Virtual reality to improve comfort for adults in the surgical ICU
Official title: 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, Randomized Controlled Trial, With Blinded End-point (PROBE), ZION Study
Run by Centre Hospitalier Universitaire, Amiens · NCT06830369 · Data updated 2026-11-12
This trial will try immersive virtual reality (HypnoVR) sessions to reduce discomfort for adults who stay at least 48 hours in the surgical intensive care unit after major cardiothoracic or abdominal surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 194 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | September 12, 2025 |
| Main results expected | September 2027 |
| Study ends | October 2027 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06830369 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) scheduled for major cardiothoracic or major abdominal surgery who are admitted postoperatively to the surgical ICU for at least 48 hours and are free of delirium at enrollment are the intended participants.
✕Probably not a fit
Patients with visual or auditory impairments preventing VR use, uncontrolled epilepsy, active psychiatric conditions on psychotropic therapy, known cognitive disorders, prolonged mechanical ventilation (>48 hours), emergency admissions, transfers from other ICUs, or pregnancy are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The ZION trial is a prospective, single-center, randomized trial that will enroll 194 postoperative adults admitted to the surgical ICU for at least 48 hours. Participants are randomized 1:1 to receive usual care alone or usual care plus twice-daily immersive virtual reality sessions using HypnoVR during their ICU stay. Discomfort and related outcomes will be measured using standard instruments for ICU discomfort (such as IPREA) and delirium screening (RASS and CAM-ICU), with predefined inclusion and exclusion criteria to ensure safety. The control arm receives standard postoperative ICU care without virtual reality.
Why it matters
Potential benefit: If successful, the intervention could reduce ICU-related discomfort and its psychological consequences, improving patient comfort and the recovery experience.
How similar studies have gone: Smaller pilot and perioperative VR studies have reported reductions in pain, anxiety, and discomfort, but robust randomized data specifically in postoperative ICU populations remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old * scheduled for a major surgery (cardiothoracic surgery or a major abdominal surgery) * Written informed consent from patient. * Admitted in a surgical ICU for a postoperative care for at least 48 hours. * Absence of delirium at inclusion (RASS and CAM-ICU scale) Exclusion Criteria: * Missing informed consent * Patient strictly under 18 years old * Inclusion in other study within the last 30 days * Pregnancy * Emergency hospitalization * Progressive sepsis * Patient transferred from another intensive care unit * Short-term life-threatening condition * Active psychiatric illness requiring antidepressant, antipsychotic or anxiolytic treatment * Mechanical ventilation \> 48 hours * Patient known to have cognitive disorders. * Unbalanced epilepsy * Visual problems (absence of binocular vision, blindness) and/or auditory problems (deafness) preventing the use of virtual reality * Pregnant or breast-feeding women * Patients under guardianship or deprived of their liberty * Patients not registered with the national social security system
Where it's running
-
CHRU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Colin DEVOS
- Email: Devos.colin@chu-amiens.fr
- Phone: 33+322087899
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.