- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07784439
Breastfeeding Stories and Video Education in Primiparous Mothers
The Effect of Successful Breastfeeding Stories and Video-Based Education on Breastfeeding Self-Efficacy and Breastfeeding Success in Primiparous Mothers: A Randomized Controlled Trial
The Effect of Successful Breastfeeding Stories and Video-Based Education on Breastfeeding Self-Efficacy and Breastfeeding Success in Primiparous Mothers: A Randomized Controlled Trial
Objective: This study was planned to determine the effect of the combined use of audio recordings based on successful breastfeeding stories and video-based breastfeeding education on breastfeeding self-efficacy and breastfeeding success among primiparous mothers.
Methods: This study will be conducted using a randomized controlled experimental design. The population of the study will consist of primiparous mothers who give birth at the Obstetrics and Gynecology Clinic of Koç University Hospital between September 2026 and February 2027. The sample will consist of a total of 70 primiparous mothers (35 intervention and 35 control) who meet the inclusion criteria and are assigned to the intervention and control groups using a computer-assisted simple randomization method. In addition to routine breastfeeding education provided at the hospital, mothers in the intervention group will receive audio recordings based on successful breastfeeding stories and video-based breastfeeding education. The control group will receive only the routine breastfeeding education provided at the hospital. Data will be collected using the Descriptive Characteristics Form, Postpartum Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH Breastfeeding Assessment Tool, Educational Materials Satisfaction Form, and First-Month Evaluation Form. Data will be analyzed using SPSS version 25.0. Descriptive statistics, independent-samples t-test, paired-samples t-test, chi-square test, and repeated-measures analysis of variance (ANOVA) will be used. The statistical significance level will be accepted as p<0.05.
Expected Results: It is anticipated that the audio recordings based on successful breastfeeding stories and the video-based education program will increase breastfeeding self-efficacy and breastfeeding success among primiparous mothers.
Conclusion: The findings obtained from this study are expected to contribute to the planning of evidence-based nursing interventions aimed at improving breastfeeding self-efficacy and breastfeeding success among primiparous mothers, provide a scientific basis for innovative educational models that can be used to support breastfeeding, and guide the development of standardized breastfeeding education programs that can be implemented in postpartum care services.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Berfin Aydın, BSc
- Número de teléfono: +90 539 894 91 77
- Correo electrónico: aydiinberfin@gmail.com
Ubicaciones de estudio
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ümraniye
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Istanbul, ümraniye, Turquía (Türkiye)
- Koc University Hospital
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Contacto:
- Berfin Aydın, BSc
- Número de teléfono: +90 539 894 91 77
- Correo electrónico: aydiinberfin@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Being 18 years of age or older
- Able to read and write in Turkish
- Being primiparous
- Having given birth to a singleton live birth at >37 weeks of gestation
- Absence of any medical conditions hindering breastfeeding
- Able to use a smartphone
- Voluntary agreement to sign written informed consent
- Having a healthy newborn
- Presence of the sucking reflex in the infant
- Absence of neonatal intensive care unit (NICU) admission requirement
Exclusion Criteria:
- Withdrawal of consent / wishing to leave the study
- Incomplete completion of data collection tools
- Infant experiencing severe health issues requiring hospital readmission
- Loss of contact during the follow-up period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention group
Participants will receive routine hospital breastfeeding education along with audio recordings of successful breastfeeding stories and video-based education.
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In addition to the routine breastfeeding education provided by the hospital, participants in this group receive audio recordings based on successful breastfeeding stories and video-based breastfeeding education.
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Sin intervención: control group
Participants will receive only routine hospital breastfeeding education.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Breastfeeding Self-Efficacy Scale Short Form (BSES-SF) Score
Periodo de tiempo: Baseline (within first 24 hours postpartum) and Postpartum 1st Month (Day 30)
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Assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).
Total scores range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
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Baseline (within first 24 hours postpartum) and Postpartum 1st Month (Day 30)
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LATCH Breastfeeding Assessment Tool Score
Periodo de tiempo: Baseline (within first 24 hours postpartum) and Discharge day (Day 2-3)
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Evaluates breastfeeding performance across 5 parameters (Latch, Audible swallowing, Type of nipple, Comfort, Hold).
Total scores range from 0 to 10, with higher scores indicating higher breastfeeding success.
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Baseline (within first 24 hours postpartum) and Discharge day (Day 2-3)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
First-Month Evaluation Form
Periodo de tiempo: Postpartum 1st Month (Day 30)
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Administered by the researcher via phone or online communication methods at the 1st month postpartum.
The researcher reads the questions to the participant without guidance and records the responses to evaluate breastfeeding status and outcomes.
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Postpartum 1st Month (Day 30)
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Education Satisfaction Form Score
Periodo de tiempo: Discharge day (Day 2-3)
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Evaluates the participants' level of satisfaction with the educational materials provided.
Assessed using a structured questionnaire.
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Discharge day (Day 2-3)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026.332.IRB3.124
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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