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NCT Number: NCT05525702

VR Interventions to Reduce the Prevalence of Delirium in ICU Patients

The goal of this clinical trial is to learn the effect of Virtual Reality Family Support System (VRFS) on reducing delirium in ICU mechanically ventilated patients. The main question it aims to answer is:

·Using VRFS for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes?

Researchers will investigate whether the implementation of VRFS can reduce the number of delirium days and improve clinical outcomes.

Participants will:

* Receive the VRFS intervention until the endotracheal tube (ETT) is removed. * Have physiological data collected, including EEG, oxygen saturation levels, ECG, and blood pressure. * Keep a diary of delirium, dosage of sedative and analgesic drugs, the duration of mechanical ventilation, and ICU stays.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

During the VRFS interventions, researchers will fit participants with a VR headset and noise-canceling headphones, shielding them from the ICU environment while allowing family members to be present and offer companionship and comfort.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mechanical ventilation duration is expected to be greater than 24 hours;
  • ICU stay duration is expected to be greater than 72 hours;
  • Age is 18 years or older, with no upper age limit;
  • Language: Chinese. Exclusion Criteria
  • Severe visual or auditory impairments (diplopia, low vision due to macular degeneration, retinopathy; severe hearing loss or deafness);
  • Cognitive and consciousness disturbances prior to ICU admission;
  • Severe motion sickness;
  • Head trauma or surgery that prevents the wearing of equipment;
  • A history of long-term use of antipsychotic and/or benzodiazepine medications.

Treatment and study plan

VRFS

Device

Participants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.

Primary outcomes

  1. Delirium Day

    Time frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.

    Delirium is monitored and evaluated by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU has four items ((1) altered mental status/fluctuating course, (2)inattention, (3) altered level of consciousness, and (4) disorganized thinking) and each item has two factors (positive or negative). The physicians can diagnose the patients with delirium when the results of item (1), item (2), and item (3) or item (4) are positive.

Secondary outcomes

  1. ICU Days

    Time frame: From ICU admission through ICU discharge, an average of 7 days.

    The ICU stays are daily recorded by the physicians and nurses in ICU.

  2. Duration of Mechanical Ventilation

    Time frame: From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.

    The duration of mechanical ventilation is daily recorded by the physicians and nurses.

  3. Dosage of sedative and analgesic drugs

    Time frame: Daily from Day 1 through ICU discharge, an average of 7 days.

    Daily records by doctors and nurses.

  4. Incidence of Delirium

    Time frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.

    The proportion of participants who experience at least one CAM-ICU-positive episode during their ICU stay, assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

  5. Family Satisfaction with Care in the Intensive Care Unit (FS-ICU)

    Time frame: At baseline (Day 0) and within 3 days after ICU discharge.

    Family satisfaction is assessed using the FS-ICU scale, evaluating satisfaction with nursing care (FS-Care) and the decision-making process (FS-DM). The results include the total score (FS-Total) and two subscale scores (FS-Care and FS-DM).

Other outcomes

  1. Electroencephalogram (EEG)

    Time frame: At baseline (Day 0) and within 3 days after ICU discharge.

    A wearable headset device was utilized to obtain consistent and adequate quality EEG data.

  2. Oxygen saturation level

    Time frame: At baseline (Day 0) and within 3 days after ICU discharge.

    The oxygen saturation level (SpO2, %) will be collected from a bedside monitor before the intervention.

  3. Blood pressure

    Time frame: At baseline (Day 0) and within 3 days after ICU discharge.

    The blood pressure(mmHg) will be collected from a bedside monitor after the intervention. Both Systolic and Diastolic Blood Pressure will be measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Yingying Yang, MD

CONTACT

[email protected]

+8618800173833

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients With Mechanical Ventilation

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2022
Registry last updated
Mar 27, 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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