Primary Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, acupuncture, auriculotherapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEauriculotherapy
The participants will be submitted to a session per week with duration of 20 minutes, for three consecutive months, to fix the adhesives. The points selected for stimulation, according to Chinese atrial mapping, are: uterus, endocrine, ovary, pituitary, shen men, sympathetic, and liver. Participants will be advised to remain with the stickers fixed to the auricle for six days.
Sponsors
University of Sorocaba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* An individual who meets any of the following criteria will be excluded from participation in this study: * Clinical diagnosis of endometriosis * Myomas * Pelvic inflammatory disease * Adenomyosis * In the active phase for treatment of cancer (chemotherapy or radiotherapy) * Women who are already in menopause * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement on pain perception | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Welfare | 12 weeks | The quality of life questionnaire (Short-Form Health Survey SF36) will be applied at the beginning of the intervention period and reapplied at the end of the 12 weeks of intervention. |
| Number of participants with adverse events | 12 weeks | Adverse events will be collected spontaneously by the active survey, at all visits of participants. |
Countries
Brazil
Outcome results
None listed