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CompletedNCT06632691VIRTUUpdated Aug 25, 2026

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

An interventional study of Virtual reality headset in Haemorrhagic Rectocolitis, sponsored by Centre Hospitalier Departemental Vendee. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

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. Assessment of mucosal healing is one of the therapeutic objectives defined in the STRIDE II consensus, and requires regular repeat endoscopic examinations in these patients.

The aim of the ACCEPT study, which involved administering a questionnaire to 916 patients with chronic inflammatory bowel disease, was to assess patients; acceptability and perceived usefulness of examinations designed to assess the activity of chronic inflammatory bowel disease. This 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%).

The dominant approaches to addressing this issue focus on replacing rectosigmoidoscopy with less invasive tools such as ultrasound and faecal calprotectin. However, rectosigmoidoscopy is still unavoidable, particularly for rectal forms (poor performance of ultrasound, low reliability of faecal calprotectin).

Virtual reality headsets are now part of our everyday lives. Developed as part of the neurosciences, they have applications in healthcare (pain care, dementia, post-traumatic stress disorder, etc.), occupational risk prevention and leisure (escape games, video games).

This device 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.

This approach has been evaluated in endoscopy, to improve the tolerance of colorectal cancer screening colonoscopies. A Chinese study (Liu et al, Clinical medicine 2022), which included 120 patients in a randomised trial comparing the virtual reality headset with a headset that was switched off, showed that the headset that was switched on made it possible to gain a median of 2 points on the pain scale, to reduce skin conductance (an indirect marker of nervousness) and to improve patient satisfaction. We hypothesise that the gain in SR would be the same, with an examination that is reputed to be less painful than colonoscopy without anaesthetic.

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.

02

Conditions studied

  • Haemorrhagic Rectocolitis

Keywords

  • Haemorrhagic rectocolitis
03

In context

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Rectosigmoidoscopy with virtual reality headset

    Device: Virtual reality headset

  • No intervention
    Rectosigmoidoscopy without a virtual reality headset

Interventions

  • DeviceVirtual reality headset

    Use of a virtual reality headset during rectosigmoidoscopy

06

What researchers measure

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.

07

Study locations

2 sites
  • Centre Hospitalier Departemental Vendee
    La Roche-sur-Yon, 85925, France
  • Centre Hospitalier Universitaire Nantes
    Nantes, 44000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06632691
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Oct 9, 2024
Start date
Oct 9, 2024
Primary completion
Aug 24, 2026
Completion
Aug 24, 2026
Last update
Aug 25, 2026

Study contacts

Morgane AMIL
principal investigator · Centre Hospitalier Départemental Vendée

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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