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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06153472
Other study ID # 2023K089
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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