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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06153472

Collaborator

Shenzhen Hospital of Southern Medical University (Other), Peking University Shenzhen Hospital (Other)

324

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium Intensive Care Unit Randomised Controlled Trial	Device: VR-based intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcome assessors will be blinded.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VR-based sensory stimulation Participants in the experimental group will receive VR-based sensory stimulation.	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).
No Intervention: Usual care Participants in the control group will receive usual care.

Arm

Intervention/Treatment

Experimental: VR-based sensory stimulation

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

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).

No Intervention: Usual care

Participants in the control group will receive usual care.

Outcome Measures

Primary Outcome Measures

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

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.
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
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
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.