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Идёт набор NCT07543029

Kangaroo Care: Breastfeeding Success and Maternal Role

Без фазы С лечением Breastfeeding Maternal Role Postpartum Care Kangaroo Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Kangaroo Mother Care.
Кому может быть актуально
Состояния в реестре: Breastfeeding, Maternal Role, Postpartum Care, Kangaroo Care. Базовые параметры: 18 лет — 49 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Intermittent Kangaroo Care in the Early Postpartum Period to Primiparous Mothers on Breastfeeding Success and Perception of the Maternal Role

Обзор

Purpose: This is a randomized controlled trial designed to investigate the effects of Intermittent Kangaroo Mother Care (KMC) 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=0.548), a total of 108 mothers 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 intermittent 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).

Подробное описание

Intervention Protocol:

Experimental Group: In addition to routine delivery care, newborns will receive Kangaroo Mother Care (KMC). The newborn, wearing only a diaper and a hat, will be placed in an upright "chest-to-chest" position on the mother's bare chest. The infant's head will be maintained in a neutral physiological position, and the back will be covered with a blanket. The first application was performed under the researcher's supervision to ensure that the mothers were performing kangaroo care correctly. Mothers were provided with kangaroo care for 60 minutes (WHO, 2025b) after each feeding during the first 24 hours after birth. Mothers performed their first kangaroo care session with the researcher's assistance and subsequent sessions under the researcher's supervision. Mothers breastfed their babies every 2-3 hours and then provided kangaroo care.

Control Group: Participants will receive the standard hospital protocol (routine skin-to-skin contact immediately after birth and standard neonatal care). No additional KMC intervention will be applied by the study team.

Data Collection and Measurement Points:Data collection will be conducted at two specific time points to evaluate the effectiveness of the intervention:Baseline (0 Hour): Immediately following the first breastfeeding attempt (within the first hour postpartum), the LATCH Breastfeeding Assessment Tool and Semantic Differansial Scale will be administered to both groups to establish baseline breastfeeding success and mathernal role.Post-Intervention (24th Hour): At the end of the 24th hour postpartum, the LATCH tool will be re-administered to evaluate the change in breastfeeding success. Additionally, the Semantic Differential Scale-Myself as a Mother will be administered at this time point to compare maternal role perception between the two groups.

Statistical Analysis: The normality of the data will be assessed using the Skewness and Kurtosis coefficients. For Breastfeeding Success: A Two-Way Mixed ANOVA will be used to analyze the interaction between "Group" (Experimental vs. Control) and "Time" (0 vs. 24 hours).For Maternal Role Perception: Since this variable is measured only at the 24th hour, an Independent Samples t-test (or Mann-Whitney U test, depending on normality) will be used for inter-group comparison.All analyses will be performed using SPSS 25.0 with a significance level of p \< 0.05.

Вмешательства

  • Поведенческое Kangaroo Mother Care
    Newborns will be placed in an upright chest-to-chest position on the mother's bare chest. This intermittent skin-to-skin contact will be applied in sessions according to the mother's and newborn's stability and comfort, and will be maintained at regular intervals throughout the first 24 hours postpartum.

Первичные конечные точки

  • LATCH Breastfeeding Assessment Tool [Срок оценки: 8 month]
  • Semantic Difference Scale - Self-Assessment as a Mother [Срок оценки: 8 month]

Критерии участия

Критерии включения

  • 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 breastfeeding,
  • 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.).

Критерии исключения

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bucak State Hospital — Rize

Идентификаторы

NCT: NCT07543029 · GA-E-40465587-050.01.04-1502

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗