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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Pain - Visual Numeric Scale - Medical Documentation or Nursing in the Medical
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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.)
研究者
Luiz Antonio M. Cesar
Associated Professor of Cardiology
University of Sao Paulo