VR-Based Cognitive Stimulation Games for Delirium Prevention

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Feasibility of the trial and VR-based cognitive stimulation intervention [Срок оценки: At Postoperative day 7 or Hospital discharge (whichever comes first)]
• Adherence of VR-based cognitive stimulation intervention [Срок оценки: Baseline to Postoperative day 7 or Hospital discharge (whichever comes first)]
• Safety of VR-based cognitive stimulation intervention [Срок оценки: Postoperative day 1 -3]
• Acceptability of VR-based cognitive stimulation intervention [Срок оценки: At Postoperative day 7 or Hospital discharge (whichever comes first)]
• Usability of VR-based cognitive stimulation intervention [Срок оценки: At Postoperative day 7 or Hospital discharge (whichever comes first)]

Вторичные конечные точки (5)

• Months backward test, pre-intervention [Срок оценки: At Post operative day 1]
• Months backward test, post-intervention [Срок оценки: At Post-operative Day 3]
• NIH Flanker test, pre-intervention [Срок оценки: At Post operative day 1]
• NIH Flanker test, post-intervention [Срок оценки: At Post operative day 3]
• VR games performances [Срок оценки: At Postoperative day 1, 2 and 3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• Houston Methodist Hospital — Houston
• Houston Methodist Research Insititute — Houston

Идентификаторы

NCT: NCT07641153 · Pro00041199 · 1K76AG088424-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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