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

NCT06632691 | Recruiting

• 1 other identifier: CHD23_0096
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Haemorrhagic rectocolitis

Outcome Measures

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.

  Immediately after the examination.

Study Arms (2)

Rectosigmoidoscopy with virtual reality headset

EXPERIMENTAL

Device: Virtual reality headset

Rectosigmoidoscopy without a virtual reality headset

NO INTERVENTION

Interventions

Virtual reality headset DEVICE

Use of a virtual reality headset during rectosigmoidoscopy

Rectosigmoidoscopy with virtual reality headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, 85925, France

RECRUITING

Centre Hospitalier Universitaire Nantes

Nantes, 44000, France

RECRUITING

Study Officials

• Morgane AMIL

  Centre Hospitalier Départemental Vendée

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clémentin GABORIAU

CONTACT

0251446572; clementin.gaboriau@ght85.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)