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NCT Number: NCT03148223

Auriculotherapy in the Treatment of Dysmenorrhea

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.

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Key information

Conditions

Primary Dysmenorrhea Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de Sorocaba - Campus Cidade Universitária

Sorocaba, São Paulo, 18023-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

auriculotherapy

Device

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.

Other names: acupuncture

Primary outcomes

  1. Measurement on pain perception

    Time frame: 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 outcomes

  1. Welfare

    Time frame: 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.

  2. Number of participants with adverse events

    Time frame: 12 weeks

    Adverse events will be collected spontaneously by the active survey, at all visits of participants.

Sponsors and collaborators

Lead sponsor

University of Sorocaba

Other

Registry information

Official study title

Effect of Auriculotherapy in the Treatment of Dysmenorrhea: Protocol of a Randomized Controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 10, 2017
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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