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Идёт набор NCT07410949

Postpartum Acupressure Education and Breastfeeding Outcomes

Без фазы С лечением Breastfeeding Lactation Postpartum Period

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: Postpartum Acupressure Education Program.
Кому может быть актуально
Состояния в реестре: Breastfeeding, Lactation, Postpartum Period. Базовые параметры: 18 лет — 45 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
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Официальное название

Effect of Postpartum Acupressure Education on Breastfeeding Outcomes: A 12-Month Randomized Controlled Trial

Обзор

This randomized controlled trial evaluates whether acupressure education provided to mothers within the first 48 hours postpartum improves exclusive breastfeeding rates at 6 months compared with standard postpartum care alone. Mothers in the intervention group will receive structured education on self-administered acupressure at selected points and will be encouraged to continue home-based practice, while the control group will receive standard breastfeeding support. Participants will be followed for 12 months to assess breastfeeding continuation, breastfeeding self-efficacy, breastfeeding quality, and breastfeeding-related outcomes.

Подробное описание

Exclusive breastfeeding for the first 6 months and continued breastfeeding up to 12 months are strongly associated with improved maternal and infant health outcomes. Despite widespread implementation of Baby-Friendly Hospital Initiative practices, early postpartum challenges often compromise breastfeeding continuation. Scalable, low-cost, self-care-based interventions that enhance maternal confidence and perceived control may support sustained breastfeeding.

This study is a two-arm, parallel-group, randomized controlled trial designed to assess the effectiveness of postpartum acupressure education as an adjunct to standard breastfeeding care. Eligible mothers will be randomized in a 1:1 ratio to either an acupressure education plus standard care group or a standard care-only group. Acupressure education will include face-to-face instruction, printed visual materials, and a short instructional video, focusing on the acupoints CV17 (Shanzhong), ST18 (Rugen), SI1 (Shaoze), ST36 (Zusanli), and SP6 (Sanyinjiao).

The primary outcome is the rate of exclusive breastfeeding at 6 months postpartum, defined according to World Health Organization criteria. Secondary outcomes include any breastfeeding at 12 months, breastfeeding self-efficacy, breastfeeding quality, timing of complementary feeding introduction, breastfeeding-related adverse events, and maternal satisfaction. Analyses will be conducted using an intention-to-treat approach.

Вмешательства

  • Другое Postpartum Acupressure Education Program
    Structured education on self-administered acupressure provided within 48 hours postpartum, including face-to-face instruction, printed visual materials, and a short instructional video. Participants are instructed to apply acupressure at specified points twice daily at home according to the study protocol.

Первичные конечные точки

  • Exclusive breastfeeding rate at 6 months postpartum [Срок оценки: At 6 months postpartum]
Вторичные конечные точки (7)
  • Any breastfeeding rate at 12 months postpartum [Срок оценки: At 12 months postpartum]
  • Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) score [Срок оценки: Baseline (≤48 hours postpartum), 1, 3, 6, and 12 months postpartum]
  • Breastfeeding quality score (LATCH) [Срок оценки: Baseline (≤48 hours postpartum) and 1 month postpartum]
  • Maternal breastfeeding satisfaction score [Срок оценки: 1 month, 3 months, 6 months, and 12 months postpartum]
  • Time to introduction of complementary feeding [Срок оценки: From birth up to 12 months postpartum]
  • Bottle or pacifier use [Срок оценки: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months postpartum]
  • Breastfeeding-related adverse events [Срок оценки: From baseline through 12 months postpartum]

Критерии участия

Критерии включения

  • Age 18 to 45 years
  • Term singleton birth (≥37 weeks of gestation)
  • ≤48 hours postpartum at the time of enrollment
  • Intention to breastfeed
  • Ability to communicate in Turkish
  • Access to a smartphone for educational materials and follow-up reminders
  • Willingness to provide written informed consent

Критерии исключения

  • Contraindications to breastfeeding (e.g., infant galactosemia)
  • Severe neonatal condition preventing breastfeeding
  • Severe maternal medical or psychiatric condition interfering with breastfeeding
  • Current opioid, alcohol, or substance dependence
  • Multiple gestation pregnancy
  • Severe breast injury or condition within the first 72 hours postpartum preventing breastfeeding

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
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Niğde Ömer Halisdemir University Hospital — Niğde

Идентификаторы

NCT: NCT07410949 · 22504254-050.04-18

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗