Using virtual reality to improve comfort during rectosigmoidoscopy for ulcerative colitis patients

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

This study is testing whether virtual reality headsets can help people with ulcerative colitis feel more comfortable during a rectosigmoidoscopy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Departemental Vendee (Academic / other)
• Locations: 2 sites (La Roche-sur-Yon and 1 other locations)
• Trial ID: NCT06632691 on ClinicalTrials.gov

What this trial studies

This project investigates the use of virtual reality headsets to enhance the comfort and acceptability of rectosigmoidoscopy in patients with ulcerative colitis. The study aims to address the low acceptability of this procedure, which is often associated with pain, bloating, and embarrassment. By employing medical hypnosis techniques through virtual reality, the researchers hope to improve patient tolerance during this necessary diagnostic examination. Participants will be monitored for their experiences and outcomes during the procedure.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and over with active or remissive ulcerative colitis who require rectosigmoidoscopy.

Not a fit: Patients with Crohn's disease, severe acute colitis, or contraindications to virtual reality use may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the comfort and willingness of patients to undergo necessary endoscopic evaluations.

How similar studies have performed: While the use of virtual reality in medical settings is gaining traction, this specific application for improving rectosigmoidoscopy comfort is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

La Roche-sur-Yon and 1 other locations

• Centre Hospitalier Departemental Vendee — La Roche-sur-Yon, France (Recruiting)
• Centre Hospitalier Universitaire Nantes — Nantes, France (Recruiting)

Study contacts

• Principal investigator: Morgane AMIL — Centre Hospitalier Départemental Vendée
• Study coordinator: Clémentin GABORIAU

Conditions Haemorrhagic Rectocolitis; Haemorrhagic rectocolitis