Clinical trial NCT06153472: Effectiveness of a Virtual Reality-Based Sensory Stimulation Intervention in Preventing Delirium in Intensive Care Units
Official title: Effectiveness of a Virtual Reality-Based Sensory Stimulation Intervention in Preventing Delirium in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium
Intensive Care Unit
Randomised Controlled Trial
Keywords: delirium
intensive care unit
randomised controlled trial
sensory stimulation
virtual reality
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Shenzhen Hospital of Southern Medical University
name: Peking University Shenzhen Hospital
First posted: 2023-12-01
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Delirium incidence, duration and severity
timeFrame: 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 outcomes:
measure: Sleep quality
timeFrame: 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.
measure: Post Traumatic Stress Disorder
timeFrame: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
measure: ICU memory
timeFrame: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
measure: Patients' clinical outcomes
timeFrame: At either the end of the fourteen-day period or when the patient is discharged from the Intensive Care Unit (ICU), whichever comes first.
measure: Participants' quality of life
timeFrame: 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
measure: Independence function
timeFrame: 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
measure: cognitive function
timeFrame: 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
Other outcomes:
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