- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06628986
MBSR y PNL, Lactancia Materna Posparto y Depresión (postpartum)
el efecto de las aplicaciones de MBSR y PNL sobre la fatiga, la calidad del sueño, la lactancia y la depresión posparto en el período posparto después de una cesárea
The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The postnatal period is a risky period in which retrogressive and progressive changes and rapid biopsychosocial changes occur in mothers. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes occurring in this period. Studies have reported that the most common physical problems in the early postpartum period after caesarean section are pain in the incision area, difficulty in caring for the baby alone, activity intolerance, fatigue, insomnia, breastfeeding problems (such as nipple or lack of milk), mastitis and abdominal tension/gas. As important as it is to reduce postpartum symptoms after caesarean section, it is also important to support and maintain breastfeeding. However, postpartum symptoms such as pain, fatigue and negative effects of anaesthesia after caesarean section negatively affect the breastfeeding process and lead to a delay in the onset of lactation.
When the literature was examined, no study was found that examined the effects of mindfulness-based stress reduction programme and neurolinguistic programme on fatigue, sleep quality, lactation and depression in the postpartum long term.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Eyalet/Yerleşke
-
Sanliurfa, Eyalet/Yerleşke, Turquía (Türkiye), 63000
- Şanlıurfa training and research hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 19-35 years old
- caesarean section
- primiparous
- breastfeeding women
Exclusion Criteria:
- women who refused to participate in the research.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mindfulness-based stress reduction program
MBSR; Mindfulness-based stress reduction program. 8 weeks of practice once a week for 20 minutes each. Mindfulness-based stress reduction practices will be carried out online. Mothers will actively participate. |
20 minutes once a week for 8 weeks
Otros nombres:
|
|
Experimental: Neurolinguistic programming
NLP; Neurolinguistic programming 8 weeks of practice once a week for 20 minutes each. Neurolinguistic programming will be carried out online. Mothers will actively participate. |
NLP Neurolinguistic programming, 20 minutes once a week for 8 weeks
Otros nombres:
|
|
Experimental: control
control; MBSR and NLP applications will not be performed. Mothers will be monitored online every week. |
control group, no practice,
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analogue Scale for Fatigue (VAS-F)
Periodo de tiempo: before the first application
|
Visual Analogue Scale for Fatigue (VAS-F), The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. |
before the first application
|
|
Visual Analogue Scale for Fatigue (VAS-F)
Periodo de tiempo: Week 4, following the intervention administered on that day
|
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. |
Week 4, following the intervention administered on that day
|
|
Visual Analogue Scale for Fatigue (VAS-F)
Periodo de tiempo: Week 8, following the final intervention
|
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. |
Week 8, following the final intervention
|
|
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: before the first application
|
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep. |
before the first application
|
|
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: week 4, following the intervention administered on that day
|
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep. |
week 4, following the intervention administered on that day
|
|
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: week 8, , following the final intervention
|
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep. |
week 8, , following the final intervention
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Periodo de tiempo: before the first application
|
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression. |
before the first application
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Periodo de tiempo: week 4, following the intervention administered on that day
|
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression. |
week 4, following the intervention administered on that day
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Periodo de tiempo: week 8, following the final intervention
|
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression. |
week 8, following the final intervention
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Periodo de tiempo: before the first application
|
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
before the first application
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Periodo de tiempo: week 4, following the intervention administered on that day
|
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
week 4, following the intervention administered on that day
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Periodo de tiempo: week 8, following the final intervention
|
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
week 8, following the final intervention
|
|
Exclusive breastfeeding status
Periodo de tiempo: before the first application
|
Exclusive breastfeeding status (yes or no) |
before the first application
|
|
Exclusive breastfeeding status
Periodo de tiempo: week 4, following the intervention administered on that day
|
Exclusive breastfeeding status (yes or no) |
week 4, following the intervention administered on that day
|
|
Exclusive breastfeeding status
Periodo de tiempo: week 8, following the final intervention
|
Exclusive breastfeeding status (yes or no) |
week 8, following the final intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: AYŞEGÜL KILIÇLI, Dr., Muş Alparslan University
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
- Enfermedades urogenitales
- Desordenes mentales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Trastornos del estado de ánimo
- Trastornos Puerperales
- Desorden depresivo
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Comportamiento de alimentación
- Fatiga
- Depresión, Posparto
- Lactancia Materna
- Técnicas de investigación
- Diseño de investigación epidemiológica
- Métodos epidemiológicos
- Diseño de la investigación
- Métodos
- Grupos de control
Otros números de identificación del estudio
- Mauniv
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
All
Marco de tiempo para compartir IPD
8 October 2024 - 30 October 2025
Criterios de acceso compartido de IPD
8 October 2024 - 30 October 2025
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .