Effect of Acupressure in The Management of Postmenopausal Constipation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient Assessment of Constipation Symptom (PAC - SYM)
研究概览
简要总结
This study was conducted to investigate the effect of acupressure in the management of constipation in postmenopausal women.
详细描述
Constipation is prevalent in menopause, affecting 4-29% of women globally, and can lead to serious complications like hemorrhoids, anal fissures, and colorectal cancer. While laxatives can help, long-term use may cause dependency and side effects. Alternative therapies are needed.
Deep breathing, particularly diaphragmatic breathing, may improve constipation by activating the parasympathetic system and promoting relaxation. Acupressure has also shown potential in managing constipation by stimulating intestinal activity, improving blood circulation, and regulating Qi flow.
Despite existing studies on acupressure and constipation, no research has specifically examined its effect on postmenopausal women. This study aims to investigate acupressure's impact on functional constipation in this population, offering potential insights for non-pharmacological management.
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)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sixty postmenopausal women who were clinically diagnosed as having functional constipation after menopause (at least one year after the stoppage of the last menstrual cycle)
- •Their ages ranged from 50 to 60 years old.
- •Their body mass index didn't exceed 30 kg/m
- •All of them should have at least two criteria of Rome III diagnostic criteria of constipation.
- •They should stop laxatives intake during the treatment program.
排除标准
- •Irritable bowel syndrome or anal fissures.
- •Genital organ prolapse as rectocele.
- •Any neurological diseases, spinal diseases or spinal deformities.
- •History of bowel surgery.
- •Congenital anorectal malformation, stoma in situ.
- •Diabetes mellitus and sever distal venous insufficiency.
- •Skin eruption at the site of stimulation.
- •Implanted pacemaker or defibrillator.
- •Metalic implant in lower limb.
- •Recent surgery at the lower limb.
- •Peripheral neuropathy and neurological disorders.
- •Psychological distress.
研究组 & 干预措施
acupressure + diaphragmatic breathing exercises + general bowel care advise
It consisted of 30 postmenopausal women. Each of them received acupressure on the (san jio 6/ stomach 25/ spleen 15/ joining vally " large intestine 4 ") acupoints, 1 minute for each point with 3 repetitions on both sides (about 30 minutes as total time), 3 times per week in addition to diaphragmatic breathing exercises for 15 minutes and general bowel care advise, for 6 weeks.
干预措施: Acupressure (Other)
acupressure + diaphragmatic breathing exercises + general bowel care advise
It consisted of 30 postmenopausal women. Each of them received acupressure on the (san jio 6/ stomach 25/ spleen 15/ joining vally " large intestine 4 ") acupoints, 1 minute for each point with 3 repetitions on both sides (about 30 minutes as total time), 3 times per week in addition to diaphragmatic breathing exercises for 15 minutes and general bowel care advise, for 6 weeks.
干预措施: Diaphragmatic breathing exercises (Other)
acupressure + diaphragmatic breathing exercises + general bowel care advise
It consisted of 30 postmenopausal women. Each of them received acupressure on the (san jio 6/ stomach 25/ spleen 15/ joining vally " large intestine 4 ") acupoints, 1 minute for each point with 3 repetitions on both sides (about 30 minutes as total time), 3 times per week in addition to diaphragmatic breathing exercises for 15 minutes and general bowel care advise, for 6 weeks.
干预措施: General bowel care advise (Other)
diaphragmatic breathing exercises + general bowel care advise
It consisted of 30 postmenopausal women who performed diaphragmatic breathing exercises for 15 minutes 3 times per week in addition to general bowel care advice only, for 6 weeks.
干预措施: Diaphragmatic breathing exercises (Other)
diaphragmatic breathing exercises + general bowel care advise
It consisted of 30 postmenopausal women who performed diaphragmatic breathing exercises for 15 minutes 3 times per week in addition to general bowel care advice only, for 6 weeks.
干预措施: General bowel care advise (Other)
结局指标
主要结局
Patient Assessment of Constipation Symptom (PAC - SYM)
时间窗: 6 weeks
It is a reliable and valid tool to measure the patient's perspective constipation symptoms in terms of frequency and severity, It is a 12- item that is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Like scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
Patient Assessment of Constipation quality of life (PAC - QOL)
时间窗: 6 weeks
The PAC-QOL questionnaire is used to evaluate the quality of life of patients having constipation. It is a brief but comprehensive tool which evaluates constipation through daily individual health assessment and functioning. This questionnaire consists of 28 self-reported items which sub-categorized to 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Lower scores indicate higher quality of life.
次要结局
未报告次要终点
研究者
Samar Gamal Mohamed Gab Allah
Principal Investigator
Cairo University