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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Другое usual health care
  usual health care

Первичные конечные точки

• IPREA questionnaire value [Срок оценки: at the day of ICU-discharge from intensive care, within 5 days]

Вторичные конечные точки (6)

• Intensity of discomfort symptoms [Срок оценки: at the day of ICU-discharge from intensive care, within 5 days]
• Delirium incidence [Срок оценки: daily until ICU discharge (within 5 days)]
• Cumulative opioid consumption (morphine or oxycodone) [Срок оценки: At ICU discharge day (within 5 days)]
• Length of stay (in days) [Срок оценки: At ICU discharge day (within 5 days)]
• Anxiety and depression at 1 month [Срок оценки: at 1 month after discharge from intensive care]
• Patient experience score [Срок оценки: At ICU discharge day (within 5 days)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHRU Amiens — Amiens

Публикации

• 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

Идентификаторы

NCT: NCT06830369 · PI2024_843_0082

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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