- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT06628986
MBSR и НЛП, Послеродовое грудное вскармливание и депрессия (postpartum)
Влияние приложений MBSR и НЛП на утомляемость, качество сна, лактацию и послеродовую депрессию в послеродовом периоде после кесарева сечения
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Eyalet/Yerleşke
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Sanliurfa, Eyalet/Yerleşke, Турция (Туркие), 63000
- Şanlıurfa training and research hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 19-35 years old
- caesarean section
- primiparous
- breastfeeding women
Exclusion Criteria:
- women who refused to participate in the research.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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
Другие имена:
|
|
Экспериментальный: 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
Другие имена:
|
|
Экспериментальный: control
control; MBSR and NLP applications will not be performed. Mothers will be monitored online every week. |
control group, no practice,
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Visual Analogue Scale for Fatigue (VAS-F)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: before the first application
|
Exclusive breastfeeding status (yes or no) |
before the first application
|
|
Exclusive breastfeeding status
Временное ограничение: 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
Временное ограничение: week 8, following the final intervention
|
Exclusive breastfeeding status (yes or no) |
week 8, following the final intervention
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: AYŞEGÜL KILIÇLI, Dr., Muş Alparslan University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Психические расстройства
- Женские мочеполовые заболевания и осложнения беременности
- Осложнения беременности
- Расстройства настроения
- Послеродовые расстройства
- Депрессивное расстройство
- Патологические состояния, признаки и симптомы
- Поведение
- Признаки и симптомы
- Кормление Поведение
- Усталость
- Депрессия, послеродовая
- Кормление грудью
- Следственные методы
- Эпидемиологический дизайн исследований
- Эпидемиологические методы
- Расширение исследования
- Методы
- Контрольные группы
Другие идентификационные номера исследования
- Mauniv
Планирование данных отдельных участников (IPD)
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Описание плана IPD
All
Сроки обмена IPD
8 October 2024 - 30 October 2025
Критерии совместного доступа к IPD
8 October 2024 - 30 October 2025
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .