A Study Attempting to Improve the Comfort During Screening Mammography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Questionnaire to determine the change (or difference) in pain level before and after mammogram
研究概览
简要总结
To determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram.
详细描述
The study is designed to evaluate two methods of reducing pain and anxiety caused by mammography, one of the barriers to the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain.
- •Must have two breasts
排除标准
- •May not have taken ibuprofen or other pain medication within the Space last 12 hours (ASA 81 mg dose is allowed).
- •Must not have a contraindication for using lidocaine: e.g no history of allergic reactions to lidocaine.
- •Must not have had history of breast cancer, breast surgery, radiation to the chest wall.
- •Must not have broken or irritated skin (as determined by the study nurses).
- •May not be lactating or breast feeding
结局指标
主要结局
Questionnaire to determine the change (or difference) in pain level before and after mammogram
时间窗: The questionnaires are completed before and after mammography, on the same day (questionnaire will be completed before leaving the mammography clinic the day of mammography).
The questionnaires will be typically be completed about 60 minutes apart. The first questionnaire will be completed before any intervention. The second questionnaire will be administered at the earliest at about 35 minutes later (after application of the gels and performance of mammography). The longest interval between administration of the questionnaires would be 75 minutes (after which time the gel must be removed, per protocol).
次要结局
未报告次要终点