Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07357389

Virtual Reality for ICU Delirium Prevention in Surgical ICU Patients

Led by Cedars-Sinai Medical Center · Updated on 2026-03-17

822

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether daily exposure to immersive virtual reality (VR) can reduce the occurrence of delirium in high-risk, non-intubated adult patients in the surgical intensive care unit (ICU). This study focuses on patients who are CAM-ICU negative at enrollment and have at least one known risk factor for delirium, such as advanced age, cognitive impairment history, sepsis, or recent major surgery. The goal is to explore a non-drug approach to help prevent delirium in the ICU setting. Participants will be randomly assigned to receive either standard ICU care alone or standard care plus daily 15-minute VR sessions for up to five days. These VR sessions feature calming natural scenes, guided meditation, and music, delivered through a head-mounted device. The study assesses the feasibility of using this VR intervention alongside usual delirium prevention measures. During the study, participants will be monitored daily for delirium using the CAM-ICU assessment, with evaluations in the morning and evening throughout their ICU stay, for up to 24 months after enrollment. Researchers will also track the duration of delirium, length of ICU and hospital stays, patient acceptance of VR sessions, and any adverse events such as nausea or dizziness. Participation involves regular assessments and safety monitoring until hospital discharge or completion of VR sessions.

CONDITIONS

Brief Title

Virtual Reality for ICU Delirium Prevention

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals currently admitted to the surgical ICU at Cedars-Sinai Medical Center
  • Expected ICU stay longer than 48 hours
  • Richmond Agitation Sedation Scale (RASS) score between -1 to +2
  • CAM-ICU negative at enrollment
  • Have at least one risk factor for delirium such as age 65 or older, history of cognitive impairment, sepsis, SOFA score over 5, history of alcohol or benzodiazepine abuse, or recent major surgery
Not Eligible

You will not qualify if you...

  • Unwilling or unable to participate
  • Intubated or have tracheostomy
  • History of severe motion sickness
  • Unable to follow commands (e.g., severe aphasia, deafness, Glasgow Coma Scale under 13)
  • Facial or head deformity preventing use of VR headset
  • Require corrective lenses stronger than -2.5 that cannot be corrected with contact lenses
  • Had a seizure in the past year
  • Unable to understand instructions or consent
  • Pregnant
  • Hemodynamic instability (mean arterial pressure under 65 despite support)
  • Receiving end-of-life care
  • Severe agitation or delirium (positive CAM-ICU screen)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 5 days

Participants receive daily virtual reality sessions for up to 5 days in addition to regular delirium prevention measures in the ICU.

Daily sessions during ICU stay for up to 5 days

Long-term Monitoring

Duration - Up to 24 months

Participants are monitored for incidence and duration of ICU delirium, length of ICU and hospital stay, and adverse events related to VR until ICU or hospital discharge, up to 24 months from enrollment.

Assessments during ICU admission and hospital stay up to 24 months

Trial Site Locations

Total: 1 location

1

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

D

Devon S Callahan, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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