RecruitingNot Applicable

The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy

Turkey (Türkiye)45 participantsStarted 2026-06-01

Plain-language summary

This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy. Specifically, the research investigates the impact of mother-administered versus nurse-administered kangaroo care on pain levels during mandatory heel-stick blood sampling. The study seeks to determine which provider model is more effective in reducing procedural pain for these vulnerable newborns, thereby optimizing comfort and care protocols during phototherapy treatment.

Who can participate

Age range

2 Days – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hearth rate

Timeframe: 30 minutes

respiratory rate

Timeframe: 30 minutes

O2 saturation

Timeframe: 30 minutes

body temperature

Timeframe: 30 minutes

duration of crying

Timeframe: 30 minutes

Neonatal Infant Pain Scale

Timeframe: 30 minutes

Trial details

NCT IDNCT07761689

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Ebru UYGUR, MSc

05336822564 ebruygurr@gmail.com

View on ClinicalTrials.gov More Procedural Pain trials

Plain-language summary

Who can participate

Age range

2 Days – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.