Auriculotherapy in the Treatment of Dysmenorrhea

University of Sorocaba

Status: Completed

Conditions: Primary Dysmenorrhea

Treatments: Device: auriculotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03148223

45269015.3.0000.5500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Device: auriculotherapy

Control

Placebo Comparator group

Description:

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.

Treatment:

Device: auriculotherapy