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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual reality headset

    Device

    Use of a virtual reality headset during rectosigmoidoscopy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Rectosigmoidoscopy with virtual reality headsetExperimental treatment 1 intervention
Group B: Rectosigmoidoscopy without a virtual reality headsetNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pain intensity measured on a visual analogue scale

Pain intensity measured on a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (maximum intolerable pain) immediately after the examination.

Time frame
Immediately after the examination.

Secondary outcomes

Other outcomes

Sponsors and contacts

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