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

NCT06632691 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

  • Haemorrhagic Rectocolitis

Interventions

DEVICE

Virtual reality headset

Use of a virtual reality headset during rectosigmoidoscopy

Sponsors & Collaborators

  • Centre Hospitalier Departemental Vendee

    lead OTHER

Principal Investigators

  • Morgane AMIL · Centre Hospitalier Départemental Vendée

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2027-04-09
Completion
2027-04-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06632691 on ClinicalTrials.gov