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NCT07806422
Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units
Conditions: Delirium in the Intensive Care Unit
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Chinese University of Hong Kong
Location: Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital Shenzhen Guangdong
Summary
The goal of this clinical trial is to evaluate whether virtual reality (VR)-based sensory stimulation can help prevent delirium in adult intensive care unit (ICU) patients, compared with an active control condition delivering the same nature-based audiovisual content via a tablet. The main questions it aims to answer are:
1. Does VR-based sensory stimulation delay the time to the first delirium event during ICU stay?
2. Does VR-based sensory stimulation reduce delirium incidence, duration, and severity?
3. What are the effects of the intervention on ICU length of stay, duration of mechanical ventilation, cognitive function at 3 months after ICU discharge, and health-related quality of life? Researchers will compare immersive VR-based sensory stimulation with a non-immersive tablet-based active control to assess the added value of immersion beyond the effects of sensory content alone.
Participants will:
1. Receive either immersive VR-based sensory stimulation or tablet-based sensory stimulation
2. Receive one 20-minute session per day for up to 3 days during ICU stay Undergo twice-daily delirium assessments during ICU stay Complete follow-up assessments of cognitive function and health-related quality of life at 3 months after ICU discharge
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Admitted to the ICU
* Undergoing or expected to require mechanical ventilation
* Expected ICU stay of at least 48 hours
* Awake or lightly sedated, defined as a Richmond Agitation-Sedation Scale - (RASS) score between -1 and +1
* Able to understand and follow instructions
* Provided informed consent \[or surrogate consent, if applicable\]
Exclusion Criteria:
* Pre-existing cognitive impairment or dementia
* Acute psychiatric illness at admission
* Delirium at enrollment as assessed by CAM-ICU
* Terminal-stage cancer
* APACHE II score \> 20
* Severe uncorrectable hearing or visual impairment
* Traumatic brain injury or intracranial drainage tubes that make use of the VR headset impractical
Source: ClinicalTrials.gov (NCT07806422). StuddyBuddy aggregates publicly available trial information.