Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis: a Randomised Controlled Trial
Recruiting · NCT06632691 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Departemental Vendee
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Patients with Crohn disease or indeterminate colitis
- Patients hospitalised with severe acute colitis, as defined by the truelove criteria.
- Patients with a stoma in place or with a history of colorectal resection.
- Patients with a contraindication to the use of the virtual reality headset:
- Psychotic patients or patients diagnosed with psychiatric disorders
- Patients with uncontrolled epilepsy
- Patients with visual problems (lack of binocular vision, blindness) and/or hearing problems (deafness) that prevent them from using virtual reality.
- Patients taking part in another clinical research protocol having an impact on the objectives of the clinical investigation
- Patients already randomized in the clinical investigation
- Pregnant, parturient or breast-feeding patients
- Patients under guardianship, curatorship or deprived of their liberty
- Patient under activated protection mandate or family habilitation
- Patients under court protection.
Where it is running
2 locations listed.
- Centre Hospitalier Departemental Vendee - La Roche-sur-Yon, France
- Centre Hospitalier Universitaire Nantes - Nantes, France