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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Digestive System Disease

Treatments: Other: Standard of care; Device: Use of a VR mask

Study type: Interventional

Funder types: Other

Identifiers

NCT06414239

APHP220675

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Interventional group

Experimental group

Description:

Coloscopy with a virtual reality mask

Treatment:

Device: Use of a VR mask

Control group

Other group

Description:

Coloscopy without any premedication or anesthesia

Treatment:

Other: Standard of care