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Auriculotherapy in the Cares to the Premenstrual Syndrome

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Auriculotherapy group
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Premenstrual syndrome, Physical distress, Behavioral changes

Eligibility Criteria

21 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Samaritan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Auriculotherapy group

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 30, 2013
Last Updated
January 30, 2013
Sponsor
University of Sao Paulo
Collaborators
Sociedade Hospital Samaritano
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1. Study Identification

Unique Protocol Identification Number
NCT01782040
Brief Title
Auriculotherapy in the Cares to the Premenstrual Syndrome
Official Title
Auriculotherapy in the Cares to the Premenstrual Syndrome: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Sociedade Hospital Samaritano

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual syndrome, Physical distress, Behavioral changes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group didn't receive any treatment and it was evaluated at the same time and the same way of interventions group
Arm Title
Auriculotherapy group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Auriculotherapy group
Other Intervention Name(s)
Auricular acupuncture
Intervention Description
It was used semipermanent needles (1.5mm) to stimulate points, once on a week, during 8 sessions.
Primary Outcome Measure Information:
Title
Premenstrual syndrome symptoms
Description
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)
Time Frame
after 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonice FS Kurebayashi, Ms
Organizational Affiliation
São Paulo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafael FB Homo
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ana LL Giaponesi
Organizational Affiliation
Samaritan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria JP Silva, Phd
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Samaritan Hospital
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

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Auriculotherapy in the Cares to the Premenstrual Syndrome

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