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Набор скоро начнётся NCT07572786

Effect of Electroacupuncture on Bowel Function and Quality of Life in Postpartum Constipation: A Randomized Controlled Trial

Без фазы С лечением Postpartum Constipation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: electroacupuncture, abdominal exercises for constipation.
Кому может быть актуально
Состояния в реестре: Postpartum Constipation. Базовые параметры: 20 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Postpartum constipation is a common condition affecting women after childbirth, leading to discomfort and reduced quality of life. Pharmacological treatments may have side effects and are sometimes avoided during breastfeeding. Electroacupuncture is a safe, non-pharmacological intervention that may improve bowel motility. However, limited evidence exists regarding its effectiveness in postpartum women, necessitating further investigation

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:

1. 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. 2. 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.

Вмешательства

  • Другое electroacupuncture
    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 co
  • Другое abdominal exercises for constipation
    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

Первичные конечные точки

  • Bristol Stool Form Scale [Срок оценки: 6 weeks]
  • Patient Assessment of Constipation Quality of Life (PAC-QOL) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • Females aged 20-40 years
  • Within 6 weeks postpartum
  • Diagnosed with constipation
  • Willing to participate

Критерии исключения

  • History of gastrointestinal disorders
  • Previous colorectal surgery
  • Neurological diseases affecting bowel function
  • Contraindications to acupuncture (tumor, scar or keloids \& spinal instability ).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07572786 · EA constipation

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗