- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07566026
Breathing Exercises During Labor and Maternal Outcomes
Effects of Breathing Exercises During Labor on Maternal Stress, Satisfaction, and Birth Outcomes: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Labor is a physiological process that may be accompanied by pain, anxiety, and psychological stress, which can negatively affect birth satisfaction and labor outcomes. Non-pharmacological interventions such as breathing exercises are widely used to support women during labor.
In this randomized controlled experimental study, pregnant women admitted to the labor and delivery unit during the latent phase were randomly assigned to either an experimental group receiving guided breathing exercises throughout labor or a control group receiving routine intrapartum care only. Breathing exercises were applied continuously during uterine contractions until full cervical dilatation.
Maternal pain intensity, anxiety, traumatic birth perception, birth satisfaction, and labor outcomes including labor duration and obstetric interventions were assessed using validated measurement tools. The study aimed to determine whether breathing exercises could improve maternal psychological well-being, enhance birth satisfaction, and positively influence labor outcomes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Nilgün Avcı
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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 admitted to the labor and delivery unit during the latent phase
- Women planning vaginal birth
- Volunteered to participate
Exclusion Criteria:
- Women who did not speak Turkish
- Women with auditory or mental health problems
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: Breathing Exercise Group
Participants received guided breathing exercises throughout labor in addition to routine intrapartum care.
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Pregnant women were instructed and guided to perform slow, controlled breathing exercises during each uterine contraction from the latent phase until full cervical dilatation.
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Sin intervención: Routine Care Group
Participants received routine intrapartum care only.
No breathing exercises were applied.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Birth Satisfaction
Periodo de tiempo: During the fourth stage of labor (within 2 hours after birth).
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Birth satisfaction assessed using the Short Form of the Birth Satisfaction Scale (BSS-R). Scores range from 0 to 40; higher scores indicate greater satisfaction. |
During the fourth stage of labor (within 2 hours after birth).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Labor Pain Intensity
Periodo de tiempo: Repeatedly during labor from admission to the labor unit until delivery.
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Pain intensity measured using the Visual Analog Scale (VAS).
Scores range from 0 to 10; higher scores indicate more severe pain.
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Repeatedly during labor from admission to the labor unit until delivery.
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Labor-Related Anxiety
Periodo de tiempo: During the fourth stage of labor (within 2 hours after birth).
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Anxiety measured using the Oxford Worries About Labour Scale.
Scores range from 10 to 40; higher scores indicate greater anxiety.
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During the fourth stage of labor (within 2 hours after birth).
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Traumatic Birth Perception
Periodo de tiempo: At admission to the labor unit (baseline) and during the fourth stage of labor (within 2 hours after birth).
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Traumatic birth perception measured using the Traumatic Birth Perception Scale.
Scores range from 0 to 130; higher scores indicate greater traumatic perception.
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At admission to the labor unit (baseline) and during the fourth stage of labor (within 2 hours after birth).
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Fetal Heart Rate During NST
Periodo de tiempo: During the NST monitoring session (approximately 20 minutes, same visit).
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Fetal heart rate assessed from NST recordings during the monitoring session.
Measured in beats per minute; normal patterns indicate better fetal well-being.
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During the NST monitoring session (approximately 20 minutes, same visit).
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Fetal Movement Count During NST
Periodo de tiempo: During the NST monitoring session (approximately 20 minutes, same visit).
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Number of fetal movements recorded by the mother using the event marker during NST monitoring. Higher counts indicate greater fetal activity. |
During the NST monitoring session (approximately 20 minutes, same visit).
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Effects of Breathing Exercises
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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