Auriculotherapy in the Cares to the Premenstrual Syndrome

Premenstrual Syndrome Clinical Trial

Official title:

Auriculotherapy in the Cares to the Premenstrual Syndrome: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782040
• Other study ID #: CEP 35/2010
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2013
• Last updated: January 30, 2013
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a woman's menstrual cycle. These symptoms occurring only during the luteal phase of the menstrual cycle that are of sufficient severity to interfere with some aspects of life of these women, reflecting also in interpersonal relationships, workplace and in their productivity. For these reasons, this research was conducted with the nursing staff of the Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to alleviate some of the symptoms of PMS.

Description:

The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semipermanent needles in specific points of the auricular pavilion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 44 Years

Eligibility

Inclusion Criteria:

1. Belong to the nursing staff

2. Present at least one behavioral or physical symptom that is self-perceived as related to the symptoms that precede menstruation (irritability, depression, fatigue, headache, breast tenderness, swelling, anxiety, insomnia, crying spells, changes in appetite)

3. Voluntary participation in the study

4. Availability of time for submission to the sessions

Exclusion Criteria:

1. Medical license or vacation during the period of the research.

2. Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Auriculotherapy group
It was used semipermanent needles (1.5mm) to stimulate points, once on a week, during 8 sessions.

Locations

Country	Name	City	State
Brazil	Samaritan Hospital	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Sociedade Hospital Samaritano

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premenstrual syndrome symptoms	This randomized clinical trial aimed at evaluating the auriculotherapy efficacy to reduce behavioral or physical symptom that is self-perceived as related to the symptoms that precede menstruation (irritability, depression, fatigue, headache, breast tenderness, swelling, anxiety, insomnia, crying spells, changes in appetite)	after 3 months	Yes