- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07580352
Assessing the Feasibility of Using Virtual Reality Experiences in Older Adults
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Background and Significance
Seriously ill older adults frequently harbor unfulfilled end-of-life aspirations, commonly referred to as "bucket list" experiences. Advanced illness, functional decline, and the constraints of institutional living typically render travel and other real world experiences largely unattainable for this population. Virtual reality (VR) technology, now widely commercially available, may offer an accessible means of delivering immersive surrogate experiences at the bedside. However, the feasibility of VR engagement among seriously ill nursing home residents - including their capacity to tolerate head-mounted display use, sustain attention during immersion, and derive meaningful benefit - has not been adequately established. The present study seeks to address this gap.
Specific Aims:
- To determine the feasibility of administering immersive VR experiences to seriously ill older adult nursing home residents using a commercially available head-mounted display.
- To compare participant ability to tolerate two distinct VR delivery modalities: computer-generated virtual reality (CG-VR) and film-based virtual reality (FB-VR).
- To explore, through qualitative inquiry, participant perceptions of VR as a vehicle for fulfilling personally meaningful experiences (virtual bucket-listing).
Study Design
This is a feasibility study employing a randomized, two-arm parallel-group design with an optional crossover component and embedded qualitative interviews.
Study Population: Seriously ill older adult residents of the participating nursing home facility.
Study Procedures
Following written informed consent, each participant will be invited to articulate a personal bucket list. Participants who identify one or more bucket list items will be randomly assigned in a 1:1 ratio to one of two arms:
- Arm A: A three-minute immersive waterfall experience delivered via CG-VR.
- Arm B: A three-minute immersive waterfall experience delivered via FB-VR. All VR content will be delivered using the Meta Quest Pro head-mounted display. Following the initial experience, participants will be offered the option to engage in a second VR session - either the alternate modality (CG-VR or FB-VR) or an alternative VR environment of personal significance to the participant.
Outcome Measures:
Primary outcomes (feasibility): Consent, completion of the assigned VR experience, and adverse events (including cybersickness, agitation, or discomfort).
Secondary outcomes:
- Change in symptom burden as measured by pre- and post-experience scores on the Edmonton Symptom Assessment System-Revised (ESAS-r).
- Participant-reported relaxation ratings obtained immediately following the VR experience.
- Qualitative data derived from post-experience semi-structured interviews for thematic analysis.
Risks and Anticipated Benefits:
Risks are anticipated to be minimal and primarily limited to transient cybersickness, mild disorientation, or emotional response to the experiential content. Participants may benefit from symptom relief, relaxation, and engagement with personally meaningful imagery, although direct benefit is not assured. Findings will inform the design of subsequent efficacy trials evaluating VR as a palliative intervention.
Statistical Considerations:
Given that this is a feasibility pilot study, there is no hypothesis testing and the study is not powered to detect efficacy.Descriptive statistics will be employed to characterize feasibility metrics and outcome distributions.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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California
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Palo Alto, California, Stany Zjednoczone, 94304
- Stanford University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria: Seriously ill nursing home residents identified by their care team as able to participate.
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Exclusion Criteria: <65 years of age
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Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Computer-generated VR waterfalls
This is a computer-generated VR waterfalls
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Commercially available Meta Quest Pro was used to show a waterfalls virtually to the participants in one of two renderings-- computer generated waterfalls or a film-based waterfalls.
Both types of renderings are viewed by the exact same equipment and headset.
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Aktywny komparator: Film-based VR waterfalls
This is a film-based VR waterfalls
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Commercially available Meta Quest Pro was used to show a waterfalls virtually to the participants in one of two renderings-- computer generated waterfalls or a film-based waterfalls.
Both types of renderings are viewed by the exact same equipment and headset.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Edmonton Symptom Assessment Scale (ESASr)
Ramy czasowe: Baseline
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ESAS-r assessed nine common symptoms (Pain, Fatigue, Nausea, Depression, Anxiety, Drowsiness, Shortness of Breath, Appetite, and Wellbeing) on 0-10 scales.
(cite) A sleep item was also included.
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Baseline
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Relaxation scale
Ramy czasowe: Immediately before and after the 3-minute VR exposure.
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Relaxation was assessed with a single item (0 = not relaxed at all; 10 = extremely relaxed)
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Immediately before and after the 3-minute VR exposure.
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
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
Inne numery identyfikacyjne badania
- 67522
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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