- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07571785
Showering During Labor
Effects of Showering During Labor on Pain, Anxiety, Comfort, Satisfaction, and Labor Outcomes: A Randomized Controlled Trial
This study examined whether showering during labor affects pain, anxiety, comfort, satisfaction, and labor outcomes in women undergoing vaginal birth. Non-pharmacological methods are commonly used to support women during labor, and warm showering may help reduce discomfort and emotional distress during the labor process.
In this randomized controlled trial, pregnant women in active labor were assigned either to a shower group or to a control group receiving routine labor care. Women in the shower group were allowed to shower during labor under standardized conditions, while the control group received routine intrapartum care without showering. Pain and anxiety levels were assessed repeatedly during labor, while comfort and birth satisfaction were evaluated during and after birth using validated measurement tools.
The results of this study aim to contribute to evidence-based intrapartum care practices by evaluating the role of showering as a supportive intervention during labor.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Istanbul
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Istanbul, Istanbul, Турция (Туркие), 34010
- State Obstetrics and Gynecology Hospital, Istanbul
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Women admitted to the labor unit during the study period
- Term pregnancy (37-41 weeks)
- Planned vaginal birth
- Cervical dilation greater than 5 cm
- Volunteered to participate and provided informed consent
Exclusion Criteria:
- Inability to communicate in Turkish
- Hearing or mental health conditions
- Conversion from vaginal birth to cesarean section
- Age under 18 years
- High-risk pregnancy (e.g., preeclampsia, diabetes, hypertension, multiple pregnancy, placental abnormalities)
- Use of epidural anesthesia
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Shower During Labor
Participants were allowed to shower during active labor (cervical dilation >5 cm) in a private bathroom within the labor room.
Showering was permitted at the participant's preference, for at least 20 minutes per session, with water temperature maintained between 35-40°C.
Safety measures were implemented, including accompaniment by a companion or researcher.
|
Participants were allowed to shower during active labor (cervical dilation >5 cm) in a private bathroom within the labor room.
Showering was permitted at the participant's preference, for at least 20 minutes per session, with water temperature maintained between 35-40°C.
Safety measures were implemented, including accompaniment by a companion or researcher.
|
|
Без вмешательства: Control: Routine Labor Care
Participants received routine intrapartum care without showering during labor.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Labor Pain Intensity
Временное ограничение: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
Pain intensity assessed using the Visual Analog Scale (VAS) during labor.
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Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Anxiety Level During Labor
Временное ограничение: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
Anxiety assessed using the Visual Analog Scale (VAS) during labor.
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Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
|
Maternal Comfort During Labor
Временное ограничение: At 10 minutes after the first shower session during active labor
|
Maternal comfort assessed using the Childbirth Comfort Questionnaire.
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At 10 minutes after the first shower session during active labor
|
|
Birth Satisfaction
Временное ограничение: 2 hours postpartum.
|
Birth satisfaction assessed using the Birth Satisfaction Scale.
|
2 hours postpartum.
|
|
Duration of Labor
Временное ограничение: From admission to the labor unit until delivery.
|
Total duration of labor measured in hours, obtained from clinical records.
|
From admission to the labor unit until delivery.
|
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Mode of Delivery
Временное ограничение: At delivery.
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Type of delivery (vaginal or cesarean) recorded from clinical records.
|
At delivery.
|
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Use of Obstetric Interventions
Временное ограничение: During labor and recorded at delivery.
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Use of obstetric interventions (e.g., induction, augmentation, episiotomy) recorded from clinical records.
|
During labor and recorded at delivery.
|
Соавторы и исследователи
Спонсор
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
Другие идентификационные номера исследования
- Showering During Labor
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. .