Virtual reality to prevent delirium in the ICU
VR for ICU Delirium Prevention
This project will try daily 15-minute virtual reality sessions to see if they reduce delirium in high-risk, non-intubated adult surgical ICU patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 822 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07357389 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized intervention in adult surgical ICU patients at Cedars-Sinai who are CAM-ICU negative but have at least one established delirium risk factor. Participants are randomized to standard ICU care or standard care plus once-daily 15-minute immersive VR sessions showing calming nature scenes with guided meditation and music. Outcomes include the incidence and duration of delirium, ICU and hospital length of stay, feasibility of delivering VR in the ICU, and the frequency of adverse events. The intervention targets a high-risk population with a non-pharmacologic approach intended to be simple to deliver at the bedside.
Who should consider this trial
Good fit: Ideal candidates are adult surgical ICU patients at Cedars-Sinai who are non-intubated, CAM-ICU negative at enrollment, expected to stay in the ICU >48 hours, have a RASS between −1 and +2, and have at least one delirium risk factor.
Not a fit: Patients unlikely to benefit include those who are intubated or unable to wear a VR headset, have recent seizures or severe motion sickness, cannot follow commands, or cannot consent or understand instructions.
Why it matters
Potential benefit: If successful, the intervention could lower how often and how long patients experience ICU delirium and potentially shorten ICU and hospital stays using a non-drug therapy.
How similar studies have performed: VR has shown promise for anxiety, pain, and sleep in hospitalized patients and small pilot work suggests potential to reduce delirium risk, but definitive multicenter evidence for ICU delirium prevention is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Devon S Callahan, MD — Cedars-Sinai Medical Center
- Study coordinator: Devon S Callahan, MD
- Email: devon.callahan@cshs.org
- Phone: 310-423-2402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.