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Tablets beat pills: study tests games over drugs for anxious kids

NCT ID NCT02192710

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared using an electronic tablet with age-appropriate games versus the sedative midazolam to reduce anxiety in children before outpatient surgery. 118 children aged 4 to 10 were randomly assigned to either play on a tablet or take midazolam. Researchers measured anxiety levels at key moments, like when separating from parents and during anesthesia mask induction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
midazolam (Hypnovel®)
What this could lead to
If successful, this could offer a non-drug way to calm children before surgery, avoiding side effects of medication.
What could go wrong
This is a small, single-center study with only 118 children, so results may not apply to all hospitals or surgeries. The tablet's effect may vary by child.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

118 people

The number who actually took part.

Start date

May 2013

Finished

Apr 2014

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 10 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: * Girls and boys aged 4 to 10 years, * American Society of Anesthesiologists Score between 1 and 3, * programmed outpatient surgery for a short term and low level of pain * Infection with influenza A virus confirmed with a quick diagnostic test, * informed consent from both parents Exclusion Criteria: * patients younger than 4 or older than 10 years old * preexisting psychiatric disorder with pedo-psychiatric follow-up * children with intellectual disability * psychotropic referred to anxiolytic and / or antipsychotic * history of surgery (n\>=3) * refusal to participate

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Service d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

    Bron, 69500, France