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Cuddle or feed before the prick: simple comforts may ease newborn pain

NCT ID NCT07580677

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study tested whether breastfeeding or kangaroo care (skin-to-skin holding) before a routine heel prick blood test can lower pain and increase comfort in healthy full-term newborns. Researchers randomly assigned 120 babies to one of three groups: breastfeeding, kangaroo care, or standard care. Pain and comfort were measured using validated scales by an observer who did not know which group each baby was in. The goal is to find gentle, non-drug ways to ease minor procedure-related discomfort in newborns.

What this could mean

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

Active substance
breastfeeding and kangaroo care
What this could lead to
If effective, these simple, drug-free methods could become standard practice to reduce pain and improve comfort in newborns during routine blood tests.
What could go wrong
This is a small, single-center study. Results may not apply to all newborns or settings, and the effect may be modest.

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

120 people

The number who actually took part.

Started

Feb 2025

Finished

Jan 2026

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

24 hours to 1 day

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: * Parental consent must be obtained in accordance with the participant information and consent form * The baby must be term, between 37-42 weeks gestation * Birth weight must be 2500 grams or more * The mother must be present with the baby * The baby must be healthy (no physical, metabolic, or genetic diseases, no surgical procedures have been performed) * There must be no condition that prevents pain assessment (neuromotor developmental delay, etc.) * The baby must not have undergone any invasive procedures other than routine interventions * The baby must have been born by cesarean section * The mother must speak and understand Turkish fluently Exclusion Criteria: * Pre-procedure NIPS score of 3 or higher * Lack of parental consent based on participant information and consent form * Newborn born before 37 weeks of gestation * Birth weight under 2500 grams * Unstable general condition * Vaginal delivery * Invasive procedures performed on the baby other than routine procedures * Failure to obtain heel prick blood on the first attempt * Mother not speaking Turkish

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

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

Breast feeding Comfort in neonates Kangaroo care Pain in newborns

Contacts and locations

Locations

  • Sivas Cumhuriyet Üniversitesi Sağlık Hizmetleri Uygulama ve Araştırma Hastanesinde Kadın Hastalıkları Obs-tetri servisi

    Sivas, Merkez, 58030, Turkey (Türkiye)

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