Auriculotherapy in the Cares to the Premenstrual Syndrome

NCT01782040 | Completed Phase 2 DMC

• 1 other identifier: CEP 35/2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual syndrome; Physical distress; Behavioral changes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

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

Auriculotherapy group

EXPERIMENTAL

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

Interventions

Auriculotherapy group OTHER

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

Also known as: Auricular acupuncture

Auriculotherapy group

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Sociedade Hospital Samaritano: collaborator

Study Sites (1)

Samaritan Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Leonice FS Kurebayashi, Ms

  São Paulo University

  PRINCIPAL INVESTIGATOR

• Rafael FB Homo

  University of Sao Paulo

  STUDY CHAIR

• Ana LL Giaponesi

  Samaritan Hospital

  PRINCIPAL INVESTIGATOR

• Maria JP Silva, Phd

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leonice Fumiko Sato Kurebayashi

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2012
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

BR (1)