Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HypnoVR, usual health care.
- Who it may be relevant to
- Registry conditions: Immersive Virtual Reality, Discomfort, IPREA, Intensive Care Unit. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device HypnoVR
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 se - Other usual health care
usual health care
Primary outcome measures
- IPREA questionnaire value [Time frame: at the day of ICU-discharge from intensive care, within 5 days]
Secondary outcome measures (6)
- Intensity of discomfort symptoms [Time frame: at the day of ICU-discharge from intensive care, within 5 days]
- Delirium incidence [Time frame: daily until ICU discharge (within 5 days)]
- Cumulative opioid consumption (morphine or oxycodone) [Time frame: At ICU discharge day (within 5 days)]
- Length of stay (in days) [Time frame: At ICU discharge day (within 5 days)]
- Anxiety and depression at 1 month [Time frame: at 1 month after discharge from intensive care]
- Patient experience score [Time frame: At ICU discharge day (within 5 days)]
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.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- CHRU Amiens — Amiens
Publications
- Huette P, Malaquin S, Lefebvre T, Devos C, Ibrahima A, Daumin C, Coupez A, Josse E, Besserve P, Haye G, Bayart G, Guilbart M, Gibert L, Beyls C, Dupont H, Meynier J, Diouf M, Mahjoub Y, Abou-Arab O. 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, randomised contro PMID 40675645
Identifiers
NCT: NCT06830369 · PI2024_843_0082