Auriculotherapy in the Cares to the Premenstrual Syndrome

NCT ID: NCT01782040

Last Updated: 2013-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Premenstrual Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Control Group didn't receive any treatment and it was evaluated at the same time and the same way of interventions group

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Auriculotherapy group

Intervention Type OTHER

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

Interventions

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Auriculotherapy group

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

Intervention Type OTHER

Other Intervention Names

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Auricular acupuncture

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sociedade Hospital Samaritano

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Leonice Fumiko Sato Kurebayashi

Leonice Fumiko Sato Kurebayashi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonice FS Kurebayashi, Ms

Role: PRINCIPAL_INVESTIGATOR

São Paulo University

Rafael FB Homo

Role: STUDY_CHAIR

University of Sao Paulo

Ana LL Giaponesi

Role: PRINCIPAL_INVESTIGATOR

Samaritan Hospital

Maria JP Silva, Phd

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Samaritan Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP 35/2010

Identifier Type: -

Identifier Source: org_study_id

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