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Virtual reality headsets tested to ease needle pain in young leukemia patients

NCT ID NCT06697275

Symptom relief Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a virtual reality headset can reduce pain and anxiety in children aged 6 to 16 with leukemia when they get a needle placed into a port. About 120 kids will be randomly assigned to use either a hypnotic VR, an interactive VR, or standard care (numbing cream and distraction). The goal is to see if repeated VR use over three months makes needle sticks less painful and less scary.

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 (hypnotic or interactive) via Deepsen® mask with Birdy® software
What this could lead to
If it works, this could offer a drug-free way to ease pain and fear during repeated needle procedures for children with leukemia.
What could go wrong
This is a relatively small, early-stage trial (120 participants) testing a device, not a drug. The effect may be small or not better than standard distraction techniques.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

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

6 to 16 years

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: * Children from 6 to 16 years old suffering from leukemia requiring needle insertion into an implantable port and having a life expectancy greater than or equal to 3 months * Subjects and their parents who have been informed of the study and having expressed their informed consent * Children without contraindications to the use of MEOPA® : * Patient requiring 100% oxygen ventilation * Intracranial hypertension * Any alteration in the state of consciousness preventing the patient\'s cooperation * Children without contraindication to the use of the virtual reality mask: * Epilepsy * Psychiatric illness * Children and parents able to use the self-assessment scales proposed in the study * Enrolment in the Social Security system Exclusion Criteria: Children from 6 to 16: * Having a modification of pain\'s integration (spina bifida for example) * Requiring contact isolation (conjunctivitis, contagious skin condition, etc.) * With a history of seizures

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Conditions

The condition(s) this trial relates to.

acute leukemia anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute leukemia Anxiety and fear Children and adolescents Virtual reality

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assistance Publique - Hôpitaux de Marseille

    RECRUITING

    Marseille, 13005, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • CHU de Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63000, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, 31059, France

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