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Recruiting NCT07641153

VR-Based Cognitive Stimulation Games for Delirium Prevention

No phase Interventional Surgery Delirium - Postoperative Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Software, Virtual Reality movies, Nurse led control arm.
Who it may be relevant to
Registry conditions: Surgery, Delirium - Postoperative, Delirium. Basic parameters: up to 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Virtual Reality-Based Cognitive Stimulation Games for Enhancing Attention and Preventing Delirium in Older Surgical Patients With Cognitive Impairment

Overview

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.

Detailed description

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.

Interventions

  • Other 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.
  • Other 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.
  • Other 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.

Primary outcome measures

  • Feasibility of the trial and VR-based cognitive stimulation intervention [Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)]
  • Adherence of VR-based cognitive stimulation intervention [Time frame: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)]
  • Safety of VR-based cognitive stimulation intervention [Time frame: Postoperative day 1 -3]
  • Acceptability of VR-based cognitive stimulation intervention [Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)]
  • Usability of VR-based cognitive stimulation intervention [Time frame: At Postoperative day 7 or Hospital discharge (whichever comes first)]
Secondary outcome measures (5)
  • Months backward test, pre-intervention [Time frame: At Post operative day 1]
  • Months backward test, post-intervention [Time frame: At Post-operative Day 3]
  • NIH Flanker test, pre-intervention [Time frame: At Post operative day 1]
  • NIH Flanker test, post-intervention [Time frame: At Post operative day 3]
  • VR games performances [Time frame: At Postoperative day 1, 2 and 3]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 2 centers
  • Houston Methodist Hospital — Houston
  • Houston Methodist Research Insititute — Houston

Identifiers

NCT: NCT07641153 · Pro00041199 · 1K76AG088424-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗