Warm foot bath or gadgets? study tests best way to soothe baby pain

NCT ID NCT07348731

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

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a warm foot bath, a ShotBlocker device, or a Buzzy device can help reduce pain and stabilize vital signs in newborns during a heel lance (a routine blood test). Researchers will measure heart rate, breathing, oxygen levels, and pain scores in 90 full-term infants before, during, and after the procedure. The goal is to find a safe, non-drug method to improve newborn comfort.

What this could mean

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

Active substance: Foot bath, ShotBlocker, and Buzzy devices
What this could lead to: If one method works best, it could give hospitals a simple, drug-free way to reduce pain and stress in newborns during routine blood tests.
What could go wrong: This is a small, early-stage study (90 infants) comparing comfort methods, not a cure or treatment. Results may not apply to all newborns or settings.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jun 2026

An estimate. End dates often move.

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 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: * Newborns with a gestational age of ≥37 weeks * Newborns in the neonatal period (0-28 days) * Stable vital signs * Obtained informed consent from the parents * No use of analgesics or sedatives within the 24 hours before the procedure * Absence of any respiratory problems * First-time heel lance procedure * No condition that would interfere with pain assessment Exclusion Criteria: * Preterm or low birth weight infants (\< 2500 g) * Infants with congenital anomalies or requiring respiratory support * Infants receiving sedative or analgesic treatment

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As listed by the trial registrant

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

Heel lance procedures

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

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Warm foot bath or gadgets? study tests best way to soothe baby pain

What the study statuses mean