ClinicalTrials.gg
RecruitingNCT07806422Updated Sep 8, 2026

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

An interventional study of immersive VR group and Active control group in Delirium in the Intensive Care Unit, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2026, registered Aug 2026).
  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the detailed description

Delirium is a common acute neurocognitive disorder in critically ill patients and is associated with poor short- and long-term outcomes, including prolonged ICU stay, extended mechanical ventilation, persistent cognitive impairment, and reduced quality of life after discharge. Environmental factors in the ICU, particularly sensory deprivation and excessive noise and light disturbance, are recognized as modifiable contributors to delirium risk.

Conventional sensory stimulation has shown potential to delay delirium onset and reduce delirium severity in ICU patients. However, implementation in routine ICU practice is challenging because intervention delivery may be disrupted by the complex ICU environment and may vary across clinical staff and settings.

This study evaluates a virtual reality (VR)-based sensory stimulation intervention designed to provide immersive visual and auditory input while reducing interference from the ICU environment. The intervention uses a head-mounted display and headphones to deliver standardized nature-based content. An active control condition was selected to receive the same content through a tablet, allowing comparison of immersive versus non-immersive delivery while controlling for the sensory content itself.

This study is a pilot randomized controlled trial conducted in adult ICU patients. Participants are randomly assigned in a 1:1 ratio to either the VR intervention group or the active control group. Both groups receive one 20-minute session daily for up to 3 days during ICU stay. Delirium is assessed twice daily during ICU stay, and participants are followed at 3 months after ICU discharge for cognitive and quality-of-life outcomes. The study is intended to generate preliminary estimates of intervention effects and to inform the design of a future definitive trial.

02

Conditions studied

  • Delirium in the Intensive Care Unit

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Keywords

  • delirium
  • ICU
  • prevention
  • sensory stimulation
  • VR
03

In context

Delirium

933 studies on the registry are indexed under Delirium; 190 are open to participants now.

This study's planned enrollment of 300 is above the median of 112 across 550 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 [or surrogate consent, if applicable]

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    immersive VR group

    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.

    Device: immersive VR group

  • Active comparator
    active control group

    Participants received the same nature-based audiovisual content delivered through a tablet-based non-immersive format. Sessions were delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.

    Behavioral: Active control group

Interventions

  • Deviceimmersive VR group

    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.

  • BehavioralActive control group

    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.

06

What researchers measure

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

  5. Cognitive Function at 3 Months

    Cognitive function assessed by the telephone-based Montreal Cognitive Assessment (t-MoCA).

    Time frame: 3 months after ICU discharge

  6. Health-Related Quality of Life at 3 Months

    Health-related quality of life assessed by the EuroQol Five Dimensions Questionnaire (EQ-5D).

    Time frame: 3 months after ICU discharge

07

Study locations

1 of 1 sites recruiting
  • Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital
    Shenzhen, Guangdong 518133, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07806422
Responsible party
Liang Surui (Principal Investigator, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 8, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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