Effect of Auriculotherapy in the Treatment of Dysmenorrhea: Protocol of a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Measurement on pain perception
研究概览
简要总结
This study aims to determine if auriculotherapy is effective in the treatment of dysmenorrhoea. This intervention consists of fixation of yellow mustard seeds at specific points of the auricular pavilion (or area), with opaque tape. Half of the participants will have specific ear pinch points stimulated by mustard seeds fixed with opaque plaster, while the other half will have only the adhesive plasters fixed, without the seeds for stimulation.
详细描述
Primary dysmenorrhoea is responsible for the most part of dissatisfactions in the female class, in the face of discomforts which are caused monthly. For this, the income index of this woman in the work environment tends to reduce, thus harming the development of every sector to which she responds. The expected effects, after the intervention, will be positive, favoring a considerable improvement of the symptoms reported by the women. We chose auriculotherapy because it is a non-medicated, noninvasive intervention that is inexpensive.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will not be informed which group they belong to, intervention or control. Who will apply the treatment will not be blind, since during the treatment it will know if the points to be stimulated must contain seeds of mustard or just plaster, but will not have previous knowledge of the members of the groups. The evaluator, who is responsible for applying the pre- and post-treatment evaluation instruments, will be blind and not aware of the research intervention. The data analyst will also be early for the intervention group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, the individual must meet the following criteria:
- •Free and informed consent form, duly signed and dated
- •Consent to voluntarily participate in all study procedures and availability for the duration of the study
- •Female subjects
- •Age above of 18 years old
- •Enjoy good general health
- •Have active menstrual cycle
- •Complaint about dysmenorrhea
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Clinical diagnosis of endometriosis
- •Pelvic inflammatory disease
- •Adenomyosis
- •In the active phase for treatment of cancer (chemotherapy or radiotherapy)
- •Women who are already in menopause
- •Pregnancy
研究组 & 干预措施
Intervention
Auriculotherapy with application of mustard seeds fixed with adhesive tape at specific points in the auricle during one session per week lasting 20 minutes for 3 consecutive months.
干预措施: auriculotherapy (Device)
Control
Auriculotherapy with tape-only fixation in the auricle, without mustard seeds, following the same stitch protocol used with the intervention group, during a session per week lasting 20 minutes, for three consecutive months.
干预措施: auriculotherapy (Device)
结局指标
主要结局
Measurement on pain perception
时间窗: 12 weeks
The numerical visual scale of pain 0-10 (0 = no pain, 10 = worst possible pain), applied at the beginning of the intervention period and reapplied to each menstrual period during the 12 weeks of follow-up will be used.
次要结局
- Welfare(12 weeks)
- Number of participants with adverse events(12 weeks)
研究者
Luciane Cruz Lopes
Responsible researcher
University of Sorocaba