Delirium Clinical Trials

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Virtual Reality-based Sensory Stimulation for Delirium Prevention in Intensive Care Units: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate whether virtual reality (VR)-based sensory stimulation can help prevent delirium in adult intensive care unit (ICU) patients, compared with an active control condition delivering the same nature-based audiovisual content via a tablet. The main questions it aims to answer are: 1. Does VR-based sensory stimulation delay the time to the first delirium event during ICU stay? 2. Does VR-based sensory stimulation reduce delirium incidence, duration, and severity? 3. What are the effects of the intervention on ICU length of stay, duration of mechanical ventilation, cognitive function at 3 months after ICU discharge, and health-related quality of life? Researchers will compare immersive VR-based sensory stimulation with a non-immersive tablet-based active control to assess the added value of immersion beyond the effects of sensory content alone. Participants will: 1. Receive either immersive VR-based sensory stimulation or tablet-based sensory stimulation 2. Receive one 20-minute session per day for up to 3 days during ICU stay Undergo twice-daily delirium assessments during ICU stay Complete follow-up assessments of cognitive function and health-related quality of life at 3 months after ICU discharge

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Admitted to the ICU

• Undergoing or expected to require mechanical ventilation

• Expected ICU stay of at least 48 hours

• Awake or lightly sedated, defined as a Richmond Agitation-Sedation Scale - (RASS) score between -1 and +1

• Able to understand and follow instructions

• Provided informed consent \[or surrogate consent, if applicable\]

Locations
Other Locations
China
Southern Medical University Shenzhen Hospital, Peking University Shenzhen Hospital, Shenzhen People's Hospital
RECRUITING
Shenzhen
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 300
Treatments
Experimental: immersive VR group
Participants received immersive VR-based sensory stimulation delivered through a head-mounted display with over-ear headphones. The intervention consisted of nature-based audiovisual content delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
Active_comparator: active control group
Participants received the same nature-based audiovisual content delivered through a tablet-based non-immersive format. Sessions were delivered at the bedside by trained ICU nurses for 20 minutes once daily for up to 3 days.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov