Auriculotherapy in the Cares to the Premenstrual Syndrome

This study has been completed.

Sponsor:

Collaborator:

Sociedade Hospital Samaritano

Information provided by (Responsible Party):

Leonice Fumiko Sato Kurebayashi, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01782040

First received: January 30, 2013

Last updated: NA

Last verified: January 2013

History: No changes posted

Purpose

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.

Condition	Intervention	Phase
Premenstrual Syndrome	Other: Auriculotherapy group	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Auriculotherapy in the Cares to the Premenstrual Syndrome: Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Menstruation Premenstrual Syndrome

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Premenstrual syndrome symptoms [ Time Frame: after 3 months ] [ Designated as safety issue: Yes ]
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)

Enrollment:	40
Study Start Date:	January 2011
Study Completion Date:	July 2012
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control Group Control Group didn't receive any treatment and it was evaluated at the same time and the same way of interventions group
Experimental: Auriculotherapy group The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.It was used 6 points: Kidney, Liver, Stomach, Brain Stem, Ovary and Uterus point with semi-permanent needles one time per week for 8 sessions	Other: Auriculotherapy group It was used semipermanent needles (1.5mm) to stimulate points, once on a week, during 8 sessions. Other Name: Auricular acupuncture

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years to 44 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Belong to the nursing staff
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)
Voluntary participation in the study
Availability of time for submission to the sessions

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782040

Locations

Brazil
Samaritan Hospital
São Paulo, Brazil

Sponsors and Collaborators

University of Sao Paulo

Sociedade Hospital Samaritano

Investigators

Principal Investigator:	Leonice FS Kurebayashi, Ms	São Paulo University
Study Chair:	Rafael FB Homo	University of São Paulo
Principal Investigator:	Ana LL Giaponesi	Samaritan Hospital
Study Director:	Maria JP Silva, Phd	University of São Paulo

More Information

No publications provided

Responsible Party:	Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01782040 History of Changes
Other Study ID Numbers:	CEP 35/2010
Study First Received:	January 30, 2013
Last Updated:	January 30, 2013
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

Premenstrual syndrome
Physical distress
Behavioral changes

Additional relevant MeSH terms:

Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013

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