- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06922682
Entrenamiento sobre el síndrome de muerte repentina (SIDS)
El efecto de proporcionar capacitación de mujeres embarazadas en el Síndrome de Muerte Infantil (SMSM) repentino en los comportamientos de riesgo posparto: ensayo controlado aleatorizado
Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. The study aims examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors. To examine effects of training provided to pregnant women about risk factors triggering sudden infant death syndrome before birth on the post-partum knowledge level and behaviors of mothers. Pre-test post-test designed, randomized controlled, experimental study was conducted in Turkey, 2024. Sixty pregnant women were employed in intervention and control groups. Face-to-face training on risk factors triggering sudden infant death syndrome was provided to pregnant women in intervention group. Study data were collected using "Personal Information Form, Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire". Data were collected face to face before training and after training and via telephone 2 months after training.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Black Sea Zone
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Samsun, Black Sea Zone, Turquía (Türkiye), 55100
- Samsun Gynecology and Children's Diseases Hospital in Turkey
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pregnant women who were in the 38th week of their pregnancy and older,
- Lived a healthy pregnancy,
- Had no communication problems,
- Can speak and understand Turkish,
- Agreed to participate in the study were included.
Exclusion Criteria:
- Pregnant women who were earlier than 38 weeks pregnant,
- Had difficulty in communicating,
- Were illiterate and unable to speak Turkish,
- Who filled out the forms incompletely were not included.
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: Intervention Group
Pregnant women in their 38th week of pregnancy and later, who visited the hospital to have their NST scans, were then invited to the training with the Risk Factors Triggering Sudden Infant Death Syndrome Training Booklet |
Sudden Infant Death Syndrome Training Booklet was prepared. Prgenant women who agreed to participate were provided a face-to-face training on the risk factors triggering sudden infant death syndrome through the booklet. Following the educational session, they received the safe sleep handout to use at home and were informed that the researcher would call them two months later to check on their adherence to safe sleep practices. Following the training, participants were re-administered the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire and the training booklet was given to them as a gift. Two months after the training, the pregnant women were contacted via phone and they were required to fill out the Knowledge Level on Sudden Infant Death Syndrome and Risky Behavior Identification Questionnaire once again. |
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Sin intervención: Control Group
Pregnant women in this group were not provided a specific training on the risk factors triggering sudden infant death syndrome. The clinic has already offered a pregnancy school where routine prenatal care training is provided. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knowledge Level on SID Identification Questionnaire
Periodo de tiempo: 20 minutes before training, just after training and 2 month later
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Questionnaire, developed by authors consists of 2 sections. First section aims to determine knowledge level of pregnant women about sudden infant death syndrome. Questionnaire consisting of 17 questions are answered as true, false, or I do not know. Items answered as "True" are scored 1 point, whereas items answered as "False" or "I don't know" are scored as 0. Questionnaire includes reverse coded items. The lowest possible score in the questionnaire is 0 and the highest possible score is 17. The second section consists of questions aiming to determine the risky behaviors of pregnant women that may cause sudden infant death syndrome. A total of 26 questions in this section are answered as never (1 point), rarely (2 points), sometimes (3 points), often (4 points) and always (5 points). The questionnaire includes reverse coded items; the lowest and the highest possible scores in the questionnaire are 26 and 130, respectively. |
20 minutes before training, just after training and 2 month later
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hatice Uzsen, PHD, Ondokuz Mayis Univeristy
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
- 2023/124
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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