- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07644416
Using Virtual Reality Travel to Reduce Loneliness in Older Adults (VRT)
Virtual Reality Travel (VRT) as a Loneliness Intervention for Older Adults: A Pilot Randomized Controlled Trial
This study aims to investigate whether and how virtual reality travel (VRT) can reduce loneliness among older adults. It will utilize a mixed-methods research design that combines an randomly assigned experiment with follow-up semi-structured interviews.
This is a pilot study and it is essential to establish the feasibility and acceptability of the protocol, assess the tolerability of VR technology in this population prior to conducting a full-scale RCT, and generate preliminary effect size estimates to inform future sample size calculations.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ruiping Ren
- Numero di telefono: 812-671-4087
- Email: renruip@iu.edu
Luoghi di studio
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Indiana
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Bloomington, Indiana, Stati Uniti, 47401
- Evergreen Village at Bloomington
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Contatto:
- Sherri Ganka
- Numero di telefono: 812-336-2718
- Email: resident.services@evergreenvillage-bloomington.com
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Bloomington, Indiana, Stati Uniti, 47408
- Bell Trace
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Contatto:
- Melissa Davis
- Numero di telefono: 812-332-2355
- Email: mdavis@cardon.us
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Ellettsville, Indiana, Stati Uniti, 47429
- Area 10 Agency on Aging
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Contatto:
- Amy Guerrettaz
- Numero di telefono: 812-935-2582
- Email: aguerrettaz@area10agency.org
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults aged 65 years or older
- Express willingness to engage with VR technology
Exclusion Criteria:
- No self-reported physical, sensory, neurological, or cognitive conditions that would make VR use unsafe or impractical (e.g., uncontrolled seizures, severe vertigo, or significant uncorrected vision/hearing impairments).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Virtual reality travel group
Participants in the VR travel group experience a 13-minute-and-44-second VR tour of Bali Island, Indonesia.
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Participants in the VR travel group experience a 13-minute-and-44-second VR tour of Bali Island, Indonesia.
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Comparatore attivo: Attention control group
Participants in the attention control group complete 13-minute-and-44-second symmetric puzzles featuring leaves, birds, and insects.
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Participants in the attention control group complete 13 minutes and 44 seconds symmetric puzzles featuring leaves, birds, and insects.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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loneliness
Lasso di tempo: Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
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Loneliness was assessed using a multi-item visual analog scale (VAS), with items presented as 100 mm horizontal lines anchored by "Not at all" (left) and "Extremely" (right). Items were adapted from the University of California, Los Angeles Loneliness Scale and modified to capture present-moment experience using a "Right now…" stem, enabling assessment of state-level rather than trait-level loneliness. Participants were instructed to indicate their current feelings by placing a single perpendicular mark on each line corresponding to their response. VAS scores were calculated by measuring the distance in millimeters from the left anchor to the participant's mark, yielding a continuous score ranging from 0 to 100 for each item. Item scores were then averaged to compute an overall loneliness score, with higher values indicating higher levels of state loneliness. |
Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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positive emotions
Lasso di tempo: Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
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Positive emotions was assessed using the Positive and Negative Affect Schedule (PANAS).
The PANAS consists of 20 items, including 10 items measuring positive affect (e.g., interested, excited, enthusiastic) and 10 items measuring negative affect (e.g., distressed, upset, nervous).
Participants were asked to indicate the extent to which they were experiencing each emotion right now on a Likert-type scale ranging from 1 (Very slightly or not at all) to 5 (Extremely), consistent with the state version of the measure.
Scores for positive affect and negative affect were computed separately by averaging the corresponding items, with higher scores indicating greater levels of the respective emotional state.
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Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
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meaning in life
Lasso di tempo: Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
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Meaning in life was assessed using a modified version of the Multidimensional Existential Meaning Scale.
To capture state meaning in life, the phrase "right now" was added to each item to reflect participants' momentary perceptions.
The MEMS is a 15-item multidimensional measure based on a tripartite conceptualization of meaning in life encompassing comprehension (life coherence), purpose (goal-directedness), and mattering (perceived significance).
Participants rated each item on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree).
Each subscale consists of five items, and subscale scores were computed by averaging corresponding items, with one mattering item reverse scored.
Higher scores indicate greater levels of comprehension, purpose, and mattering.
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Baseline and following completion of the intervention session (approximately 20-30 minutes after baseline assessment)
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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IUB-VRTPilot-2026
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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