Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask

Официальное название

Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle

Обзор

90% of colonoscopies are performed with general anesthesia (GA). GA carries risks and requires a prior anesthesia consultation, a dedicated team and technical platform on the day of the examination. These constraints increase the time it takes to organize examinations. This was particularly highlighted during the recent health crisis. The success of colonoscopy without GA varies depending on the patient's experience of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact.

Вмешательства

• Устройство Use of a VR mask
  Virtual reality mask
• Другое Standard of care
  Without any premedication or anesthesia

Первичные конечные точки

• Rate of cecal intubation [Срок оценки: At day 0]

Вторичные конечные точки (12)

• Maximum pain assessed by the patient by numerical scale [Срок оценки: At day 0]
• Maximum pain assessed by the patient by numerical scale [Срок оценки: At 1 month]
• Maximum anxiety assessed by the patient by numerical scale [Срок оценки: At day 0]
• Maximum anxiety assessed by the patient by numerical scale [Срок оценки: At 1 month]
• Patient's opinion to repeat the examination under the same conditions [Срок оценки: At day 0]
• Patient's opinion to repeat the examination under the same conditions [Срок оценки: At 1 month]
• Duration of the examination [Срок оценки: At day 0]
• Total duration of the procedure [Срок оценки: At day 0]
• Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum [Срок оценки: At day 0]
• Proportion of procedures where the VR mask is removed at the patient's request [Срок оценки: Up to 30 months]
• Proportion of colonoscopies with detection of at least one adenoma [Срок оценки: Up to 30 months]
• Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group [Срок оценки: Up to 30 months]

Критерии участия

Критерии включения

Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia

Критерии исключения

• Hearing problems or low vision
• Psychiatric or cognitive disorders hindering communication
• History of epilepsy
• Claustrophobia which can lead to a rejection of the virtual reality mask
• History of cybercynetosis during previous use of VR
• Chronic abdominal pain with baseline Visual analogue scale (VAS) > 5
• Emergency examination
• Patient participating in another interventional research on digestive endoscopy
• Patient not speaking French
• Patient under guardianship

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

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06414239 · APHP220675

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗