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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged 18 or over with UC in the active phase or in remission of their disease

• Patient who has already undergone rectosigmoidoscopy without general anaesthetic

• Patient requiring rectosigmoidoscopy (with colonoscope and air insufflation) as part of routine care

• Patient able to follow the Clinical Investigation protocol and having given written informed consent to participate

• Patient affiliated to the social security system or entitled beneficiary

Locations
Other Locations
France
Centre Hospitalier Departemental Vendee
RECRUITING
La Roche-sur-yon
Centre Hospitalier Universitaire Nantes
RECRUITING
Nantes
Contact Information
Primary
Clémentin GABORIAU
clementin.gaboriau@ght85.fr
0251446572
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2027-04-09
Participants
Target number of participants: 100
Treatments
Experimental: Rectosigmoidoscopy with virtual reality headset
No_intervention: Rectosigmoidoscopy without a virtual reality headset
Sponsors
Leads: Centre Hospitalier Departemental Vendee

This content was sourced from clinicaltrials.gov