Mindfulness-Based Intervention in Primiparous Pregnant Women (MBCP)
Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Pregnancy is a period characterized by significant physical, psychological, and social changes. Fear of childbirth, low childbirth self-efficacy, and difficulties in self-compassion may negatively affect maternal well-being and childbirth experiences. Mindfulness-based interventions have been increasingly used to support psychological health during pregnancy; however, evidence regarding their effects on childbirth self-efficacy, fear of childbirth, and self-compassion remains limited.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based intervention among primiparous pregnant women attending a pregnancy school affiliated with a Healthy Life Center in Ağrı, Türkiye. A total of 128 eligible pregnant women will be randomly assigned to either an intervention group or a control group.
Participants in the intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Participants in the control group will continue to receive routine antenatal education and standard prenatal care.
Data will be collected before and after the intervention using validated instruments assessing childbirth self-efficacy, fear of childbirth, and self-compassion. The results of this study may provide evidence for the integration of mindfulness-based approaches into antenatal care programs to enhance maternal psychological well-being and preparedness for childbirth.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ebru Solmaz, PhD
- Número de teléfono: +905377737260
- Correo electrónico: esolmaz@agri.edu.tr
Ubicaciones de estudio
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Ağrı, Turquía (Türkiye)
- Healthy Life Center Pregnancy School
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Contacto:
- Ebru Solmaz, PhD
- Número de teléfono: +905377737260
- Correo electrónico: esolmaz@agri.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pregnant women aged 18 years and older
- Primiparous women
- Singleton pregnancy
- Gestational age between 28 and 32 weeks
- No known obstetric complications
- Ability to read and understand Turkish
- Attendance at the Pregnancy School of the Healthy Life Center
- Willingness to participate and provide written informed consent
- Willingness to participate in the mindfulness-based intervention program
Exclusion Criteria:
- Multiple pregnancy
- High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)
- Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
- Substance or alcohol dependence
- Previous participation in a structured mindfulness, meditation, or similar awareness-based program
- Inability to attend intervention sessions regularly
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Mindfulness-Based Intervention Group
Participants in this group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, self-compassion, and mindfulness-based coping strategies for childbirth preparation.
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A four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly.
The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation.
Sessions will be delivered face-to-face and will last approximately 60-90 minutes each.
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Sin intervención: Routine Antenatal Care Group
Participants will receive routine antenatal education and standard prenatal care.
No mindfulness-based intervention will be administered.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Childbirth Self-Efficacy
Periodo de tiempo: Baseline and 4 weeks after intervention
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Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.
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Baseline and 4 weeks after intervention
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Fear of Childbirth
Periodo de tiempo: Baseline and 4 weeks after intervention
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Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).
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Baseline and 4 weeks after intervention
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Self-Compassion
Periodo de tiempo: Baseline and 4 weeks after intervention
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Assessment of self-compassion using the Self-Compassion Scale.
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Baseline and 4 weeks after intervention
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
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
Otros números de identificación del estudio
- PMI-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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