Studying How Virtual Reality Using HypnoVR Can Improve Comfort After Major Surgery in the Surgical Intensive Care Unit
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-18
194
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates the effect of immersive virtual reality IVR using HypnoVR on reducing discomfort for patients admitted to a surgical intensive care unit ICU following major surgeries such as cardiac, thoracic, or major abdominal operations. The study aims to assess whether this VR program can help ease discomfort related to the ICU environment and care, which often causes psychological effects. It is a prospective, randomized controlled trial enrolling 194 patients in a single hospital setting.
CONDITIONS
Brief Title
Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit
Research Team
C
Colin DEVOS
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Scheduled for a major cardiothoracic or major abdominal surgery
Provided written informed consent
Admitted to a surgical ICU for postoperative care for at least 48 hours
No delirium at inclusion as assessed by RASS and CAM-ICU scales
You will not qualify if you...
Missing informed consent
Under 18 years old
Participated in another study within the last 30 days
Pregnant or breastfeeding
Emergency hospitalization
Progressive sepsis
Transferred from another intensive care unit
Short-term life-threatening condition
Active psychiatric illness requiring antidepressant, antipsychotic, or anxiolytic treatment
Mechanical ventilation for more than 48 hours
Known cognitive disorders
Uncontrolled epilepsy
Visual or auditory problems preventing virtual reality use
Under guardianship or deprived of liberty
Not registered with the national social security system
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 to 5 days
Participants receive virtual reality sessions with HypnoVR® twice daily after extubation for 2 to 5 days or receive usual health care.
Twice-daily sessions during ICU stay
Follow-up
Duration - 1 month
Participants are assessed for anxiety and depression one month after discharge from intensive care.
1 follow-up visit
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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Published Research Related To This Trial
Effect of a virtual reality program on patient comfort in the surgical intensive care unit of a French university hospital: study protocol for a monocentric, prospective, superiority, randomised controlled trial-ZION study.
Pierre Huette, Stéphanie Malaquin, Thomas Lefebvre...