- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07496307
Структурированное обучение грудному вскармливанию у младенцев с отказом от груди
Влияние структурированного обучения грудному вскармливанию на сосательную функцию, мотивацию к грудному вскармливанию и привязанность матери и ребенка у младенцев с отказом от груди: рандомизированное контролируемое исследование
This randomized controlled trial aims to examine the effects of structured breastfeeding education supported by midwives on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. The study will be conducted with mothers who have infants aged 1-4 months and have been experiencing nipple refusal for at least 3 days and up to 30 days. Participants will be randomly assigned to either the intervention or control group; the intervention group will receive a one-week structured breastfeeding education program, while the control group will receive standard care. Following the education, online support will be provided for 15 days, and breastfeeding observations will be monitored. Sucking skills of the infants, mother-infant bonding, and maternal breastfeeding motivation will be assessed at both baseline and post-intervention evaluations.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This study will be conducted as a randomized controlled trial to determine the effects of structured breastfeeding education on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. Participants will include mothers with infants aged 1-4 months who have experienced nipple refusal for 3 to 30 days. Written informed consent will be obtained from all participating mothers, and they will be randomly assigned to either the intervention or control group.
Mothers in the intervention group will receive structured breastfeeding education through individual or group sessions lasting one hour per day for one week. The education will cover topics such as nipple refusal, benefits of breast milk, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, the importance of mother-infant bonding, and motivation-enhancing strategies. Following the education, participants will receive online support for 15 days, and breastfeeding progress will be monitored through daily observation forms.
The control group will receive only standard medical care, and an educational brochure will be provided after the study is completed. At baseline, mothers' demographic and obstetric information, infants' sucking skills, mother-infant bonding, and maternal breastfeeding motivation will be assessed. At the end of the education and follow-up period, a post-intervention evaluation will be conducted on day 16 using the same measurements, and the results will be compared.
This study aims to determine whether structured breastfeeding education improves the sucking skills of infants experiencing nipple refusal, strengthens mother-infant bonding, and positively influences maternal breastfeeding motivation.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Kars
-
Kars, Kars, Турция (Туркие), 36100
- Kafkas University Training and Research Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Inclusion Criteria (Dahil Etme Kriterleri):
Mothers with infants aged 1-4 months
Mothers of infants who have experienced nipple refusal for 3-30 days
Mothers who provide written informed consent
Mothers without pregnancy or postpartum complications
Mothers who are literate and able to understand the study questionnaires
Exclusion Criteria:
- Infants with serious congenital anomalies or health problems
Mothers with severe psychiatric or chronic illnesses
Any medical condition in the mother or infant that prevents participation
Mothers who refuse to complete the study or cannot comply with the follow-up
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Structured Breastfeeding Education
Mothers in this group will receive a one-week structured breastfeeding education program with midwife support. The education includes guidance on nipple refusal, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, importance of mother-infant bonding, and strategies to enhance maternal breastfeeding motivation. Following the program, participants will receive daily online support for 15 days, and breastfeeding progress will be monitored through daily observation forms. |
One-week, midwife-supported structured breastfeeding education for mothers of infants experiencing nipple refusal. Includes guidance on breastfeeding techniques, nipple refusal management, milk production enhancement, skin-to-skin contact, mother-infant bonding, and motivation strategies. Followed by 15 days of online support and daily breastfeeding monitoring. |
|
Без вмешательства: Routine Postpartum Care
Mothers in the control group will receive routine medical care and standard postnatal guidance provided by the hospital. No structured breastfeeding education or additional intervention will be provided during the study period. After completion of the study, participants will be given educational materials (brochure). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Breastfeeding Motivation Scale (for Primiparous Mothers)
Временное ограничение: From the start of the intervention to 16 days
|
Breastfeeding motivation will be assessed using the Breastfeeding Motivation Scale (BMS), developed by Peleg et al. (2015) and adapted into Turkish by Mızrak (2017). The scale consists of 23 items rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). The scale does not yield a total score; instead, subscale scores are calculated as the mean of the items. Higher scores indicate higher motivation in the respective subscale. |
From the start of the intervention to 16 days
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Maternal Attachment (Measured by Maternal Attachment Scale)
Временное ограничение: 16 days after the start of the intervention.
|
Maternal attachment will be assessed using the Maternal Attachment Scale (Maternal Bağlanma Ölçeği, MBÖ) developed by Muller (1994) and adapted into Turkish by Kavlak and Şirin (2009). The scale consists of 26 items rated on a 4-point Likert scale (1 = never, 4 = always). Total scores range from 26 to 104. Higher scores indicate higher maternal attachment. |
16 days after the start of the intervention.
|
Соавторы и исследователи
Следователи
- Главный следователь: Emel Güçlü Cihan, Assistant Professor, Kafkas University Training and Research Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MR-EM-8182-74
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data from this study will not be shared publicly due to privacy and confidentiality concerns. Data include sensitive information about mothers and their infants, and sharing identifiable data could compromise participant privacy. Aggregate study results will be shared in publications and reports.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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