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VR-Based Cognitive Stimulation Games for Delirium Prevention

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Houston Methodist Research Insititute
        • Ledende efterforsker:
          • Hina Faisal, MD

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

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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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VR intervention: VR-based cognitive stimulation games
Participants will engage in interactive, VR-based cognitive stimulation games.
Andet: Virtual Reality Software
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.
Eksperimentel: VR Control: watching a movie in VR
Participants will watch a non-interactive VR movie experience consisting of educational material.
Andet: Virtual Reality movies
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.
Eksperimentel: Nurse control: standard-of-care nurse-led reality orientation
Participants will receive standard-of-care, nurse-led reality orientation therapy.
Andet: Nurse led control arm
Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of the trial and VR-based cognitive stimulation intervention
Tidsramme: At Postoperative day 7 or Hospital discharge (whichever comes first)
A composite of recruitment rate, outcomes data completion, usability of VR intervention, acceptance of the VR intervention, and adherence to VR sessions
At Postoperative day 7 or Hospital discharge (whichever comes first)
Adherence of VR-based cognitive stimulation intervention
Tidsramme: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)
Number screened, consented, enrolled, and administered VR
Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)
Safety of VR-based cognitive stimulation intervention
Tidsramme: Postoperative day 1 -3
adverse event
Postoperative day 1 -3
Acceptability of VR-based cognitive stimulation intervention
Tidsramme: At Postoperative day 7 or Hospital discharge (whichever comes first)
Behavioral intention scale score
At Postoperative day 7 or Hospital discharge (whichever comes first)
Usability of VR-based cognitive stimulation intervention
Tidsramme: At Postoperative day 7 or Hospital discharge (whichever comes first)
System usability scale score
At Postoperative day 7 or Hospital discharge (whichever comes first)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Months backward test, pre-intervention
Tidsramme: At Post operative day 1
Measurement of attention and working memory (Cognitive outcome)
At Post operative day 1
Months backward test, post-intervention
Tidsramme: At Post-operative Day 3
Measurement of attention and working memory
At Post-operative Day 3
NIH Flanker test, pre-intervention
Tidsramme: At Post operative day 1
Measurement of attention and working memory (Cognitive outcome)
At Post operative day 1
NIH Flanker test, post-intervention
Tidsramme: At Post operative day 3
Measurement of attention and working memory (Cognitive outcome)
At Post operative day 3
VR games performances
Tidsramme: At Postoperative day 1, 2 and 3
Measurement of attention and working memory (Cognitive outcome)
At Postoperative day 1, 2 and 3

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect size of VR cognitive simulation games on postoperative delirium (Exploratory outcome)
Tidsramme: Postoperative day 7 or Hospital discharge (whichever comes first)
At least one episode of delirium from postoperative day 1 through hospital discharge usinc CAM -ICU screening tool
Postoperative day 7 or Hospital discharge (whichever comes first)

Samarbejdspartnere og efterforskere

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

Sponsor

The Methodist Hospital Research Institute

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Hina Faisal, MD, The Methodist Hospital Research Institute

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)

24. april 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00041199
  • 1K76AG088424-01A1 (U.S. NIH-bevilling/kontrakt)

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