Auriculotherapy in the Treatment of Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Device: auriculotherapy

• Registration Number: NCT03148223
• Lead Sponsor: University of Sorocaba

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.

Study Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Study Start: 2017-05-15
• Primary Completion: 2018-08-30
• Status Verified: 2018-10
• Study Completion: 2018-10-15
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	auriculotherapy	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.
Control	auriculotherapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Universidade de Sorocaba - Campus Cidade Universitária; 🇧🇷 Sorocaba, São Paulo, Brazil