Cure My Disease

Don't miss your cure!

 Log in / Sign up

Simple devices could take the ouch out of newborn blood tests

NCT ID NCT07686627

Symptom relief Sponsor: Marmara University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests whether a ShotBlocker device or a warm gel pack can reduce pain and improve comfort in healthy newborns during routine heel prick blood tests. Babies are randomly assigned to receive one of these two non-drug treatments or standard care. Researchers measure pain scores, comfort levels, and vital signs like heart rate and oxygen levels before and after the procedure.

What this could mean

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

Active substance
ShotBlocker (device) and warm gel pack (device)
What this could lead to
If effective, these simple, drug-free tools could make routine newborn blood tests less painful and more comfortable for babies.
What could go wrong
This is a small, single-site study, so results may not apply to all newborns. The devices may not significantly reduce pain compared to standard care.

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

147 people

The number who actually took part.

Started

Oct 2025

Finished

May 2026

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

0 days to 1 month

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: * Gestational age ≥38 weeks * Healthy newborn * Scheduled for routine heel prick testing as part of the newborn screening program * 1-minute APGAR score ≥7 * No acute illness causing pain * No invasive procedures other than Hepatitis B vaccination after birth Exclusion Criteria: * Mother does not speak Turkish * Parent unwilling to participate * Multiple pregnancy * Maternal or fetal complications during delivery * Known or suspected genetic or metabolic disorder in the mother or infant

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heel prick are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

agnosia Pain, Procedural

As listed by the trial registrant

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

Heel prick Newborn Procedural pain

Contacts and locations

Locations

  • Kocaeli City Hospital

    Kocaeli, İzmit, 41060, Turkey (Türkiye)

More trials for these conditions

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