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

Study Overview
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Brief Summary
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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.

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

Conditions
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Delirium, Intensive Care Unit, Randomised Controlled Trial

Intervention / Treatment
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* Device: VR-based intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-based sensory stimulation<br>Participants in the experimental group will receive VR-based sensory stimulation. | Device: VR-based intervention<br>* 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).<br>|
| No Intervention: Usual care<br>Participants in the control group will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care unit, randomised controlled trial, sensory stimulation, virtual reality, delirium