Can a VR headset turn a painful scope into a calmer experience?

NCT ID NCT06632691

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

100 people

The number who actually took part.

Started

Oct 2024

Finished

Aug 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Centre Hospitalier Departemental Vendee

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Universitaire Nantes

    Nantes, 44000, France

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