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Набор скоро начнётся NCT07037914

The Impact of the Nurse-Led "My Baby is Safe" Educational Program

Без фазы С лечением Sudden Infant Death Syndrome Shaken Baby Syndrome

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: Education and Counseling, Leaflet.
Кому может быть актуально
Состояния в реестре: Sudden Infant Death Syndrome, Shaken Baby Syndrome. Базовые параметры: 18 лет — 65 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Impact of the Nurse-Led "My Baby is Safe" Educational Program on Mothers' Knowledge, Skills, and Self-Efficacy

Обзор

The aim of this study is to determine the effect of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy levels.The objectives of the study are to ensure that mothers acquire sufficient knowledge and skills regarding SIDS and SBS, and to enhance their self-efficacy levels.The participants were randomly assigned to one group that received only the My Baby is Safe Educational Program (Group I), or to another group that received standard care (Group II).

Подробное описание

The aim of this randomized controlled study was to determine the effectiveness of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy related to the prevention of Sudden Infant Death Syndrome (SIDS) and Shaken Baby Syndrome (SBS).

This study, which included postpartum mothers, was conducted at Amasya University between July 2025 and July 2026. Participants were randomly assigned to either the intervention group, which received the My Baby is Safe Educational Program (Group I), or the control group, which received standard care (Group II).

The intervention consisted of a nurse-led, individualized, repetitive educational program that began in the postpartum period and included home visits. The program aimed to inform mothers about risk and protective factors for SIDS and SBS, to encourage the creation and maintenance of a safe sleep environment, and to promote the use of appropriate soothing techniques for crying infants.

The study sample consisted of 50 mothers, with 25 mothers assigned to each group. Data collection instruments included: the Infant and Parent Information Form, Sudden Infant Death Syndrome Awareness Scale - Mother Form, the Sudden Infant Death Syndrome Care Skills Form, the Shaken Baby Syndrome Awareness Assessment Scale-Short Form, the Shaken Baby Syndrome Care Skills Form, the Sleep Environment Checklist, and the Perceived Maternal Parenting Self-Efficacy Scale.

Data were analyzed using the licensed Statistical Package for the Social Sciences (SPSS v.23) software of Akdeniz University. Repeated measures ANOVA was used to evaluate the changes over time between the groups and the interaction effects between group and time. Spearman correlation analysis was performed to assess relationships between variables. The significance level was set at p\<0.05. Additionally, effect sizes were calculated.

As a result, it is anticipated that the My Baby is Safe Educational Program will improve mothers' knowledge, skills, and self-efficacy related to the prevention of SIDS and SBS.

Вмешательства

  • Поведенческое Education and Counseling
    The researcher will inform the mothers (n=25) that the My Baby is Safe Educational Program will be delivered individually through distance education via Microsoft Teams at times convenient for them, and that the program will be completed over 5 days. The scheduling will ensure that all modules included in the My Baby is Safe Educational Program are completed within one week at the latest. Mothers will be informed that they can receive telephone counseling from the researcher until their infants
  • Другое Leaflet
    No structured or planned education will be provided to the control group by the researchers during the study period. After the first assessment, the mothers in the control group will receive a brochure prepared by the researchers based on the literature, containing brief informational notes on SIDS and SBS. The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this visit, the researcher will observe the home environment where the

Первичные конечные точки

  • Sudden Infant Death Syndrome Awareness [Срок оценки: baseline (first assessment)]
  • Sudden Infant Death Syndrome Awareness [Срок оценки: at the end of the invervention program (8 weeks after from baseline)]
  • Sudden Infant Death Syndrome Care Skills [Срок оценки: baseline (first assessment)]
  • Sudden Infant Death Syndrome Care Skills [Срок оценки: a home visit on the 15th day postpartum (2 weeks after from baseline)]
  • Sudden Infant Death Syndrome Care Skills [Срок оценки: at the end of the invervention program (8 weeks after from baseline)]
  • Shaken Baby Syndrome Awareness [Срок оценки: baseline (first assessment)]
  • Shaken Baby Syndrome Awareness [Срок оценки: at the end of the invervention program (8 weeks after from baseline)]
  • Shaken Baby Syndrome Care Skills [Срок оценки: baseline (first assessment)]
  • Shaken Baby Syndrome Care Skills [Срок оценки: a home visit on the 15th day postpartum (2 weeks after from baseline)]
  • Shaken Baby Syndrome Care Skills [Срок оценки: at the end of the invervention program (8 weeks after from baseline)]
Вторичные конечные точки (1)
  • Sleep Environment [Срок оценки: a home visit on the 15th day postpartum (2 weeks after from baseline)]

Критерии участия

Критерии включения

  • Aged 18 years or older,
  • Having a healthy newborn,
  • Having one or more children,
  • Having at least a primary school education,
  • Having a smartphone and mobile internet access,
  • Being able to speak, read, listen, and understand Turkish, able to follow instructions, and having no communication barriers,
  • Voluntarily agreeing to participate in the study.

Критерии исключения

  • Mothers whose newborns have any health problems will be excluded from the study.
  • Mothers who wish to withdraw from the study at any point during the research process will be removed from the study.
  • did not complete the process of the assessment and intervention of this study.

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
Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр
  • Amasya University — Amasya

Идентификаторы

NCT: NCT07037914 · 13062025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗