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

Not Applicable

Not yet recruiting

• Conditions: Digestive System Disease
• Interventions: Other: Standard of care; Device: Use of a VR mask

• Registration Number: NCT06414239
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Study Start: 2024-06
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard of care	Coloscopy without any premedication or anesthesia
Interventional group	Use of a VR mask	Coloscopy with a virtual reality mask

Primary Outcome Measures

Name	Time	Method
Rate of cecal intubation	At day 0	Success of a total colonoscopy defined by the rate of cecal intubation (visualization of the ileocecal valve and the appendicular orifice with the endoscope located near the appendicular orifice) or visualization of the ileocecal anastomosis in case of history of surgery removing the ileocaecal valve

Secondary Outcome Measures

Name	Time	Method
Maximum anxiety assessed by the patient by numerical scale	At 1 month	The scale varies from 0 to 10. 0 is no anxiety, 10 is the worst possible anxiety
Maximum pain assessed by the patient by numerical scale	At 1 month	The scale varies from 0 to 10. 0 is no pain, 10 is the worst possible pain
Duration of the examination	At day 0	Time between introduction and removal of the colonoscope
Total duration of the procedure	At day 0	time between entering and leaving the room
Number of minutes from visualization of the valve between the introduction of the colonoscope and 30 minutes maximum	At day 0	Between the introduction of the colonoscope and 30 minutes maximum. It can be the ileum in the event of a history of surgery removing the valve.
Proportion of procedures where the VR mask is removed at the patient's request	Up to 30 months
Proportion of VR device malfunctions (≥ 1) during the procedure in the intervention group	Up to 30 months
Patient's opinion to repeat the examination under the same conditions	At 1 month	It will be assesses by the Likert scale
Proportion of colonoscopies with detection of at least one adenoma	Up to 30 months
Operator satisfaction	Up to 30 months	Assessed by the Analogue Visual Scale examination
Incremental cost effectiveness ratio or incremental cost-result ratio in the form of cost per additional colonoscopic success	Up to 30 months