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

Digestive System Disease Clinical Trial

— REVENDO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06414239
• Other study ID #: APHP220675
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: My-Linh TRAN-MINH, Dr
• Phone: +33142499597
• Email: mylinh.tranminh[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Device:
• Use of a VR mask
Virtual reality mask

Other:
• Standard of care
Without any premedication or anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

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