- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07777107
Warm and Cool Color Visual Focusing in Labor
EFFECTS OF FOCUSING ON WARM VERSUS COOL COLOR VISUALS DURING LABOR ON PAIN, ANXIETY, COMFORT, AND LABOR DURATION: A RANDOMIZED CONTROLLED TRIAL
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Balıkesir, Turquía (Türkiye), 6100
- Balıkesir University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Nulliparous pregnant women Singleton pregnancy Term pregnancy (37-42 weeks of gestation) Cephalic fetal presentation Spontaneous onset of labor Cervical dilatation of 1 cm at enrollment Ability to communicate in Turkish Voluntary participation in the study -
Exclusion Criteria:
High-risk pregnancy or obstetric complications Presence of a condition requiring emergency obstetric intervention Use of pharmacological analgesia during labor Visual impairment that could interfere with focusing on the visual Development of maternal or fetal complications requiring discontinuation of the intervention
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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: Warm-color group
A visual dominated by warm colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
Standard midwifery care was provided.
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A visual dominated by warm colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
|
|
Experimental: Cool-color group
A visual dominated by cool colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
Standard midwifery care was provided.
|
A visual dominated by cool colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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labor pain
Periodo de tiempo: At 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation during labor.
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Labor pain intensity was assessed using the Visual Analog Scale (VAS) at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation.
The VAS ranges from 0 to 10, with higher scores indicating greater pain intensity.
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At 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation during labor.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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State Anxiety
Periodo de tiempo: At 6-7 cm cervical dilatation during labor.
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State anxiety was assessed using the State Anxiety Inventory (STAI-I) at 6-7 cm cervical dilatation.
The scale consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.
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At 6-7 cm cervical dilatation during labor.
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Childbirth Comfort
Periodo de tiempo: At 4-5 cm and 8-10 cm cervical dilatation during labor.
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Childbirth comfort was assessed using the Childbirth Comfort Questionnaire (CCQ) at 4-5 cm and 8-10 cm cervical dilatation.
Higher scores indicate higher levels of childbirth comfort.
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At 4-5 cm and 8-10 cm cervical dilatation during labor.
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Labor Duration
Periodo de tiempo: From 4 cm to 10 cm cervical dilatation during labor.
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Labor duration was determined by recording the time elapsed from 4 cm cervical dilatation to full cervical dilatation (10 cm).
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From 4 cm to 10 cm cervical dilatation during labor.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Turkmen H, Cetinkaya S, Kilic H, Apay E, Karamuftuoglu D, Yoruk S, Ozkirim E. Effect of Focusing on Maryam's Flower During the First Stage of the Labor on the Labor Pain, Labor Duration, and Levels of Comfort and Satisfaction. Clin Nurs Res. 2021 Jul;30(6):780-789. doi: 10.1177/1054773820984911. Epub 2020 Dec 29.
- Turkmen H, Cetinkaya S, Kilic H, Tuna SD, Sirvanci M, Mutlu H. The Effect of Ice Massage Applied to the SP6 Point on Labor Pain, Labor Comfort, Labor Duration, and Anxiety: A Randomized Clinical Trial. J Midwifery Womens Health. 2024 Jul-Aug;69(4):491-498. doi: 10.1111/jmwh.13600. Epub 2024 Jan 15.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Balikesirhulya
Plan de datos de participantes individuales (IPD)
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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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