- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07705932
Investigation of the Effect of Video-Assisted Breastfeeding Education on State Anxiety, Breastfeeding Myths, and Breastfeeding Motivation in Primiparous Mothers
Investigation of the Effect of Video-Assisted Breastfeeding Education on State Anxiety, Breastfeeding Myths, and Breastfeeding Motivation in Primiparous Mothers: A Randomized Controlled Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Breastfeeding is recognized as the optimal method of infant feeding and provides substantial health benefits for both infants and mothers. The World Health Organization recommends initiation of breastfeeding within the first hour after birth, exclusive breastfeeding for the first six months, and continued breastfeeding with appropriate complementary feeding up to two years of age or beyond. Despite these recommendations, exclusive breastfeeding rates remain below desired levels worldwide.
Successful breastfeeding is influenced by multiple psychological, educational, and sociocultural factors. Primiparous mothers frequently experience uncertainty, anxiety, inadequate confidence, and misconceptions regarding breastfeeding. Breastfeeding myths, such as concerns about insufficient milk supply or beliefs that certain maternal characteristics determine breastfeeding success, may negatively affect breastfeeding practices and continuation. Maternal anxiety has also been associated with reduced breastfeeding confidence and motivation.
Advances in information and communication technologies have created new opportunities for delivering breastfeeding education. Video-assisted educational interventions provide standardized, visually supported, and repeatedly accessible learning materials that may improve knowledge acquisition, reinforce practical skills, and increase maternal confidence. However, evidence regarding the effectiveness of structured video-assisted breastfeeding education on breastfeeding motivation, breastfeeding myths, and maternal state anxiety among primiparous women remains limited.
This study is designed as a parallel-group randomized controlled trial conducted in Family Health Centers in Iğdır Province, Türkiye. Eligible primiparous pregnant women will be randomly allocated to either a video-assisted breastfeeding education group or a routine care group. The educational intervention consists of three expert-developed video modules covering breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths. Videos will be delivered weekly via WhatsApp during late pregnancy. Participants may view the videos as often as desired, and researchers will obtain feedback after each module through telephone or WhatsApp communication.
Women allocated to the control group will receive routine breastfeeding education provided within standard antenatal and postnatal healthcare services. Outcome assessments will be conducted before the intervention during pregnancy and again at eight weeks postpartum. The study aims to determine whether video-assisted breastfeeding education can improve breastfeeding-related psychological and behavioral outcomes compared with routine care alone.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Women aged 18 years or older.
- Primiparous pregnant women.
- Gestational age between 32 and 36 weeks.
- Planning to breastfeed after delivery.
- Singleton pregnancy.
- Able to read and write in Turkish.
- Using WhatsApp.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- High-risk pregnancy or serious obstetric complications.
- Newborns with serious congenital anomalies or medical conditions requiring treatment and separation from the mother (e.g., dysphagia).
- Mothers with severe nipple abnormalities that may prevent breastfeeding.
- Withdrawal of informed consent at any stage of the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Video-Assisted Breastfeeding Education
Participants assigned to the intervention group will receive a structured video-assisted breastfeeding education program in addition to routine antenatal and postnatal care.
The intervention consists of three educational video modules covering breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths.
Videos will be delivered weekly via WhatsApp during late pregnancy.
Participants may watch the videos as often as needed and will receive follow-up through telephone or WhatsApp after each module to address questions and obtain feedback.
Outcome assessments will be conducted at baseline during pregnancy and at 8 weeks postpartum.
|
Participants will receive a structured video-assisted breastfeeding education program in addition to routine antenatal and postnatal care.
The intervention consists of three educational video modules developed based on current evidence and expert opinion.
The modules cover breastfeeding fundamentals, breastfeeding motivation, and common breastfeeding myths.
Videos will be delivered weekly via WhatsApp during late pregnancy.
Participants will be able to watch the videos repeatedly at their convenience.
After each module, researchers will contact participants via telephone or WhatsApp to obtain feedback and answer questions.
|
|
Без вмешательства: Routine Care
Participants assigned to the control group will receive routine antenatal and postnatal care, including standard breastfeeding education provided by healthcare professionals.
No additional video-assisted educational intervention will be provided.
Outcome assessments will be conducted at baseline during pregnancy and at 8 weeks postpartum.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Breastfeeding Motivation
Временное ограничение: Baseline (32-36 weeks of pregnancy) and 8 weeks postpartum
|
Breastfeeding motivation will be assessed using the Breastfeeding Motivation Scale to evaluate the effect of the video-assisted breastfeeding education program among primiparous women.
The Breastfeeding Motivation Scale consists of 23 items and five subscales.
Each item is rated on a 4-point Likert scale (1-4).
The scale does not provide a total score; each subscale is evaluated separately.
Higher subscale scores indicate higher breastfeeding motivation in the corresponding dimension.
|
Baseline (32-36 weeks of pregnancy) and 8 weeks postpartum
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
- BilecikSeyhEU-KDH-GA-01
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.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .