Delirium, Delirium - Postoperative, Surgery
Conditions
Brief summary
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
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.
OTHERVirtual 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.
OTHERNurse led control arm
Reality orientation therapy focused on time, place, and person, administered twice daily, typically at the beginning and end of nursing shifts.
Sponsors
The Methodist Hospital Research Institute
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the trial and VR-based cognitive stimulation intervention | 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 |
| Adherence of VR-based cognitive stimulation intervention | Baseline to Postoperative day 7 or Hospital discharge (whichever comes first) | Number screened, consented, enrolled, and administered VR |
| Safety of VR-based cognitive stimulation intervention | Postoperative day 1 -3 | adverse event |
| Acceptability of VR-based cognitive stimulation intervention | At Postoperative day 7 or Hospital discharge (whichever comes first) | Behavioral intention scale score |
| Usability of VR-based cognitive stimulation intervention | At Postoperative day 7 or Hospital discharge (whichever comes first) | System usability scale score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Months backward test, pre-intervention | At Post operative day 1 | Measurement of attention and working memory (Cognitive outcome) |
| Months backward test, post-intervention | At Post-operative Day 3 | Measurement of attention and working memory |
| NIH Flanker test, pre-intervention | At Post operative day 1 | Measurement of attention and working memory (Cognitive outcome) |
| NIH Flanker test, post-intervention | At Post operative day 3 | Measurement of attention and working memory (Cognitive outcome) |
| VR games performances | At Postoperative day 1, 2 and 3 | Measurement of attention and working memory (Cognitive outcome) |
Countries
United States
Contacts
CONTACTHina Faisal, MD
PRINCIPAL_INVESTIGATORHina Faisal, MD
The Methodist Hospital Research Institute
Outcome results
None listed