Trial record 3 of 17 for:    Premenstrual Syndrome: Clinical Trials

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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Disease
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014