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

September 3, 2026 updated by: Liang Surui, Chinese University of Hong Kong

Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units: A Randomized Controlled 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518133
        • Recruiting
        • Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Delirium Event During ICU Stay
Time Frame: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Time from study enrollment to the first episode of delirium detected by the Confusion Assessment Method for the ICU (CAM-ICU).
Every day, from ICU admission to ICU discharge, assessed up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium Incidence
Time Frame: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Proportion of participants who developed delirium during ICU stay as assessed by CAM-ICU.
Every day, from ICU admission to ICU discharge, assessed up to 28 days
Delirium Duration
Time Frame: Every day, from ICU admission to ICU discharge, assessed up to 28 days
Total number of days during which delirium was present during ICU stay.
Every day, from ICU admission to ICU discharge, assessed up to 28 days
ICU Length of Stay
Time Frame: From date of ICU admission until the date of ICU discharge, assessed up to 28 days
Total number of days from ICU admission to ICU discharge.
From date of ICU admission until the date of ICU discharge, assessed up to 28 days
Duration of Mechanical Ventilation
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
Total duration of mechanical ventilation during ICU stay.
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
Cognitive Function at 3 Months
Time Frame: 3 months after ICU discharge
Cognitive function assessed by the telephone-based Montreal Cognitive Assessment (t-MoCA).
3 months after ICU discharge
Health-Related Quality of Life at 3 Months
Time Frame: 3 months after ICU discharge
Health-related quality of life assessed by the EuroQol Five Dimensions Questionnaire (EQ-5D).
3 months after ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

August 14, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYSZYYEC20230074R003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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