Health TrialsbyHealthPanel

Virtual Reality for ICU Delirium Prevention

ConditionICU Delirium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality therapeutics

    Device

    Patients will receive daily VR sessions for up to 5 days in addition to regular delirium prevention measures in the ICU

Treatment groups

822 Participants
are divided into 2 treatment groups
Group A: Standard ICU delirium preventionNo intervention 0 interventions
Group B: Study ICU Delirium Prevention and VR treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of ICU Delirium

Using the CAM-ICU assessment, patients will be evaluated for the development of ICU delirium

Time frame
From enrollment in the study until ICU discharge. Assessed Day 1 in the morning and evening for the duration of the ICU admission, up to 24 months from enrollment.

Secondary outcomes

1

Duration of ICU delirium

Number of days the patient experienced ICU delirium while admitted to the ICU

Time frame
From the time of study enrollment until the time of discharge from the ICU, up to 24 months from enrollment.
2

ICU-LOS

ICU length of stay

Time frame
From time admitted to the ICU until discharge from the ICU, up to 24 months from enrollment.
3

H-LOS

Hospital Length of stay

Time frame
From time admitted to the hospital until discharge from the hospital, up to 24 months from enrollment.
4

Acceptability by patients

Able to complete VR sessions as detailed in the study

Time frame
From time enrolled in the study until the patient has completed the study interventions (either on discharge from the ICU or after 5 days of interventions, whichever comes first), from Day 1 until Day 5 after enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov
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