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Идёт набор NCT06750796

The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression

Без фазы С лечением Infant, Newborn Maternal Outcome

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: The Half Swaddling Application.
Кому может быть актуально
Состояния в реестре: Infant, Newborn, Maternal Outcome. 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

The Effect of Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality and Postpartum Depression in Term Infants

Обзор

In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression.

Подробное описание

In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression. half swaddling; Half swaddling applied to a newborn baby makes the baby feel completely safe as if they are still in the womb. After laying the soft fabric or baby blanket, it will be placed in the supine position. It is swaddling in a way that does not restrict the movement of the baby's arms and legs too much. n=128 (64=control, 64=half swaddling group) mothers and babies who volunteered to participate in the study will be randomized into two groups as case and control. In the half stock group; From the 1st to the 3rd month, half swaddling will be done 15 minutes before each sleep during the day. 0 (first meeting), 1, 2 and 3 months will be interviewed by phone for follow-up purposes.

Вмешательства

  • Поведенческое The Half Swaddling Application
    Half swaddling application in term babies

Первичные конечные точки

  • Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months [Срок оценки: Postpartum first 3 months]
  • Pittsburgh Sleep Quality Index [Срок оценки: up to 3 months]
  • Edinburgh Postnatal Depression Scale [Срок оценки: up to 3 months]
  • Short Infant Sleep Routine Questionnaire [Срок оценки: up to 3 months]

Критерии участия

Критерии включения

  • 18-45 years old,
  • Term birth (single birth over 37 weeks),
  • After an uncomplicated pregnancy process, the delivery was completed by normal vaginal or cesarean delivery method,
  • Not using cigarettes, alcohol and stimulants,
  • BMI<30,
  • Not working on night shift,
  • Stable vital signs,
  • Those who have not received infertility treatment,
  • Do not have a chronic disease (such as hypertension, diabetes mellitus),
  • Not experiencing serious depression, anxiety and stress,
  • Not having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
  • No serious maternal complications,
  • Mothers who volunteered to participate in the study will be included in the study.

For baby;

  • Birth weight over 2500 g,
  • Stable vital signs,
  • APGAR score above 7,
  • No serious neonatal complications,
  • Midwives without congenital malformations will be included in the study.

Критерии исключения

  • under 18 years old,
  • Preterm birth (under 37 weeks and/or multiple births),
  • Incomplete delivery by normal vaginal or cesarean delivery method after a complicated pregnancy process,
  • Using cigarettes, alcohol and stimulants,
  • BMI>30,
  • Working night shift,
  • No stable vital signs,
  • Having received infertility treatment,
  • Having a chronic disease (such as hypertension, diabetes mellitus),
  • Experiencing severe depression, anxiety and stress,
  • Having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
  • Serious maternal complication,
  • Mothers who do not volunteer to participate in the study will not be included in the study.

For baby;

  • Birth weight of 2500 g and below,
  • No stable vital signs,
  • APGAR score below 7,
  • Serious neonatal complication,
  • Babies with congenital malformations will not be included in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Trakya University — Edirne

Публикации

  • Sobaihi M, Banjari MA, Alahmadi TS. Implementation of Safe Sleep Practice Recommendations for Infants in Inpatient Wards. Cureus. 2020 Oct 25;12(10):e11155. doi: 10.7759/cureus.11155. PMID 33251063

Идентификаторы

NCT: NCT06750796 · Prospective controlled study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗