RecruitingNot Applicable

Kangaroo Care: Breastfeeding Success and Maternal Role

Turkey (Türkiye)112 participantsStarted 2025-06-01

Plain-language summary

Purpose: This is a randomized controlled trial designed to investigate the effects of Kangaroo Mother Care (KMC) applied in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role. Methodology and Sample: Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026. Sample Size: Based on G\*Power analysis (alpha=0.05, power=80%, effect size d=0.566), a total of 112 mothers (56 intervention, 56 control) will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org. Intervention: Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported. Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support). Data Collection Tools: Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

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: * For mothers: * It must be the mother's first birth, * Birth must have been vaginal, * The mother must be healthy, * The mother must voluntarily participate in the study, * The mother must not have any communication-impairing conditions (language, cognitive problems, etc.), For babies: * Birth weight must be between 2500-4000 grams; * The newborn must be healthy, * Exclusively breastfed, * The newborn must be at term gestation (38-42 weeks), * The newborn's Apgar score at 1 and 5 minutes must be above 7, * The newborn must not have any health problems that could affect breastfeeding (cleft palate, cleft lip, esophageal atresia, etc.). Exclusion Criteria: \-

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

LATCH Breastfeeding Assessment Tool

Timeframe: 8 month

Semantic Difference Scale - Self-Assessment as a Mother

Timeframe: 8 month

Trial details

NCT IDNCT07543029

SponsorRecep Tayyip Erdogan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-11

Contact for this trial

Gamzegül ALTAY, Assistant Professor

+90 464 2141059 gamzegul.altay@erdogan.edu.tr

View on ClinicalTrials.gov More Breastfeeding trials