VR-Based Cognitive Stimulation Games for Delirium Prevention
Purpose
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.
Conditions
- Surgery
- Delirium - Postoperative
- Delirium
Eligibility
- Eligible Ages
- Under 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VR intervention: VR-based cognitive stimulation games |
Participants will engage in interactive, VR-based cognitive stimulation games. |
|
|
Experimental VR Control: watching a movie in VR |
Participants will watch a non-interactive VR movie experience consisting of educational material. |
|
|
Experimental Nurse control: standard-of-care nurse-led reality orientation |
Participants will receive standard-of-care, nurse-led reality orientation therapy. |
|
Recruiting Locations
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The Methodist Hospital Research Institute
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.