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Mother's lullaby or kangaroo care: a gentle sleep aid for tiny patients?

NCT ID NCT07725094

Symptom relief Sponsor: Kirsehir Ahi Evran Universitesi 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 This study
Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
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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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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Status unknown
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First seen Jul 24, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This trial tests whether gentle sensory interventions from mothers — kangaroo care (skin-to-skin contact), lullabies, or soothing touch and voice — can help newborns in the neonatal intensive care unit fall asleep faster and sleep more deeply. Researchers will monitor sleep states, heart rate, and breathing in 80 stable newborns. The goal is to see if these simple, drug-free approaches can improve rest and stability for hospitalized infants.

What this could mean

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

Active substance
maternal sensory stimulation (kangaroo care, lullabies, tactile-auditory soothing)
What this could lead to
If effective, these simple, drug-free interventions could improve sleep quality and stability for newborns in intensive care, supporting their development.
What could go wrong
This is a small, early-stage trial. Results may not apply to all newborns, and the effects on long-term outcomes are unknown.

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 80 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

35 to 42 weeks

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 between 35 and 42 completed weeks. * Birth weight between 2,000 and 4,200 grams. * Clinically stable newborn admitted to the neonatal intensive care unit. * Spontaneous breathing without the need for mechanical ventilation. * Not receiving sedative medications. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Five-minute Apgar score \<4. * Requirement for advanced resuscitation after birth. * Presence of a major congenital anomaly. * Requirement for invasive intervention involving the head region. * Diagnosed central nervous system dysfunction or neurological disorder. * Presence of severe postnatal medical complications that may affect study outcomes. Exclusion Criteria (during the research): * The newborn develops an unexpected need for resuscitation during the study, as this may adversely affect the central nervous system and consequently influence sleep-wake patterns and study outcomes. * A parent or legal guardian withdraws consent for the newborn's participation in the study.

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As listed by the trial registrant

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

Hospitalized newborn Neonatal intensive care unit

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

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Contacts and locations

Locations

  • Kirsehir Ahi Evran Universty

    Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

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