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Buzzy and coolsense take the ouch out of insulin shots for kids

NCT ID NCT06369649

Symptom relief Sponsor: Ankara Yildirim Beyazıt University Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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
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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This status has not been confirmed recently, so it may be out of date.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 two devices—Coolsense (cold) and Buzzy (cold + vibration)—to see if they could reduce pain and fear in children aged 6-12 during insulin injections. 90 kids with type 1 diabetes were split into three groups: one used Coolsense, one used Buzzy, and one received standard care. The goal was to make daily injections more comfortable for young patients.

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

90 people

The number who actually took part.

Started

Jul 2023

Finished

Mar 2024

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 10 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: * Being an inpatient in the Pediatric Endocrinology Service * Having a diagnosis of Type 1 Diabetes Mellitus (no more than 6 months have passed since the diagnosis) receiving insulin therapy * Being in the 6-10 age group. * Having no pain before the application (getting 0 points on the pain scale). * Blood sugar level above 80 mg/dl * Having parental permission * The child's willingness to participate in the research * Not having used any medication that would have an analgesic effect in the last 24 hours before application. * The child does not have a mental or neurological disability * Not having any disease that causes sensitivity to cold, such as Reynaud's syndrome or sickle cell anemia. * The child must be conscious and have no communication problems * The child and the parent must be able to speak Turkish Exclusion Criteria: * Being younger than 6 years old and older than 12 years old * Not having a diagnosis of Type 1 Diabetes * Presence of pain before application * Blood glucose level should be below 80 mg/dl before application * The person or the parent does not agree to participate in the research. * Having a disease that causes chronic pain * Presence of any incision or scar tissue in the area to be injected

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Conditions

The condition(s) this trial relates to.

Iatrophobia Pain type 1 diabetes mellitus

As listed by the trial registrant

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

Injection fear Injection site coldness Nurse's role Pain Pediatric disease Type 1 diabetes mellitus

Contacts and locations

Locations

  • Ankara City Hospital

    Çankaya, Ankara, Turkey (Türkiye)

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