Clinical Trial

Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis: a Randomised Controlled Trial

Study acronym: VIRTU
Recruiting
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Summary
Haemorrhagic rectocolitis is an inflammatory bowel disease that continuously affects the rectum and colon, with lesions that extend variably from the rectum into the upstream colon. This disease requires repeated assessment of both clinical activity (transcribed by the clinical Mayo score) and endoscopic activity. ACCEPT study showed that the acceptability of rectosigmoidoscopy is low, and the main determinants of this low acceptability were pain and bloating (51%) and embarrassment during the examination (30%). Virtual reality headsets has analgesic and anxiolytic properties, thanks to specially designed virtual environments that apply different principles such as medical hypnosis, music therapy and cardiac coherence to enhance therapeutic action. The aim of our project is to study the benefit of medical hypnosis provided by the use of a virtual reality headset in terms of tolerance of lower digestive endoscopy in patients with ulcerative colitis.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-10-07; most recent amendment 2025-07-31.
Status change: Not Yet Recruiting → Recruiting 2024-10-09
Trial Details
NCT Number NCT06632691
Lead Sponsor Centre Hospitalier Departemental Vendee
Conditions Haemorrhagic Rectocolitis
Enrollment 100 participants
Start Date 2024-10-09
Primary Completion 2027-04-09 (estimated)
Study Completion 2027-04-09 (estimated)
Updated on ClinicalTrials.gov 2025-08-01