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Virtual Reality for ICU Delirium Prevention

RecruitingNAAges 18 Years - anyAllCedars-Sinai Medical Center
NCT07357389 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Virtual Reality therapeutics
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Where

1 site
Cedars Sinai Medical Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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