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

Centre Hospitalier Universitaire, Amiens

Status: Not yet enrolling

Conditions: IPREA; Delirium; Intensive Care Unit; Discomfort; Immersive Virtual Reality

Treatments: Device: HypnoVR; Other: usual health care

Study type: Interventional

Funder types: Other

Identifiers

NCT06830369

PI2024_843_0082

Details and patient eligibility

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 2 patient groups

standard group

Active Comparator group

Treatment:

Other: usual health care

intervention group

Experimental group

Treatment:

Device: HypnoVR