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

Not Applicable

Not yet recruiting

• Conditions: Delirium; Randomised Controlled Trial; Intensive Care Unit
• Interventions: Device: VR-based intervention

• Registration Number: NCT06153472
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-22
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-01
• Study Start: 2024-01
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR-based sensory stimulation	VR-based intervention	Participants in the experimental group will receive VR-based sensory stimulation.

Primary Outcome Measures

Name	Time	Method
Delirium incidence, duration and severity	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.	Delirium incidence means the number of patients who are delirious and delirium duration means the number of days that a patient is delirious.

Secondary Outcome Measures

Name	Time	Method
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.	The 17-item PTSD Checklist (PCL) correspond to the DSM-III-R symptoms of PTSD and serves as a self-report scale for assessing PTSD
cognitive function	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	Cognitive-FIM (Functional Independence Measure) will be used to measure the cognitive function.
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.	Medical outcomes will be extracted by the outcome assessor from the electronic health care system upon participants' discharge.
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.	The Richards-Campbell Sleep Questionnaire (RCSQ) is employed to assess the sleep quality of ICU patients.
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.	The ICU-Memory Tool (ICU-M) will be used to measure ICU patients' ICU experience
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	The EuroQol- 5 Dimension (EQ-5D) will be used to assess the participants' quality of life.
Independence function	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	Motor-FIM (Functional Independence Measure) will be used to measure the independence function.