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Набор скоро начнётся NCT07295639

Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction

Без фазы С лечением Breastfeeding Attitudes Breast Feeding Paternal Behavior Health Education

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: Mobile-based application.
Кому может быть актуально
Состояния в реестре: Breastfeeding Attitudes, Breast Feeding, Paternal Behavior, Health Education. Базовые параметры: 19 лет — 65 лет · Мужчины.
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 →

Обзор

The aim of this interventional clinical trial is to assess whether a mobile-based antenatal education programme for expectant fathers has a positive effect on father-infant bonding, stress levels, and breastfeeding attitudes. The study aims to answer the following main questions: Does participation in a mobile-based prenatal education programme strengthen fathers' emotional bonds with their babies? Does the education reduce fathers' stress levels during the prenatal and postnatal periods? Does it increase the father's knowledge and supportive attitude towards breastfeeding? Researchers will compare whether there are measurable differences in attachment, stress, and breastfeeding attitudes between the intervention group (fathers receiving mobile-based education) and the control group (fathers receiving standard routine information). Participants: Will complete pre- and post-intervention questionnaires assessing attachment, stress, and breastfeeding attitudes. The intervention group will have access to a six-module mobile application covering topics such as infant care, nutrition, sleep routines, health and safety, emotional development, and daily care practices. The study will be conducted with fathers aged 19-65 who became fathers within the last month and voluntarily agreed to participate.

Подробное описание

This interventional clinical trial aims to evaluate the effectiveness of a mobile-based prenatal education programme designed specifically for expectant fathers. The programme aims to strengthen father-infant bonding, reduce paternal stress levels during the prenatal and early postnatal periods, and enhance fathers' knowledge and supportive attitudes related to breastfeeding.

The study is grounded in the increasing scientific evidence demonstrating that fathers play an important role in maternal-infant health, emotional bonding, family cohesion, and early childhood development. Despite this, fathers frequently receive limited antenatal education and often feel unprepared for infant care, breastfeeding support, and the psychological transition to fatherhood. Mobile health (mHealth) technologies provide accessible, cost-effective, and father-friendly educational opportunities that help reduce participation barriers.

In this trial, participants will be randomly assigned to either an intervention group or a control group. Fathers in the intervention group will have access to a six-module mobile application that offers structured prenatal education. The modules cover infant care, nutrition and feeding, sleep routines, health and safety practices, emotional and social development, and daily care skills. The educational content is designed to support cognitive, emotional, and behavioural readiness for fatherhood and to enhance fathers' confidence in newborn care.

Participants in both groups will complete pre- and post-intervention questionnaires assessing father-infant bonding, stress levels, and breastfeeding attitudes. The intervention group will complete the post-test after engaging with the mobile application, while the control group will receive routine standard information and complete the same assessments during the same time periods. Differences between the two groups will be analysed to determine whether the mobile-based education leads to significant improvements in psychological and behavioural outcomes.

The study will be conducted with fathers aged 19-65 who have become fathers within the past month and who voluntarily agree to participate. Exclusion criteria include lack of smartphone access, inability to use mobile applications, or unwillingness to complete the questionnaires.

This trial is expected to contribute to the development of evidence-based perinatal care interventions that enhance paternal involvement within the domain of women's health nursing, support family-centred care models, and promote practices that strengthen maternal and infant health.

Вмешательства

  • Поведенческое Mobile-based application
    The intervention is a six-module mobile-based training programme developed specifically for expectant fathers. The modules cover baby care, nutrition, sleep patterns, health and safety, emotional development and daily care. The aim is to strengthen the father-baby bond, reduce stress levels and develop a positive attitude towards breastfeeding.

Первичные конечные точки

  • Change in Paternal Stress Levels [Срок оценки: Baseline (Day 1) and Post-Intervention (8 weeks after baseline)]
  • Change in Father-Infant Bonding [Срок оценки: Baseline (Day 1) and Post-Intervention (8 weeks after baseline)]
  • Change in Breastfeeding Attitudes and Participation [Срок оценки: Baseline (Day 1) and Post-Intervention (8 weeks after baseline)]
  • Change in Marital Satisfaction Levels [Срок оценки: Baseline (Day 1) and Post-Intervention (8 weeks after baseline)]

Критерии участия

Критерии включения

  • Age between 19 and 65 years
  • First-time father
  • Has become a father within the last month
  • Has a healthy newborn without congenital anomalies or chronic illnesses
  • Does not have a premature or low-birth-weight baby
  • Has not become a father through adoption
  • Owns a mobile phone capable of accessing the mobile-based application
  • Has an Android or iOS operating system
  • Has not received any infant care training within the last 6 months
  • Has no physical or mental disability that would prevent viewing, hearing, or understanding the research questions or educational content
  • Voluntarily agrees to participate in the research

Критерии исключения

  • Declines to participate in the research
  • Does not own a smartphone
  • Cannot use mobile applications
  • Has a physical or mental condition that prevents completing the questionnaires
  • Has a baby with congenital anomalies or chronic medical conditions
  • Has a premature or low-birth-weight baby
  • Has received infant care training within the last 6 months
  • Has adopted a child
  • Is outside the 19-65 age range

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
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Gaziantep Islam Science and Technology University — Şahinbey

Публикации

  • Bakker CJ, Wyatt TH, Breth MC, Gao G, Janeway LM, Lee MA, Martin CL, Tiase VL. Nurses' Roles in mHealth App Development: Scoping Review. JMIR Nurs. 2023 Oct 17;6:e46058. doi: 10.2196/46058. PMID 37847533
  • Bich TH, Long TK, Hoa DP. Community-based father education intervention on breastfeeding practice-Results of a quasi-experimental study. Matern Child Nutr. 2019 Jan;15 Suppl 1(Suppl 1):e12705. doi: 10.1111/mcn.12705. PMID 30748110
  • Challacombe FL, Pietikainen JT, Kiviruusu O, Saarenpaa-Heikkila O, Paunio T, Paavonen EJ. Paternal perinatal stress is associated with children's emotional problems at 2 years. J Child Psychol Psychiatry. 2023 Feb;64(2):277-288. doi: 10.1111/jcpp.13695. Epub 2022 Oct 10. PMID 36215991

Идентификаторы

NCT: NCT07295639 · Ethical Approval: 582.45.13

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗