NCT06632691Completed
Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis: a Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 7 Oct 2024
- Start date
- 9 Oct 2024
- Primary completion date
- 24 Aug 2026
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Diseases
- Ulcerative colitis
- NCT number
- NCT06632691
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 9 Oct 2024 to the primary completion date, 24 Aug 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with Crohn disease or indeterminate colitis
- 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.
Other
- Patients hospitalised with severe acute colitis, as defined by the truelove criteria.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Départemental Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Centre Hospitalier Universitaire Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.