- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07831785
Supportive Care During Childbirth in Syrian Migrant Women
Comparison of Childbirth Satisfaction, Breastfeeding Self-Efficacy, and Perceived Stress in Syrian Migrant Women Receiving and Not Receiving Supportive Care During Childbirth
This randomized controlled trial aims to evaluate the effects of structured supportive midwifery care provided during labor on childbirth satisfaction, breastfeeding success, breastfeeding self-efficacy, and perceived stress among Syrian migrant women. A total of 100 eligible women admitted to the delivery unit of Yuregir State Hospital in Adana, Türkiye, will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Women in the intervention group will receive structured supportive midwifery care in addition to routine hospital care, whereas women in the control group will receive routine maternity care. The supportive care intervention will include physical support, emotional support, informational and communication support, and advocacy throughout labor. Outcomes will be assessed using validated measurement tools during the childbirth and early postpartum periods.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This study is designed as a two-arm, parallel-group, randomized controlled trial. The study population will consist of Syrian migrant women admitted in active labor to the Delivery Unit of Yuregir State Hospital in Adana, Türkiye, who meet the eligibility criteria and provide written informed consent.
A total of 100 participants will be randomized in a 1:1 ratio to the intervention group (n=50) or control group (n=50). A variable block randomization procedure using block sizes of 4 and 6 will be used. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes.
Participants assigned to the intervention group will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four main components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes measures such as mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and other comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational support includes explanations about the labor process, procedures, breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy focuses on supporting women's preferences, participation in decision-making, privacy, and communication with healthcare professionals.
Participants assigned to the control group will receive the routine labor and postpartum care provided by the hospital without the additional structured supportive care intervention delivered by the researcher.
Study outcomes include childbirth satisfaction, breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool, postpartum breastfeeding self-efficacy, and perceived stress. Data will be collected at predefined time points from the beginning of labor through the first 24 hours postpartum.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Özlem KOÇ, PhD
- Номер телефона: 05520839594
- Электронная почта: ozlemkoc@tarsus.edu.tr
Места учебы
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Adana, Турция (Туркие)
- Adana Yuregir State Hospital
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Контакт:
- Fatma KEÇE
- Номер телефона: +90 05347857596
- Электронная почта: 254131005@tarsus.edu.tr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Syrian migrant women admitted to the Delivery Unit of Adana Yüreğir State Hospital due to labor.
- Aged 18 years or older.
- Gestational age between 37 and 42 weeks.
- Singleton, live pregnancy.
- Fetus in cephalic presentation.
- Spontaneous vaginal labor initiated and in the active phase of labor.
- Able to communicate in Arabic or Turkish at a level sufficient to understand the data collection instruments and the intervention to be applied.
- Voluntarily agreeing to participate in the study and providing informed consent.
Exclusion Criteria:
- Having a planned (elective) cesarean delivery decision at the time of admission.
- Having an obstetric condition contraindicating vaginal delivery.
- Having a high-risk pregnancy or labor condition, including severe preeclampsia, eclampsia, placenta previa, or placental abruption.
- Multiple pregnancy.
- Intrauterine fetal death or a major fetal anomaly incompatible with life.
- Having a maternal or fetal clinical condition requiring emergency obstetric intervention at the time of admission for labor.
- Having a cognitive impairment or severe psychiatric condition that would prevent participation, communication, or the informed consent process.
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 |
|---|---|
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Экспериментальный: Structured Supportive Midwifery Care
Participants assigned to this arm will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. Supportive care includes physical support, emotional support, informational and communication support, and advocacy. |
Structured supportive midwifery care will be provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational and communication support includes explanations about the labor process and procedures, guidance on breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy includes supporting the woman's preferences, participation in decision-making, privacy, and communication with healthcare professionals. |
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Активный компаратор: Routine Care
Participants assigned to this arm will receive the routine labor and postpartum care provided by Yuregir State Hospital. No additional structured supportive midwifery care will be provided by the researcher. |
Structured supportive midwifery care will be provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational and communication support includes explanations about the labor process and procedures, guidance on breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy includes supporting the woman's preferences, participation in decision-making, privacy, and communication with healthcare professionals. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Childbirth Satisfaction
Временное ограничение: At 24 hours postpartum
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Childbirth satisfaction will be assessed using the Mackey Childbirth Satisfaction Rating Scale (MCSRS). The scale consists of 34 items rated on a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). The total score ranges from 34 to 170, with higher scores indicating greater satisfaction with the childbirth experience. |
At 24 hours postpartum
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Özlem KOÇ, Tarsus University, Faculty of Health Sciences, Department of Midwifery
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Другие идентификационные номера исследования
- FKECE-RCT-2026-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Individual participant data will not be shared.
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. .