Actively Recruiting
Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-18
194
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Admission to a surgical intensive care unit (ICU) following major surgery is associated with a number of discomforts, not only related to the disease itself, but also to the care provided or the ICU environment itself (lights, sounds, pain, sleep deprivation, thirst...). This discomfort is real, and can be associated with psychological consequences. The investigators hypothesized that the use of immersive virtual reality (IVR) with HypnoVR® is feasible and can help reduce discomfort in intensive care.The ZION trial is a prospective, monocentric trial, randomizing 194 patients admitted in a surgical intensive care unit after a major surgery. The inclusion criterion are patients admitted in a surgical intensive care for at least 48 hours following major surgery (cardiac, thoracic or major abdominal surgery). Patients will be allocated to the intervention group (n=97) or the control group (n=97). In the intervention group, patients will receive IVR using HypnoVR®, twice a day, during the ICU stay (2 to 5 days). In the control group, postoperative care will be conducted according to standard cares without IVR. The primary endpoint will be the 18-items IPREA questionnaire on the day of ICU discharge. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnea, thirst and sleep deprivation), incidence of delirium, cumulative morphine consumption at ICU discharge, length of ICU stay, and anxiety or depression at 1 month after discharge from intensive care and patient experience of device use.
CONDITIONS
Official Title
Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Scheduled for major cardiothoracic or major abdominal surgery
- Written informed consent from patient
- Admitted to a surgical ICU for postoperative care for at least 48 hours
- No delirium at inclusion (assessed by RASS and CAM-ICU scales)
You will not qualify if you...
- Missing informed consent
- Patients under 18 years old
- Participation in another study within the last 30 days
- Pregnancy or breastfeeding
- Emergency hospitalization
- Progressive sepsis
- Transfer from another intensive care unit
- Short-term life-threatening condition
- Active psychiatric illness requiring antidepressant, antipsychotic, or anxiolytic treatment
- Mechanical ventilation longer than 48 hours
- Known cognitive disorders
- Uncontrolled epilepsy
- Visual or auditory problems preventing use of virtual reality
- Patients under guardianship or deprived of liberty
- Not registered with the national social security system
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHRU Amiens
Amiens, France, 80054
Actively Recruiting
Research Team
C
Colin DEVOS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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