RecruitingNot ApplicableNCT06632691

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


Sponsor

Centre Hospitalier Departemental Vendee

Enrollment

100 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a virtual reality (VR) headset during a bowel scope examination (called a rectosigmoidoscopy) can make the procedure more comfortable for people with ulcerative colitis. This type of scope examines the lower part of the colon and can be uncomfortable — the study wants to see if VR distraction helps reduce that discomfort. **You may be eligible if...** - You are 18 or older and have been diagnosed with ulcerative colitis - You have had a rectosigmoidoscopy before (without general anesthesia) - You need this procedure as part of your routine care - You are able to give written consent and follow the study protocol **You may NOT be eligible if...** - You have Crohn's disease or an uncertain type of inflammatory bowel disease - You are currently hospitalized for severe active colitis - You have had colorectal surgery or currently have a stoma (bowel diversion) - You have epilepsy, serious psychiatric illness, or vision/hearing problems that prevent VR use - You are pregnant or breastfeeding - You are participating in another clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEVirtual reality headset

Use of a virtual reality headset during rectosigmoidoscopy


Locations(2)

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, France

Centre Hospitalier Universitaire Nantes

Nantes, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06632691