Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Pain - Patient questionnaire
研究概览
简要总结
The primary purpose of this study is to examine whether a properly fitted support bra on females improves their quality of life post-sternotomy. Specifically, does a support bra reduce discomfort, pain and wound dehiscence.
详细描述
Participants will be randomized to one arm of the study. One group will be fitted for a support bra and will be asked to wear this bra 24 hours a day for their 6 week post-course. They will submit to 3 questionnaires (at hospital discharge, at 3 weeks post-op and at their 6 week post-op visit with their surgeon. They will diary over this 6 week period re: pain, comfort, wound healing. The group in the no bra arm will also be measured for breast size and will submit to 3 questionnaires (at the same intervals) and will be asked to diary over their 6 week post-op course re: pain, comfort, wound healing. Chronic pain and quality of life markers will be assessed through a 6month and 1 year follow-up telephone call and questionnaire.
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
- •Adult women (≥ 18 yrs) who are undergoing cardiac surgery with a sternotomy
排除标准
- •Patients who have had a previous mastectomy
- •Previous radiotherapy to the chest
- •Patients who do not read, write or have issues comprehending English
- •Patients with cognitive impairments who will not be able to comply with the research study protocol
- •Patients requiring physical restraints
- •Patients requiring the application of a sternal binder
研究组 & 干预措施
Medical Support Bra
ClearPoint Medical Support Bra worn by patients during their post-cardiac surgery hospital stay (approximately 5-7days).
干预措施: Adjustable Support Bra (Device)
Control
Usual Care
结局指标
主要结局
Pain - Patient questionnaire
时间窗: 1 year after surgery
Pain - Visual Analog Scale
时间窗: 6 weeks
6-week post-op visit
Pain - Pt questionnaire
时间窗: 6 months after surgery
次要结局
- Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale(1 year)
- Comfort - Patient Questionaires(1-year)
- Sternal Wound Dehiscence - Medical Documentation in chart(In hospital post-operative period (approximately 5-7days).)
- Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale(6 months)
- Quality of life post cardiac surgery - SF12(1 year)
- Quality of life pre cardiac surgery - SF12(Pre-op)
- Quality of life pre cardiac surgery - Lawton ADL (Activity of daily living) scale(Pre-op)