Can a VR headset turn a painful scope into a calmer experience?
NCT ID NCT06632691
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This trial tests whether using a virtual reality headset during a rectosigmoidoscopy (a type of colonoscopy) can reduce pain and anxiety in people with ulcerative colitis. Participants will be randomly assigned to receive standard care or to wear a VR headset that provides medical hypnosis, music, and breathing guidance during the procedure. The study measures pain levels right after the exam to see if VR improves tolerance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Virtual reality headset delivering medical hypnosis, music therapy, and cardiac coherence during rectosigmoidoscopy
- What this could lead to
- If effective, VR could become a drug-free way to ease discomfort and embarrassment during colonoscopies, improving patient experience and willingness to undergo needed monitoring.
- What could go wrong
- The trial is relatively small and early-stage, and results may not apply to all patients. VR might not reduce pain significantly, and some people may find the headset uncomfortable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, 85925, France
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Centre Hospitalier Universitaire Nantes
Nantes, 44000, France
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