Auriculotherapy in the Cares to the Premenstrual Syndrome

Auriculotherapy in the Cares to the Premenstrual Syndrome: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Other: Auriculotherapy group

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 44 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Auricular acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Sociedade Hospital Samaritano
• Investigators: Principal Investigator: Leonice FS Kurebayashi, Ms, Sao Paulo University; Study Chair: Rafael FB Homo, University of Sao Paulo; Principal Investigator: Ana LL Giaponesi, Samaritan Hospital; Study Director: Maria JP Silva, Phd, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: January 30, 2013
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (ESTIMATE): February 1, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Behavioral changes; Premenstrual syndrome; Physical distress
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: CEP 35/2010