CompletedNot Applicable

The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort

Turkey (Türkiye)120 participantsStarted 2025-02-20

Plain-language summary

This research will be conducted using a randomized controlled, double-blind experimental design to determine the effects of breastfeeding and kangaroo care on the pain and comfort of newborn babies before heel prick blood sampling. The study group will consist of newborn babies, and one of the observers administering the pain and comfort scores will be independent of the research participants, with the observer evaluating the babies without knowing which group they belong to. Study Hypotheses H0a = Breastfeeding before heel prick test in newborns does not affect the baby's pain. H1a = Breastfeeding before heel prick test in newborns reduces the baby's pain. H0b = Kangaroo care before heel prick test in newborns does not affect the baby's pain. H1b = Kangaroo care before heel prick test in newborns reduces the baby's pain. H0c = Breastfeeding before heel prick test in newborns does not affect the baby's comfort level. H1c = Breastfeeding before heel prick test in newborns increases the baby's comfort level. H0d = Kangaroo care before heel prick test in newborns does not affect the baby's comfort level. H1d = Kangaroo care before heel prick test in newborns increases the baby's comfort level. The research is planned to be conducted at the Obstetrics and Gynecology Department of Sivas Cumhuriyet University Women's and Children's Hospital in Sivas city center between February 1, 2025 and March 1, 2026. The study population will consist of newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital. The study sample will comprise newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital who meet the study criteria. The study (breastfeeding group, kangaroo care group) and control groups will consist of a total of 120 newborns. The following instruments will be used to collect research data: Newborn and Parent Demographic Information Form, Neonatal Infant Pain Scale (NIPS), Neonatal Comfort Behavior Scale, informed consent form, and Blinded Evaluator NIPS form. The study will also utilize a pulse oximeter, a camera, and a stopwatch.

Who can participate

Age range

24 Hours – 1 Day

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: * 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

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

Determining the appropriate interval for breastfeeding and kangaroo care in newborns before heel prick blood sampling, as well as assessing pain and temperature.

Timeframe: about a year

Trial details

NCT IDNCT07580677

SponsorCumhuriyet University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

View on ClinicalTrials.gov More Comfort in Neonates trials