Effectiveness of a Virtual Reality-Based Sensory Stimulation Intervention in Preventing Delirium in Intensive Care Units

NCT06153472 | Not Yet Recruiting

• 1 other identifier: 2023K089
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of a VR-based sensory stimulation system in preventing ICU delirium in patients. The main questions it aims to answer are: Is the VR-based sensory stimulation system more effective in preventing ICU delirium compared to usual care? Does VR sensory stimulation improve patient psychological well-being and clinical outcomes in the ICU? Participants will: Experimental Group: Engage in VR-based sensory stimulation sessions involving visual or/and auditory stimulation. Control Group: Receive usual care without additional VR-based interventions. Comparison: Researchers will compare the outcomes between the experimental group (receiving VR-based sensory stimulation) and the control group (receiving usual care) to determine the effects of VR sensory stimulation on ICU delirium prevention, as well as its impact on patient psychological well-being and clinical outcomes.

Conditions

Delirium; Intensive Care Unit; Randomised Controlled Trial

Keywords

delirium; intensive care unit; randomised controlled trial; sensory stimulation; virtual reality

Outcome Measures

Primary Outcomes (1)

• Delirium incidence, duration and severity

  Delirium incidence means the number of patients who are delirious and delirium duration means the number of days that a patient is delirious.

  From the date of randomization and continues until either fourteen days have passed, the patient is discharged from the Intensive Care Unit (ICU), or the patient passes away from any cause, whichever comes first.

Secondary Outcomes (7)

• Sleep quality

  From the date of randomization and continues until either fourteen days have passed, the patient is discharged from the Intensive Care Unit (ICU), or the patient passes away from any cause, whichever comes first.

• Post Traumatic Stress Disorder

  At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.

• ICU memory

  At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.

• Patients' clinical outcomes

  At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.

• Participants' quality of life

  Enrollement; At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first; through study completion, an average of 6 month

Study Arms (2)

VR-based sensory stimulation

EXPERIMENTAL

Participants in the experimental group will receive VR-based sensory stimulation.

Device: VR-based intervention

Usual care

NO INTERVENTION

Participants in the control group will receive usual care.

Interventions

VR-based intervention DEVICE

The Virtual Reality-based sensory stimulation intervention will last for up to fourteen days, with all interventions administered by a research team. The primary outcomes will include delirium incidence, duration, and severity. The secondary outcomes will encompass patients' psychological well-being (post-traumatic stress disorder, sleep quality, and ICU memory), patients' clinical outcomes, and other outcomes (quality of life, independence, and cognitive function).

VR-based sensory stimulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All ICU patients admitted to the study setting will be recruited if they are have: (1) ≥ 18 years, (2) the first time admitted to ICU and (3) a Richmond Agitation-Sedation Scale (RASS) score ≥-3

You may not qualify if:

• Patients will be excluded if they have: (1) been diagnosed with dementia, delirium or acute psychiatric illness at admission, (2) been diagnosed with end-stage cancer, (3) severe hearing impairment and cannot be corrected by hearing aids and (4) been admitted to ICU with radioactive material.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Shenzhen Hospital of Southern Medical University: collaborator
• Peking University Shenzhen Hospital: collaborator

Related Publications (1)

• Liang S, Liu Y, Wen T, Luo D, He M, Tian J. Effectiveness of a virtual reality-based sensory stimulation intervention in preventing delirium in intensive care units: a randomised-controlled trial protocol. BMJ Open. 2025 Jan 15;15(1):e083966. doi: 10.1136/bmjopen-2024-083966.

  PMID: 39819916 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 2

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 1, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 1, 2023

Record last verified: 2023-11