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Набор скоро начнётся NCT07370025

The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants

Без фазы С лечением Newborn Infant Bonding Self Efficacy Postpartum Depression (PPD)

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: Maternal Lullaby Singing.
Кому может быть актуально
Состояния в реестре: Newborn Infant, Bonding, Self Efficacy, Postpartum Depression (PPD). Базовые параметры: от 18 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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Обзор

This randomized, single-blind controlled trial aims to evaluate the effects of maternal lullaby singing during infant bathing on mother-infant bonding, postpartum depressive symptoms, and perceived parenting self-efficacy in mothers of healthy term infants. The postpartum period represents a critical phase for maternal psychological adjustment, during which stress, depressive symptoms, and low parenting confidence may negatively affect the quality of mother-infant interaction and bonding. Low-cost, culturally meaningful, and non-pharmacological interventions that support maternal well-being and early bonding are therefore of particular importance. The study will be conducted with mothers who have delivered healthy term infants in a public hospital. Eligible participants will be randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive a structured bathing education and will be instructed to bathe their infants three times per week for two consecutive weeks while singing a lullaby using their own voice in a calm and quiet home environment. Live-recorded music will not be used. The intervention emphasizes sensory interaction, emotional closeness, and maternal voice as key components. Each bathing session is expected to last approximately 10-15 minutes. The control group will receive routine postpartum care without a structured lullaby-based bathing intervention. Outcome measures include mother-infant bonding, postpartum depressive symptoms, and perceived maternal parenting self-efficacy. Data will be collected at two time points: prior to hospital discharge (within the first 24 hours postpartum) and at the end of the two-week intervention period. Validated self-report instruments will be used for all outcome assessments. The findings of this study are expected to provide evidence on the effectiveness of a simple, culturally embedded caregiving practice in supporting maternal mental health, strengthening mother-infant bonding, and enhancing parenting confidence during the early postpartum period. Results may inform postpartum care practices, parental counseling programs, and midwife-led supportive interventions.

Вмешательства

  • Поведенческое Maternal Lullaby Singing
    Mothers assigned to the intervention group will receive a brief structured education on infant bathing and the emotional role of maternal voice prior to hospital discharge. Following discharge, mothers will bathe their infants at home three times per week for two consecutive weeks (total of six sessions). During each bathing session, mothers will sing a lullaby using their own voice in a calm, quiet, and distraction-free environment. The lullaby may be a traditional cultural lullaby or spontaneo

Первичные конечные точки

  • Mother-Infant Bonding [Срок оценки: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.]
  • Postpartum Depressive Symptoms [Срок оценки: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.]
  • Perceived Maternal Parenting Self-Efficacy [Срок оценки: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.]

Критерии участия

Критерии включения

  • Mothers who have had an uncomplicated pregnancy and delivery
  • Mothers who are healthy enough to care for their baby
  • Mothers who have suitable conditions at home to bathe their baby
  • Babies born at term (≥ 37 weeks of gestation) and with stable general health after birth

Критерии исключения

  • Mothers with a history of serious postpartum complications (such as postpartum hemorrhage)
  • Mothers diagnosed with psychiatric illness
  • Mothers who are unable to participate directly in the care of their baby (due to severe disability, mandatory bed rest, etc.)
  • Mothers who cannot participate in the lullaby program due to hearing impairment
  • Infants who experience serious respiratory, cardiac, or neurological problems at birth or thereafter, who have a skin disease or dermatological condition that limits bathing, who have a history of admission to the neonatal intensive care unit, or who have a chronic disease or congenital anomaly

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
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul University - Cerrahpasa — Istanbul

Идентификаторы

NCT: NCT07370025 · 2025/728

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗