Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of additional self-care acupressure in women with menstrual pain compared to usual care alone.
详细描述
Menstrual pain is a common problem in young women and one of the the main reasons of short term absence from school or work. There is some evidence that acupuncture and acupressure might be successful in treating of menstrual pain. Compared with acupuncture, acupressure offers the possibility for women with menstrual pain to do self-care treatment at home. However, studies have been small and self-care acupressure had been only investigated in one study from Taiwan.
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with dysmenorrhea as defined as cramping pain during every menstrual cycle
- •Age: 18 to 25 years
- •Up to now no prior history of a gynecological disease that could be a reason for dysmenorrhea
- •Women with menstruation in the last six weeks and a duration of menstruation cycles between 3 and 6 weeks
- •Women with moderate and severe pain defined as a score equal or higher than 6 on the numeric rating scale for the worst pain intensity during the last menstruation.
- •Written and oral informed consent
- •Women must be able to complete the baseline questionnaire in paper form, the electronic questionnaire via App and a electronic diary via App.
- •Presence of a Smartphone and agreement to do data entry through the App
排除标准
- •Acupressure, acupuncture, shiatsu- or/and tuina massage at the moment or planned in the next 8 months
- •Known or planned pregnancy in the next 8 months.
结局指标
主要结局
Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)
时间窗: 3rd menstruation after therapy start
次要结局
- Adverse effects(After 1., 2., 3. and 6. menstruation)
- Bodily self-efficacy(Baseline, after 1.,2.,3. and 6. menstruation)
- Responder rate defined as 50% pain reduction at the days of pain(Baseline, after the 1., 2., 3. and 6. menstruation)
- Worst pain intensity (NRS)(Baseline, after the 1., 2., 3. and 6. menstruation)
- Sick leave days(Baseline, after the 1., 2., 3. and 6. menstruation)
- Days with medication intake(Baseline, after the 1., 2., 3. and 6. menstruation)
- Duration of pain(Baseline, after the 1., 2., 3. and 6. menstruation)
- Credibility of the intervention(After 3. menstruation)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany