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Robotic seal cuddles away Kids' IV needle fears

NCT ID NCT07299006

Symptom relief Sponsor: Fondation Lenval 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 6 times

Summary

This study tests whether a robotic baby seal named PARO can reduce pain and anxiety in children aged 1 to 7 during a common but stressful procedure: placing an IV line. About 120 children will either receive standard care alone or standard care plus the robot. Researchers will measure pain using a special scale and also look at distress, heart rate, and parent anxiety.

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

Mar 2026

Expected to finish

Mar 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

1 year to 7 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: 1. Age between 12 months and 7 years. 2. Requirement for peripheral intravenous catheterization (PIC). 3. Written informed consent obtained from at least one parent or legal guardian. 4. Affiliation with the national health insurance system (social security). Exclusion Criteria: 1. Requirement for contact isolation, including colonization or infection with multidrug-resistant organisms (MDROs). 2. Visual or hearing impairment. 3. Known psychiatric disorder. 4. Inability to understand French. 5. Life-threatening emergency requiring immediate intervention. 6. Need for strong analgesic medication (e.g., morphine, ketamine, or intranasal analgesics).

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Conditions

The condition(s) this trial relates to.

agnosia

As listed by the trial registrant

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

Pain management

How to take part

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

  1. The places running it

    5 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

  • CHU de NICE

    RECRUITING

    Nice, France

  • Centre Hospitalier Universitaire Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Centre hospitaliers de Grasse

    NOT_YET_RECRUITING

    Grasse, France

  • Chu Morvan

    NOT_YET_RECRUITING

    Brest, France

  • Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

    RECRUITING

    Nice, 06000, France

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