Health TrialsbyHealthPanel

Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units

ConditionDelirium in the Intensive Care Unit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Admitted to the ICU

Undergoing or expected to require mechanical ventilation

Expected ICU stay of at least 48 hours

Disqualifiers

Pre-existing cognitive impairment or dementia

Acute psychiatric illness at admission

Delirium at enrollment as assessed by CAM-ICU

Terminal-stage cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • immersive VR group

    Device

    Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.

  • Active control group

    Behavioral

    Participants received the same nature-based audiovisual content through a tablet in a non-immersive format for 20 minutes once daily for up to 3 days during ICU stay.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: immersive VR groupExperimental treatment 1 intervention
Group B: active control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to First Delirium Event During ICU Stay

Time from study enrollment to the first episode of delirium detected by the Confusion Assessment Method for the ICU (CAM-ICU).

Time frame
Every day, from ICU admission to ICU discharge, assessed up to 28 days

Secondary outcomes

1

Delirium Incidence

Proportion of participants who developed delirium during ICU stay as assessed by CAM-ICU.

Time frame
Every day, from ICU admission to ICU discharge, assessed up to 28 days
2

Delirium Duration

Total number of days during which delirium was present during ICU stay.

Time frame
Every day, from ICU admission to ICU discharge, assessed up to 28 days
3

ICU Length of Stay

Total number of days from ICU admission to ICU discharge.

Time frame
From date of ICU admission until the date of ICU discharge, assessed up to 28 days
4

Duration of Mechanical Ventilation

Total duration of mechanical ventilation during ICU stay.

Time frame
From date of randomization until the date of first successful liberation from mechanical ventilation or date of in-hospital death, whichever came first, assessed up to 28 days

Other outcomes

Sponsors and contacts

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

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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