Sexuality After Reduction Mammaplasty

September 3, 2019 updated by: Daniela Francescato Veiga

Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty

The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast hypertrophy is a common condition among women. Reduction mammaplasty is an effective and well established procedure performed for the relief discomfort associated with breast hypertrophy. Female breasts play an important role in sexuality, thus, the main purpose of this study is to determine whether reduction mammaplasty could influence sexual function and depression predictors on women with breast hypertrophy.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37550000
        • Hospital das Clínicas Samuel Libânio - UNIVÁS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • breast hypertrophy
  • candidate to reduction mammaplasty
  • healthy volunteer with normal volume breasts (control group)
  • body mass index under 30Kg/m2

Exclusion Criteria:

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • hard smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Breast hypertrophy
Patients with macromastia will be evaluated in regard to sexual function and depression predictors at 3 moments: initial interview, after 3 months and after 6 months
Experimental: Reduction Mammaplasty
Breast hypertrophy patients randomized to this group will immediately be scheduled for reduction mammaplasty and will be will be evaluated in regard to sexual function and depression predictors preoperatively and 3 and 6 months postoperatively
Procedure: Reduction mammaplasty
Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
Other Names:
  • Breast reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual function
Time Frame: 6 months
Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression predictors
Time Frame: 6 months
Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Francescato Veiga

Collaborators

Universidade do Vale do Sapucai

Investigators

  • Study Chair: Lydia M Ferreira, MD, PhD, Federal University of São Paulo
  • Principal Investigator: Flavia N Beraldo, PhD, UNIFESP and UNIVAS
  • Study Director: Daniela F Veiga, MD, PhD, UNIFESP and UNIVAS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dinter 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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