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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07692724
Effect of Theory-Based Childbirth Preparation Education in Nulliparous Pregnant Women (HBM-SE Birth)
Effect of a Health Belief Model-and Self-Efficacy Theory-Based Childbirth Preparation Education on Fear of Childbirth, Childbirth Self-Efficacy, and Preferred Mode of Delivery in Nulliparous Pregnant Women: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of a Health Belief Model- and Self-Efficacy Theory-based childbirth preparation education on fear of childbirth, childbirth self-efficacy, birth preferences, and childbirth preparation behaviors among nulliparous pregnant women.
Eligible nulliparous pregnant women between 28 and 32 weeks of gestation will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured childbirth preparation education program consisting of four sessions in addition to routine antenatal care, while the control group will receive routine antenatal care only. Data will be collected before the intervention, immediately after the intervention, during follow-up in late pregnancy, and after childbirth. The findings of this study may contribute to improving childbirth-related outcomes by reducing fear of childbirth and enhancing self-efficacy and preparedness for birth.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: sibel akgül kartal
- Número de teléfono: 05012405539
- Correo electrónico: sibelakgulkartal@yyu.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Female Aged 18 years or older Nulliparous pregnancy Between 28 and 32 weeks of gestation Able to communicate in Turkish Willing to participate in the study and provide informed consent
Exclusion Criteria:
High-risk pregnancy Diagnosis or treatment of a psychiatric disorder Any condition that may interfere with communication or participation in the educational sessions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: arm1
Participants in this group will receive a structured childbirth preparation education program based on the Health Belief Model and Self-Efficacy Theory in addition to routine antenatal care.
The program consists of four educational sessions focusing on fear of childbirth, benefits of vaginal birth, coping skills during labor, and childbirth preparation planning.
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A four-session structured educational program designed to reduce fear of childbirth and improve childbirth self-efficacy, birth preferences, and childbirth preparation behaviors among nulliparous pregnant women.
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Comparador activo: arm2
Participants in this group will receive routine antenatal care and standard pregnancy education services provided by the health institution without the structured study intervention.
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Participants will receive routine antenatal care and standard pregnancy education services provided by the health institution.
No structured childbirth preparation education based on the Health Belief Model or Self-Efficacy Theory will be provided.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fear of Childbirth
Periodo de tiempo: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Fear of childbirth will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A).
Higher scores indicate higher levels of fear of childbirth.
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Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Childbirth Self-Efficacy
Periodo de tiempo: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
|
Childbirth self-efficacy will be assessed using the Childbirth Self-Efficacy Inventory Short Form (CBSEI-C32).
Higher scores indicate higher levels of childbirth self-efficacy.
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Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Birth Preference
Periodo de tiempo: Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
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Birth preference will be assessed using the Pregnant Women's Preferences for Mode of Delivery Questionnaire.
Higher scores indicate a stronger preference for vaginal birth.
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Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
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Childbirth Preparation Behaviors
Periodo de tiempo: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Childbirth preparation behaviors will be assessed using the Childbirth Preparation Behavior Form developed by the researchers.
The questionnaire evaluates the extent to which pregnant women engage in behaviors to prepare for childbirth.
Higher scores indicate better childbirth preparation behaviors.
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Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Actual Mode of Delivery
Periodo de tiempo: At the time of childbirth.
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Actual mode of delivery will be recorded using the Birth Record Form and categorized as vaginal birth or cesarean birth.
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At the time of childbirth.
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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
- 251899
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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