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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 194
- Locations
- 1
- Primary Endpoint
- IPREA questionnaire value
Study Overview
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. 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
intervention group
Intervention: HypnoVR (Device)
standard group
Intervention: usual health care (Other)
Outcomes
Primary Outcomes
IPREA questionnaire value
Time Frame: at the day of ICU-discharge from intensive care, within 5 days
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.
Secondary Outcomes
- Length of stay (in days)(At ICU discharge day (within 5 days))
- Intensity of discomfort symptoms(at the day of ICU-discharge from intensive care, within 5 days)
- Cumulative opioid consumption (morphine or oxycodone)(At ICU discharge day (within 5 days))
- Anxiety and depression at 1 month(at 1 month after discharge from intensive care)
- Patient experience score(At ICU discharge day (within 5 days))
- Delirium incidence(daily until ICU discharge (within 5 days))