Clinical trial NCT06414239: Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask
Official title: Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Digestive System Disease
Keywords: Lower digestive endoscopy whatever the indication
Digestive endoscopy
Colonoscopy
Virtual reality
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of cecal intubation
timeFrame: At day 0
Secondary outcomes:
measure: Maximum pain assessed by the patient by numerical scale
timeFrame: At day 0
measure: Maximum pain assessed by the patient by numerical scale
timeFrame: At 1 month
measure: Maximum anxiety assessed by the patient by numerical scale
timeFrame: At day 0
measure: Maximum anxiety assessed by the patient by numerical scale
timeFrame: At 1 month
measure: Patient's opinion to repeat the examination under the same conditions
timeFrame: At day 0
measure: Patient's opinion to repeat the examination under the same conditions
timeFrame: At 1 month
measure: Duration of the examination
timeFrame: At day 0
measure: Total duration of the procedure
timeFrame: At day 0
measure: Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum
timeFrame: At day 0
measure: Proportion of procedures where the VR mask is removed at the patient's request
timeFrame: Up to 30 months
measure: Proportion of colonoscopies with detection of at least one adenoma
timeFrame: Up to 30 months
measure: Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group
timeFrame: Up to 30 months
measure: Operator satisfaction
timeFrame: Up to 30 months
measure: Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success
timeFrame: Up to 30 months
Other outcomes:
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