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临床试验/NCT02864186
NCT02864186
已完成
不适用

A Randomized Study to Test the Hypothesis That a Support Bra Will Improve Healing and Quality of Life After Coronary Artery By-Pass Graft (CABG)

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 190 人2015年1月26日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Quality of Life
发起方
University of Sao Paulo
入组人数
190
试验地点
1
主要终点
Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical
状态
已完成
最后更新
5年前

概览

简要总结

That study have the primary purpose identify if exist difference to the healing and quality of life between women that use of a surgical support bra, common support bra and without support bra after coronary artery bypass graft surgery.

To do this, will be assessed pain, healing of the wound (dehiscence, infection) and quality of life life through specific instruments.

详细描述

The patients will be randomized and share into three groups: women after coronary artery bypass surgery use surgical support bra, women after coronary artery bypass surgery use common support bra and those who will not use any support bra. They will be can tracked and invited to participate in the study few days before the surgery or during the post operatory (2 - 6 days after surgery). The assessement and the intervention must be start in the inpatient unit from the 2nd to 6th post operatory until their discharge. Initially, it will be apply a questionnaire of quality of life (SF36) to assess the quality of life before the surgical procedure. In this moment, will be measured for breast size and also wil be identify the risk factors through a brief historical. During the stay in the hospital, the patients will be assessed on a daily basis with respect to the following: pain (verbal numerical scale) and wound appearance. The questionnaire of quality of life(SF36) will be applied again for more three times, about one month, two months and six months after the discharge together with the assessement to the pain and wound healing.

注册库
clinicaltrials.gov
开始日期
2015年1月26日
结束日期
2018年8月30日
最后更新
5年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Luiz Antonio M. Cesar

Associated Professor of Cardiology

University of Sao Paulo

入排标准

入选标准

  • Women who undergoing coronary artery bypass graft surgery
  • Women who signed the term consent and informed

排除标准

  • Women who have had any breast surgery
  • Women who undergoing radiotherapy to the thorax.
  • Women with cognitive impairments.

结局指标

主要结局

Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical

时间窗: at six months after surgery

次要结局

  • Quality of Life pre cardiac surgery - SF36(one day before surgery and then at one, two and six months)
  • Sternal Wound Dehiscence - Medical Documentation or Nursing in the Medical Records(at six months after surgery)
  • Use of antibiotics and painkillers - Medical Prescription(at six months after surgery.)

研究点 (1)

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