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Storytime before surgery: could a toy ease Kids' fears?

NCT ID NCT03740841

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This pilot study looked at whether an interactive storyteller called LUNII could lower anxiety in children aged 4 to 6 with cleft lip and palate before their bone graft surgery. The goal was to see if using the device before the operation would also reduce pain and shorten hospital stays. The study was terminated early and included only 15 participants, so results are limited.

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

15 people

The number who actually took part.

Started

Jan 2019

Finished

Jan 2019

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

4 to 6 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 aged 4 to 6 years. * Alveolar bone graft with iliac crest donor site in children with unilateral or bilateral cleft lip and palate * Primary alveolar bone graft or first side when bilateral cleft * Followed at Necker since birth and operated according to the protocol used in the department. * Consent signed by the holder (or holders) of parental authority Exclusion Criteria: * Medical care different from the usual protocol applied in the service (secondary surgery, age \> 7 years) * Known psychomotor delay, associated rare syndrome or disease, known psychiatric disorders, other surgical procedures between hard palate closure and alveolar bone graft * Possession and/or prior use of LUNII by the child

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip/palate

As listed by the trial registrant

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

Cleft lip and palate

Contacts and locations

Locations

  • Hôpital Necker-Enfants Malades

    Paris, 75015, France

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Other studies related to the condition(s) this trial covers.