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Lullabies and white noise calm NICU babies without drugs, study finds

NCT ID NCT07590479

Symptom relief Sponsor: Başakşehir Çam & Sakura City Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compared the effects of white noise and a traditional Turkish lullaby on 70 full-term newborns in the neonatal intensive care unit (NICU). Each baby listened to one type of sound for 20 minutes, three times a day, for four days. Both sounds safely lowered heart rate while keeping breathing and oxygen levels stable, suggesting they can help calm infants without medication.

What this could mean

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

Active substance
white noise and lullaby (auditory stimulation)
What this could lead to
If confirmed, these simple sounds could become a standard, drug-free way to help calm newborns in intensive care.
What could go wrong
This is a small, completed study (70 infants) with no long-term follow-up. Results may not apply to preterm or sicker babies, and the calming effect may not be clinically significant.

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

70 people

The number who actually took part.

Started

Sep 2025

Finished

Dec 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 ≥ 37 completed weeks * Birth weight ≥ 2500 grams * Postnatal age between 0 and 28 days at enrollment * Admitted to the neonatal intensive care unit (NICU) for any medical reason * Spontaneous breathing (not intubated) * No current sedative or analgesic medication * Written informed consent obtained from parents or legal guardians Exclusion Criteria: * Gestational age \< 37 weeks (preterm infants) * Birth weight \< 2500 grams * Congenital hearing loss or major congenital anomaly * History of seizures or intracranial hemorrhage * Requirement for mechanical ventilation * Current use of sedative or analgesic drugs * Early discharge or death before completion of the intervention protocol * Parental refusal or withdrawal of consent during study procedures

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As listed by the trial registrant

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

Auditory Neonates Non-pharmacological interventions White noise

Contacts and locations

Locations

  • Basaksehir Cam and Sakura City Hospital

    Istanbul, Turkey (Türkiye)

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