- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07571785
Showering During Labor
Effects of Showering During Labor on Pain, Anxiety, Comfort, Satisfaction, and Labor Outcomes: A Randomized Controlled Trial
This study examined whether showering during labor affects pain, anxiety, comfort, satisfaction, and labor outcomes in women undergoing vaginal birth. Non-pharmacological methods are commonly used to support women during labor, and warm showering may help reduce discomfort and emotional distress during the labor process.
In this randomized controlled trial, pregnant women in active labor were assigned either to a shower group or to a control group receiving routine labor care. Women in the shower group were allowed to shower during labor under standardized conditions, while the control group received routine intrapartum care without showering. Pain and anxiety levels were assessed repeatedly during labor, while comfort and birth satisfaction were evaluated during and after birth using validated measurement tools.
The results of this study aim to contribute to evidence-based intrapartum care practices by evaluating the role of showering as a supportive intervention during labor.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34010
- State Obstetrics and Gynecology Hospital, Istanbul
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Women admitted to the labor unit during the study period
- Term pregnancy (37-41 weeks)
- Planned vaginal birth
- Cervical dilation greater than 5 cm
- Volunteered to participate and provided informed consent
Exclusion Criteria:
- Inability to communicate in Turkish
- Hearing or mental health conditions
- Conversion from vaginal birth to cesarean section
- Age under 18 years
- High-risk pregnancy (e.g., preeclampsia, diabetes, hypertension, multiple pregnancy, placental abnormalities)
- Use of epidural anesthesia
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: Shower During Labor
Participants were allowed to shower during active labor (cervical dilation >5 cm) in a private bathroom within the labor room.
Showering was permitted at the participant's preference, for at least 20 minutes per session, with water temperature maintained between 35-40°C.
Safety measures were implemented, including accompaniment by a companion or researcher.
|
Participants were allowed to shower during active labor (cervical dilation >5 cm) in a private bathroom within the labor room.
Showering was permitted at the participant's preference, for at least 20 minutes per session, with water temperature maintained between 35-40°C.
Safety measures were implemented, including accompaniment by a companion or researcher.
|
|
Sin intervención: Control: Routine Labor Care
Participants received routine intrapartum care without showering during labor.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Labor Pain Intensity
Periodo de tiempo: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
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Pain intensity assessed using the Visual Analog Scale (VAS) during labor.
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Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety Level During Labor
Periodo de tiempo: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
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Anxiety assessed using the Visual Analog Scale (VAS) during labor.
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Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
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Maternal Comfort During Labor
Periodo de tiempo: At 10 minutes after the first shower session during active labor
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Maternal comfort assessed using the Childbirth Comfort Questionnaire.
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At 10 minutes after the first shower session during active labor
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Birth Satisfaction
Periodo de tiempo: 2 hours postpartum.
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Birth satisfaction assessed using the Birth Satisfaction Scale.
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2 hours postpartum.
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Duration of Labor
Periodo de tiempo: From admission to the labor unit until delivery.
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Total duration of labor measured in hours, obtained from clinical records.
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From admission to the labor unit until delivery.
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Mode of Delivery
Periodo de tiempo: At delivery.
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Type of delivery (vaginal or cesarean) recorded from clinical records.
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At delivery.
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Use of Obstetric Interventions
Periodo de tiempo: During labor and recorded at delivery.
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Use of obstetric interventions (e.g., induction, augmentation, episiotomy) recorded from clinical records.
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During labor and recorded at delivery.
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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
Otros números de identificación del estudio
- Showering During Labor
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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