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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Departemental Vendee

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Psychotic patients or patients diagnosed with psychiatric disorders

Trial design

Treatments tested in this trial

  • Virtual reality headset

Treatment groups

100 Participants
are divided into 2 treatment groups