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

Sponsor
Chinese University of Hong Kong
Study ID
NCT06153472
Status
Not Yet Recruiting

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Conditions

  • Delirium
  • Intensive Care Unit
  • Randomised Controlled Trial

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • VR-based intervention — DEVICE
    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).

Study Details

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.

Key Dates

First listed
Dec 1, 2023
Start date
Jan 31, 2024
Status verified
Nov 2023
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

Delirium incidence, duration and severity [ Time Frame: 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. ]

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