Sexuality After 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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty|
- Sexual function [ Time Frame: 6 months ] [ Designated as safety issue: No ]Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
- depression predictors [ Time Frame: 6 months ] [ Designated as safety issue: No ]Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.
|Study Start Date:||July 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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 Name: Breast reduction
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020422
|Hospital das Clínicas Samuel Libânio - UNIVÁS|
|Pouso Alegre, Minas Gerais, Brazil, 37550000|
|Principal Investigator:||Flavia N Beraldo, MSC||UNIFESP and UNIVAS|
|Study Director:||Daniela F Veiga, MD, PhD||UNIFESP and UNIVAS|
|Study Chair:||Lydia M Ferreira, MD, PhD||Federal University of São Paulo|