Effect of Electroacupuncture on Bowel Function and Quality of Life in Postpartum Constipation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Bristol Stool Form Scale
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study is assessor-blinded. The individual responsible for outcome evaluation will not be informed of group allocation. Participants and therapists delivering the interventions will be aware of the assigned treatment due to the practical limitations of the study design.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 20-40 years
- •Within 6 weeks postpartum
- •Diagnosed with constipation
- •Willing to participate
排除标准
- •History of gastrointestinal disorders
- •Previous colorectal surgery
- •Neurological diseases affecting bowel function
- •Contraindications to acupuncture (tumor, scar or keloids & spinal instability ).
研究组 & 干预措施
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.
干预措施: abdominal exercises for constipation (Other)
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.
干预措施: electroacupuncture (Other)
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].
干预措施: abdominal exercises for constipation (Other)
结局指标
主要结局
Bristol Stool Form Scale
时间窗: 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.
Patient Assessment of Constipation Quality of Life (PAC-QOL)
时间窗: 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.
次要结局
未报告次要终点
研究者
shaimaa Mohamed hamed
Lecturer
MTI University