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

NCT ID: NCT06414239

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-12-31

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.

Conditions

Digestive System Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Interventional group

Coloscopy with a virtual reality mask

Group Type: EXPERIMENTAL

Use of a VR mask

Intervention Type: DEVICE

Virtual reality mask

Control group

Coloscopy without any premedication or anesthesia

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Without any premedication or anesthesia

Interventions

Use of a VR mask

Virtual reality mask

Intervention Type: DEVICE

Standard of care

Without any premedication or anesthesia

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

My-Linh TRAN-MINH, Dr

Role: CONTACT

mylinh.tranminh@aphp.fr

+33142499597

Jérôme Lambert, Pr

Role: CONTACT

jerome.lambert@u-paris.fr

+33142499742

Other Identifiers

APHP220675

Identifier Type: -

Identifier Source: org_study_id