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临床试验/NCT01020422
NCT01020422已完成不适用

Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty

Daniela Francescato Veiga2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Sexual function

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Breast hypertrophy

No Intervention

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

Reduction Mammaplasty

Experimental

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

干预措施: Reduction mammaplasty (Procedure)

结局指标

主要结局

Sexual function

时间窗: 6 months

Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.

次要结局

  • depression predictors(6 months)

研究者

发起方
Daniela Francescato Veiga
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniela Francescato Veiga

Professor

Federal University of São Paulo

研究点 (2)

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