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Stuffed animal that breathes slashes Kids' pain and tears during needle sticks

NCT ID NCT07430514

Symptom relief Sponsor: Koç University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a realistic breathing toy (a plush dog that moves and sounds like it's breathing) to distract children aged 1-3 during blood draws. Eighty kids were split into two groups: one used the toy, the other got standard care. Results showed the toy group had 51% less pain, 72% less crying, and lower heart rates, plus parents felt less anxious. No side effects occurred, making this a simple, safe way to ease needle pain.

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

80 people

The number who actually took part.

Started

Dec 2018

Finished

May 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

1 year to 3 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Parent or legal guardian provided written informed consent * Child aged 1-3 years * No blood sampling within the previous 6 months * Healthy children presenting for routine blood tests * No analgesic medication within 4 hours prior to the procedure * Child did not display fear of the breathing toy during initial introduction * Child had intact sensory and neurological function Exclusion Criteria: * Chronic illness requiring regular blood sampling * Known developmental delay or cognitive impairment * Previous syncopal episode during blood collection * Visual impairment * Inability to obtain blood sample on first venipuncture attempt * Current acute illness requiring hospitalization * Use of sedatives or anxiolytics within 24 hours prior to procedure * Parents unable to provide informed consent in Turkish language * Participation in another clinical trial within 30 days

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain, Procedural

As listed by the trial registrant

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

Acute pain Pediatric pain Procedural pain

Contacts and locations

Locations

  • Zeynep Kamil Maternity and Children's Disease Training and Research Hospital

    Istanbul, Istanbul, 34668, Turkey (Türkiye)

More trials for these conditions

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