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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
194
In the intervention group, after extubation, patients will receive IVR with HypnoVR®, twice-a-day over two to five days. The product consists of HypnoVR® virtual reality software and HypnoVR® Compagnon remote control software. HypnoVR® is a CE-marked class 1 medical device, developed and marketed by HypnoVR SAS, an ISO 13484:2016 and ISO 27001:2017 certified company. The device works with a virtual reality headset, a personal audio device and a mobile terminal. The investigators will only use sessions of 10 to 20 minutes. For each type of session, a visual universe, a musical atmosphere and a male or female voice are defined. Typically, the scenarios include 3 phases: preparation, hypnosis and return. We will use the following sessions: anxiety, pain, rehabilitation.
usual health care
CHRU Amiens
Amiens, France
RECRUITINGIPREA questionnaire value
The primary endpoint will be the 18-item IPREA questionnaire on the day of ICU discharge from intensive care. Each item of the questionnaire includes factors such as noise, light, bed, sleep, thirst, hunger, cold, heat, pain, medical device, intimacy, anxiety, isolation, visiting hours, phone, information, breath and depression. It represents a valid French questionnaire on self-perceived discomfort in intensive care, which is the only discomfort assessment instrument validated for use in the ICU.
Time frame: at the day of ICU-discharge from intensive care, within 5 days
Intensity of discomfort symptoms
The intensity of the following discomfort symptoms assessed on the day of discharge from intensive care (within 5 days) : anxiety, pain, dyspnea, thirst and sleep deprivation. The intensity of these discomforts will be assessed using a NRS ranging from 0 to 10 (0 = no discomfort; 10 = worst possible symptom).
Time frame: at the day of ICU-discharge from intensive care, within 5 days
Delirium incidence
The incidence of delirium measured using the CAM-ICU and RASS scale, daily until discharge from intensive care. RASS is the Richmond agitation \& sedation scale (RASS) The RASS score ranges from a score of -5, where a patient is deemed "unarousable", to a score of +4, where a patient is "violent and immediate danger to staff". If the RASS score is too low (less than -3), meaning that the patient is too drowsy or sedated, then the CAM-ICU cannot be performed . CAM-ICU is : The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool specifically designed to assess for delirium in the context of ICU patients, including those on mechanical ventilation. The final CAM-ICU- score is positive for delirium or negative for delirium.
Time frame: daily until ICU discharge (within 5 days)
Cumulative opioid consumption (morphine or oxycodone)
Cumulative opioid consumption (morphine or oxycodone) expressed in milligrams at discharge from intensive care,
Time frame: At ICU discharge day (within 5 days)
Length of stay (in days)
Length of stay is defined in days between admission to intensive care and discharge from the hospital.
Time frame: At ICU discharge day (within 5 days)
Anxiety and depression at 1 month
Anxiety and depression at 1 month (V2 follow-up visit) after discharge from intensive care using the HAD scale. HAD scale is : Hospital Anxiety and Depression Scale (HADS) is a 14-item scale, with seven items relating to anxiety and seven relating to depression. Scores are : 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Time frame: at 1 month after discharge from intensive care
Patient experience score
Patient experience of device use on discharge from intensive care, using a numeric scale from 1 to 5. 1. Dissatisfied / did not wish to repeat the experience 2. Not very satisfied with the experience 3. Moderately satisfied with the experience 4. Satisfied with the experience 5. Very satisfied / Would like to repeat the experience
Time frame: At ICU discharge day (within 5 days)
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