- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07580352
Assessing the Feasibility of Using Virtual Reality Experiences in Older Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Palo Alto, California, Forenede Stater, 94304
- Stanford University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria: Seriously ill nursing home residents identified by their care team as able to participate.
-
Exclusion Criteria: <65 years of age
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Computer-generated VR waterfalls
This is a computer-generated VR waterfalls
|
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.
|
|
Aktiv komparator: Film-based VR waterfalls
This is a film-based VR waterfalls
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Edmonton Symptom Assessment Scale (ESASr)
Tidsramme: Baseline
|
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.
|
Baseline
|
|
Relaxation scale
Tidsramme: Immediately before and after the 3-minute VR exposure.
|
Relaxation was assessed with a single item (0 = not relaxed at all; 10 = extremely relaxed)
|
Immediately before and after the 3-minute VR exposure.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 67522
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med Feasibility of using VR
-
Rigshospitalet, DenmarkRekrutteringAkut myeloid leukæmi (AML)Danmark
-
University of MiamiTrukket tilbage
-
Stanford UniversityIkke rekrutterer endnuAngst | Påvirke | Lempelse | Velvære, psykologiskForenede Stater