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NCT Number: NCT07806422

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital

Shenzhen, Guangdong, 518133, China

Location status: Recruiting

Location contact

Liang Judy, PhD

CONTACT

[email protected]

37256297

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Cognitive Function at 3 Months

    Time frame: 3 months after ICU discharge

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

  6. 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).

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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