Lullaby or Mother's voice: a new weapon against newborn pain?

NCT ID NCT07773792

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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether listening to a mother's voice or music therapy can reduce pain and stress in newborns during heel prick blood tests. About 80 newborns will be randomly assigned to receive music, maternal voice, or standard care during the procedure. Researchers will measure pain using the Neonatal Infant Pain Scale and stress using a dedicated stress scale. If these simple, non-drug methods work, they could offer a gentle way to improve newborn comfort during routine procedures.

What this could mean

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

Active substance
Music therapy using the song 'The Happiest Child' and recorded maternal voice
What this could lead to
If effective, this could offer a simple, drug-free way to reduce pain and stress in newborns during routine heel prick tests, potentially improving their immediate comfort and long-term pain sensitivity.
What could go wrong
This is a small, early-stage trial, and the effect may be modest or not generalizable. The intervention's success depends on individual newborn responses, and it does not replace standard pain management.

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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 80 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

0 to 40 days

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 within the first 24-48 hours after birth or 7-14 days old * At least 2 hours after the last painful intervention * Children whose parents agreed to participate in the study were included. Exclusion Criteria: * Presence of hearing impairment * Absence of Parental Consent Form

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As listed by the trial registrant

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How to take part

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Contacts and locations

Locations

  • Bilecik Seyh Edebali University

    Bilecik, Turkey, 11230, Turkey (Türkiye)

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