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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
CHRU Amiens
RECRUITING
Amiens
Contact Information
Primary
Colin DEVOS
Devos.colin@chu-amiens.fr
33+322087899
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2027-10
Participants
Target number of participants: 194
Treatments
Active_comparator: standard group
Experimental: intervention group
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov