Clinical trial NCT06830369: Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit
Official title: Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Immersive Virtual Reality
Discomfort
IPREA
Intensive Care Unit
Delirium
Keywords: Immersive virtual reality
discomfort
IPREA
intensive care unit
delirium
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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 or at day 5 after IVR initiation. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnea, thirst and sleep deprivation), the 18-item IPREA questionnaire assessed daily from randomization to V1 follow-up visit (ICU discharge or at day 5 after IVR initiation), 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.


Eligibility 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 or next of kin.
* 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

Primary outcomes:
measure: IPREA questionnaire value
timeFrame: day 5
Secondary outcomes:
measure: discomfort symptoms score
timeFrame: day 5
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References: