Actively Recruiting
Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis: a Randomised Controlled Trial
Led by Centre Hospitalier Departemental Vendee · Updated on 2025-08-01
100
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis: a Randomised Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 or over with ulcerative colitis in active phase or remission
- Patients who have previously undergone rectosigmoidoscopy without general anaesthetic
- Patients requiring rectosigmoidoscopy with colonoscope and air insufflation as part of routine care
- Patients able to follow the clinical investigation protocol and who have given written informed consent
- Patients affiliated to the social security system or entitled beneficiaries
You will not qualify if you...
- Patients with Crohn disease or indeterminate colitis
- Patients hospitalized with severe acute colitis as defined by the Truelove criteria
- Patients with a stoma or history of colorectal resection
- Patients with contraindications to virtual reality headset use, including psychotic or psychiatric disorders, uncontrolled epilepsy, or visual/hearing impairments preventing headset use
- Patients participating in another clinical research protocol affecting study objectives
- Patients already randomized in this clinical investigation
- Pregnant, parturient, or breastfeeding patients
- Patients under guardianship, curatorship, deprived of liberty, or under activated protection mandates or family habilitation
- Patients under court protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, France, 85925
Actively Recruiting
2
Centre Hospitalier Universitaire Nantes
Nantes, France, 44000
Actively Recruiting
Research Team
C
Clémentin GABORIAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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