Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit

Recruiting now · Not applicable

Conditions studied: Immersive Virtual Reality, Discomfort, IPREA, Intensive Care Unit, Delirium

In brief

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.

Key facts

Study ID

NCT06830369

Run by

Centre Hospitalier Universitaire, Amiens

People needed

194

Starts

2025-09-12

Expected to finish

2027-10-01

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• CHRU Amiens — Amiens, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.