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Skin-to-Skin comfort: can a Mother's touch soothe a Newborn's pain?

NCT ID NCT07761689

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether kangaroo care—holding a diaper-clad baby skin-to-skin on the chest—can reduce pain during a routine heel-prick blood test in newborns receiving phototherapy for jaundice. It compares two approaches: kangaroo care given by the mother versus by a nurse. The study measures pain through heart rate, breathing, oxygen levels, crying, and a standard pain scale to see which method is more comforting.

What this could mean

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

Active substance
Kangaroo care (skin-to-skin contact with mother or nurse)
What this could lead to
If effective, this could help standardize kangaroo care as a simple, drug-free way to ease pain during routine blood tests in newborns, potentially improving comfort and care protocols.
What could go wrong
This is a small early-stage trial, and results may not apply to all newborns. The effect on pain may be modest, and differences between mother and nurse care might not be 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

About 45 people

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

Started

Jun 2026

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

2 to 7 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: * Voluntary participation of the mother * Gestational age of 38 weeks or more * Diagnosis of physiological hyperbilirubinemia only * Serum bilirubin level within the moderate-high range (13-18 mg/dL) according to the Turkish Neonatal Society Guideline for the Management, Follow-up, and Treatment of Neonatal Jaundice (2022 update) * Postnatal age between 2 and 7 days * Absence of any condition preventing the infant from feeding * Absence of any maternal health condition that would preclude the application of kangaroo care * Ability of the mother to speak Turkish and to understand the information provided about the study Exclusion Criteria: * Gestational age less than 34 weeks or 38 weeks and above * Diagnosis of sepsis or any other systemic infection * Presence of congenital anomalies * Diagnosis of pathological jaundice * Use of antibiotic therapy * Serum bilirubin level greater than 18 mg/dL * Postnatal age greater than 7 days * Mother's refusal to participate in the study

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Conditions

The condition(s) this trial relates to.

hyperbilirubinemia Hyperbilirubinemia, Neonatal Pain, Procedural

As listed by the trial registrant

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

Neonatal hyperbilirubinemia Procedural pain

How to take part

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

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Başakşehir Çam and Sakura City Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

More trials for these conditions

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