- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07572786
Effect of Electroacupuncture on Bowel Function and Quality of Life in Postpartum Constipation: A Randomized Controlled Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
to evaluate the effect of electroacupuncture on improving bowel function and reducing symptoms of postpartum constipation compared to standard care.
Study population & Sample size: (no more than 3 lines) Postpartum women aged 20-40 years diagnosed with constipation. A randomized controlled trial with two parallel groups: an electroacupuncture group and a control group receiving abdominal exercises . Participants will be randomly assigned using a simple randomization method.
Diagnosis:
Postpartum constipation diagnosed based on clinical criteria (e.g., Rome IV criteria).
Groups:
- Group A: Electroacupuncture + abdominal exercises
- Group B: abdominal exercises only
Inclusion Criteria:
- Females aged 20-40 years
- Within 6 weeks postpartum
- Diagnosed with constipation
- Willing to participate
Exclusion Criteria:
- History of gastrointestinal disorders
- Previous colorectal surgery
- Neurological diseases affecting bowel function
- Contraindications to acupuncture (tumor, scar or keloids & spinal instability ).
Measuring Tools:
- Bristol Stool Form Scale This scale will be used to assess stool consistency, which is classified into seven distinct types ranging from hard lumps to entirely liquid stool. It is considered an important indicator of intestinal transit time. The Bristol Stool Form Scale is widely validated and demonstrates high reliability and reproducibility in clinical and research settings. In this study, it will be used as a primary outcome measure to evaluate changes in bowel habits, either independently or alongside bowel movement frequency.
Patient Assessment of Constipation Quality of Life (PAC-QOL) This questionnaire will be used to evaluate the impact of constipation on patients' daily life, including physical discomfort, psychosocial effects, and overall satisfaction. The PAC-QOL has excellent psychometric properties, including strong validity and reliability. In this study, it will be used as a secondary outcome measure to assess improvements in quality of life following the intervention.
- Evaluation procedures All participants will undergo a standardized evaluation before and after the intervention period. Baseline assessment will be conducted prior to randomization to ensure comparability between groups.
At the beginning of the study, demographic and clinical data will be collected, including age, parity, mode of delivery, and time since delivery. Participants will then be evaluated for constipation severity and bowel habits.
Stool consistency will be assessed using the Bristol Stool Form Scale, where participants will classify their stool type according to the seven-point scale. In addition, participants will be instructed to record bowel movement frequency per week using a bowel diary.
Quality of life related to constipation will be evaluated using the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. This tool will assess the physical, psychological, and social impact of constipation on daily living.
All outcome measures will be recorded at baseline (pre-treatment) and at the end of the treatment period (post-treatment). Participants will also be monitored throughout the study to ensure compliance and to document any adverse effects.
• Treatment procedures The electroacupuncture group will receive treatment sessions 3 times per week for 6 weeks using Quchi (LI11) and Shangjuxu (ST37) acupoints added to abdominal exercises . The control group will receive abdominal exercises only.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: shaimaa MH elmarakby
- Номер телефона: 01008585299
- Электронная почта: shaimaa.mohamed@pt.mti.edu.eg
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Females aged 20-40 years
- Within 6 weeks postpartum
- Diagnosed with constipation
- Willing to participate
Exclusion Criteria:
- History of gastrointestinal disorders
- Previous colorectal surgery
- Neurological diseases affecting bowel function
- Contraindications to acupuncture (tumor, scar or keloids & spinal instability ).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: electro acupuncture group
Participants in this group will receive electroacupuncture therapy applied to Quchi (LI11) and Shangjuxu (ST37) acupoints plus abdominal exercises Treatment will be administered [12 sessions per week] for [6 weeks], with each session lasting approximately [30 minutes].
The intervention aims to improve bowel function in postpartum constipation.
|
This study is expected to contribute significantly to maternal healthcare in Egypt by addressing postpartum constipation, a common yet often neglected condition affecting women after childbirth. Constipation can negatively impact quality of life, causing discomfort, pain, and psychological distress. Electroacupuncture offers a safe, non-pharmacological, and cost-effective treatment alternative. This is particularly important for postpartum women who may avoid medications due to breastfeeding concerns or side effects. The findings of this study may support the integration of electroacupuncture into routine postpartum care in Egypt, especially within physical therapy and rehabilitation programs. It may also help reduce dependence on laxatives and improve patient satisfaction. Static Abdominal Contractions Lie on your back in "crook lying" (knees bent, feet flat). Gently contract all abdominal muscles (as if bracing for a light punch), hold 5-10 seconds, then release. Repeat. Keep breathing normally. This strengthens the abdominal wall to improve bowel support and tone. Activation and exercise of the transverse abdominis muscle has been noted as important, as it brings together the bellies of the rectus abdominus muscle, improving the integrity of the linea alba and increasing fascial tension. While studied primarily for diastasis recti, these exercises engage the deep core and can support improved abdominal function overall. |
|
Активный компаратор: control group
Participants in this group will perform a structured abdominal exercise program designed to improve bowel motility.
Exercises will be conducted [12 sessions per week] for [6 weeks], with each session lasting approximately [20 minutes].
|
Static Abdominal Contractions Lie on your back in "crook lying" (knees bent, feet flat). Gently contract all abdominal muscles (as if bracing for a light punch), hold 5-10 seconds, then release. Repeat. Keep breathing normally. This strengthens the abdominal wall to improve bowel support and tone. Activation and exercise of the transverse abdominis muscle has been noted as important, as it brings together the bellies of the rectus abdominus muscle, improving the integrity of the linea alba and increasing fascial tension. While studied primarily for diastasis recti, these exercises engage the deep core and can support improved abdominal function overall. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Bristol Stool Form Scale
Временное ограничение: 6 weeks
|
This scale will be used to assess stool consistency, which is classified into seven distinct types ranging from hard lumps to entirely liquid stool.
It is considered an important indicator of intestinal transit time.
The Bristol Stool Form Scale is widely validated and demonstrates high reliability and reproducibility in clinical and research settings.
In this study, it will be used as a primary outcome measure to evaluate changes in bowel habits, either independently or alongside bowel movement frequency.
|
6 weeks
|
|
Patient Assessment of Constipation Quality of Life (PAC-QOL)
Временное ограничение: 6 weeks
|
This questionnaire will be used to evaluate the impact of constipation on patients' daily life, including physical discomfort, psychosocial effects, and overall satisfaction.
The PAC-QOL has excellent psychometric properties, including strong validity and reliability.
In this study, it will be used as a secondary outcome measure to assess improvements in quality of life following the intervention.
|
6 weeks
|
Соавторы и исследователи
Спонсор
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- EA constipation
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. .