCA)
Tidsramme: Baseline, Week 2, and Week 4
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.
Baseline, Week 2, and Week 4
Change in memory index (MoCA-MIS)
Tidsramme: Baseline, Week 2, and Week 4
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.
Baseline, Week 2, and Week 4
Change in attentional performance (MoCA attention subscale)
Tidsramme: Baseline, Week 2, and Week 4
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.
Baseline, Week 2, and Week 4
Change in processing speed (Trail Making Test A)
Tidsramme: Baseline, Week 2, and Week 4
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.
Baseline, Week 2, and Week 4
Change in quality of life (CASP-19)
Tidsramme: Baseline and Week 4
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.
Baseline and Week 4
Change in resilience (CD-RISC-10)
Tidsramme: Baseline and Week 4
Resilience measured with the 10-item Connor-Davidson Resilience Scale. Scores range from 0 to 40; higher scores indicate greater resilience.
Baseline and Week 4
Change in heart rate variability during cognitive testing (RMSSD)
Tidsramme: Baseline, Week 2, and Week 4
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.
Baseline, Week 2, and Week 4

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Affective state before intervention sessions (Emotion Thermometers)
Tidsramme: Week 2 through Week 4
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.
Week 2 through Week 4
Immersive tendency (ITQ-10)
Tidsramme: Baseline
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.
Baseline
Virtual reality sickness symptoms (VRSQ)
Tidsramme: Week 2
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.
Week 2

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Semmelweis University

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Xenia Gonda, MA, PharmD, PhD, Semmelweis University, Department of Psychiatry and Psychotherapy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. juni 2025

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. januar 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. januar 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
4. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
10. august 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
14. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
14. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
10. august 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • SE-VRGI-2025
  • BM/28270-1/2024 (Anden identifikator: Scientific and Research Ethics Committee of the Medical Research Council (ETT TUKEB), Hungary)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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