VR-Based Cognitive Stimulation Games for Delirium Prevention
8. juni 2026 oppdatert av: Hina Faisal, The Methodist Hospital Research Institute
Virtual Reality-Based Cognitive Stimulation Games for Enhancing Attention and Preventing Delirium in Older Surgical Patients With Cognitive Impairment
This trial aims to evaluate the feasibility, safety, and acceptability of a virtual reality (VR)-based cognitive stimulation game to reduce postoperative delirium among older surgical patients at high risk due to pre-existing cognitive impairment.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Delirium is a sudden, fluctuating disturbance in consciousness and cognition and is highly prevalent in older surgical patients.
Delirium is preventable; non-pharmacological interventions, such as cognitive stimulation (CS), are the best preventive strategies.
Implementing CS in acute hospital settings is a significant challenge due to limited resources and low patient engagement.
Virtual reality (VR) and gamification for CS delivery could be a scalable, engaging solution.
Based on my preliminary work, I hypothesize that VR- based CS games will be safe, feasible, and acceptable in high-risk older patients (Aim 1).
The proposed study will estimate the intervention's effect on cognitive functions, particularly sustained attention (Aim 2), and the incidence of postoperative delirium (Aim 3).
To accomplish the above goals, I will conduct a randomized controlled pilot trial involving 90 patients ≥65 years old with pre-existing cognitive impairment admitted to the hospital following a major surgery.
Patients will be randomized 1:1:1 to receive VR-based CS games (intervention), watch a VR movie (VR control), or receive standard-of-care nurse-led reality orientation (Nurse control).
The trial will provide me with preliminary data to support an R01 application.
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hina Faisal, MD
- Telefonnummer: 346-356-1400
- E-post: hfaisal@houstonmethodist.org
Studiesteder
-
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Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Houston Methodist Hospital
-
Ta kontakt med:
- Hina Faisal, MD
- Telefonnummer: 713-448-0343
- E-post: hfaisal@houstonmethodist.org
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- Houston Methodist Research Insititute
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Hovedetterforsker:
- Hina Faisal, MD
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Men and women ≥65 years of age
- Have a pre-existing diagnosis of cognitive impairment (Montreal Cognitive Assessment Score of 15-24)
- Elective or emergency major surgery with the expectation of admission to the Intensive Care Unit following the surgery for three days following surgery
Exclusion Criteria:
- Pre-existing Intubation and invasive ventilation;
- history of severe mental illness;
- admission for a drug overdose;
- severe vertigo;
- history of severe postoperative nausea and vomiting;
- hearing and visual impairment;
- preexisting severe dementia (Montreal Cognitive Assessment Score < 15; and
- active delirium at the time of screening for eligibility criteria.
- Active suicidal ideation or behavior Screen failure after surgery
- Prolonged intubation after surgery (more than 24 hours)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: VR intervention: VR-based cognitive stimulation games
Participants will engage in interactive, VR-based cognitive stimulation games.
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The ReCognition virtual reality (VR) software is delivered via an Oculus Quest 2 device.
This three-dimensional simulated software was designed to improve attention and executive functions.
The VR session will occur once per day for 20 minutes.
|
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Eksperimentell: VR Control: watching a movie in VR
Participants will watch a non-interactive VR movie experience consisting of educational material.
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This virtual reality software is delivered via an Oculus Quest 2 device.
The Oculus Quest 2 device will be used to watch an educational movie.
The VR session will occur once per day for 20 minutes.
|
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Eksperimentell: Nurse control: standard-of-care nurse-led reality orientation
Participants will receive standard-of-care, nurse-led reality orientation therapy.
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Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of the trial and VR-based cognitive stimulation intervention
Tidsramme: At Postoperative day 7 or Hospital discharge (whichever comes first)
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A composite of recruitment rate, outcomes data completion, usability of VR intervention, acceptance of the VR intervention, and adherence to VR sessions
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At Postoperative day 7 or Hospital discharge (whichever comes first)
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Adherence of VR-based cognitive stimulation intervention
Tidsramme: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)
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Number screened, consented, enrolled, and administered VR
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Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)
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Safety of VR-based cognitive stimulation intervention
Tidsramme: Postoperative day 1 -3
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adverse event
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Postoperative day 1 -3
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Acceptability of VR-based cognitive stimulation intervention
Tidsramme: At Postoperative day 7 or Hospital discharge (whichever comes first)
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Behavioral intention scale score
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At Postoperative day 7 or Hospital discharge (whichever comes first)
|
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Usability of VR-based cognitive stimulation intervention
Tidsramme: At Postoperative day 7 or Hospital discharge (whichever comes first)
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System usability scale score
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At Postoperative day 7 or Hospital discharge (whichever comes first)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Months backward test, pre-intervention
Tidsramme: At Post operative day 1
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Measurement of attention and working memory (Cognitive outcome)
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At Post operative day 1
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Months backward test, post-intervention
Tidsramme: At Post-operative Day 3
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Measurement of attention and working memory
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At Post-operative Day 3
|
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NIH Flanker test, pre-intervention
Tidsramme: At Post operative day 1
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Measurement of attention and working memory (Cognitive outcome)
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At Post operative day 1
|
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NIH Flanker test, post-intervention
Tidsramme: At Post operative day 3
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Measurement of attention and working memory (Cognitive outcome)
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At Post operative day 3
|
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VR games performances
Tidsramme: At Postoperative day 1, 2 and 3
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Measurement of attention and working memory (Cognitive outcome)
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At Postoperative day 1, 2 and 3
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect size of VR cognitive simulation games on postoperative delirium (Exploratory outcome)
Tidsramme: Postoperative day 7 or Hospital discharge (whichever comes first)
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At least one episode of delirium from postoperative day 1 through hospital discharge usinc CAM -ICU screening tool
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Postoperative day 7 or Hospital discharge (whichever comes first)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hina Faisal, MD, The Methodist Hospital Research Institute
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
24. april 2026
Primær fullføring (Antatt)
1. mai 2029
Studiet fullført (Antatt)
1. mai 2029
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
11. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00041199
- 1K76AG088424-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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NEI
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