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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06153472
• Other study ID #: 2023K089
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 324
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit
• Randomised Controlled Trial

Intervention

Device:
• VR-based intervention
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).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Peking University Shenzhen Hospital, Shenzhen Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sleep quality	The Richards-Campbell Sleep Questionnaire (RCSQ) is employed to assess the sleep quality of ICU patients.	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	Post Traumatic Stress Disorder	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	At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
Secondary	ICU memory	The ICU-Memory Tool (ICU-M) will be used to measure ICU patients' ICU experience	At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
Secondary	Patients' clinical outcomes	Medical outcomes will be extracted by the outcome assessor from the electronic health care system upon participants' discharge.	At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
Secondary	Participants' quality of life	The EuroQol- 5 Dimension (EQ-5D) will be used to assess the 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
Secondary	Independence function	Motor-FIM (Functional Independence Measure) will be used to measure the 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
Secondary	cognitive function	Cognitive-FIM (Functional Independence Measure) will be used to measure the 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