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

NCT06414239 | Not Yet Recruiting

• 1 other identifier: APHP220675
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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

Keywords

Lower digestive endoscopy whatever the indication; Digestive endoscopy; Colonoscopy; Virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Maximum pain assessed by the patient by numerical scale

  At day 0

• Maximum pain assessed by the patient by numerical scale

  At 1 month

• Maximum anxiety assessed by the patient by numerical scale

  At day 0

• Maximum anxiety assessed by the patient by numerical scale

  At 1 month

• Patient's opinion to repeat the examination under the same conditions

  At day 0

Study Arms (2)

Interventional group

EXPERIMENTAL

Coloscopy with a virtual reality mask

Device: Use of a VR mask

Control group

OTHER

Coloscopy without any premedication or anesthesia

Other: Standard of care

Interventions

Use of a VR mask DEVICE

Virtual reality mask

Interventional group

Standard of care OTHER

Without any premedication or anesthesia

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

My-Linh TRAN-MINH, Dr

CONTACT

+33142499597; mylinh.tranminh@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 1:1

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-04