Virtual Reality for ICU Delirium Prevention

Cedars-Sinai Medical Center

Status

Not yet enrolling

Conditions

ICU Delirium

Treatments

Device: Virtual Reality therapeutics

Study type

Interventional

Funder types

Other

Identifiers

NCT07357389

STUDY00004538

Details and patient eligibility

About

The purpose of this study is to evaluate whether daily exposure to immersive virtual reality (VR) can reduce the incidence of delirium in high-risk, non-intubated ICU patients. Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming natural scenes, guided meditation, and music. The study population includes adult surgical ICU patients at Cedars-Sinai who are CAM-ICU negative at enrollment and possess at least one established risk factor for delirium. Outcomes will include the incidence and duration of delirium, ICU and hospital length of stay, feasibility of the VR intervention, and the frequency of adverse events. By targeting a high-risk population with an innovative non-pharmacologic therapy, this trial aims to generate data to support integration of VR into ICU delirium prevention protocols.

Enrollment

822 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Individuals who are currently admitted to the SICU at Cedars-Sinai Medical Center
Expected ICU stay >48 hours
Richmond Agitation Sedation Scale (RASS) score between -1 to +2.
CAM-ICU negative
1≤ risk factor for delirium (Age ≥ 65 years old, history of cognitive impairment, sepsis, Sequential Organ Failure Assessment (SOFA) score >5, history of alcohol or benzodiazepine abuse, recent major surgery)

Exclusion criteria

Unwilling and/or unable to participate
Intubation of tracheostomy
Self-reported history of severe motion sickness
Inability to follow commands (e.g. severe aphasia, deafness, GCS<13)
The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted device (HMD
Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses
Having had a seizure in the past year
Unable to understand the instructions or to consent to participation in the study.
Those who are pregnant
Hemodynamic instability (MAP<65 despite support)
End-of-life care
Severe agitation or delirium (i.e. CAM-ICU + screen)