A Randomised Control Trial of an Individual Bra Prescription Versus Standard Care for Women With Larger Breasts and Breast Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Patient Global Impression of Change (PGIC)
研究概览
简要总结
The purpose of this study is to assess whether prescribing a bra to participants results in an improvement in the Patient Global Impression of Change (PGIC) compared to participants who receive standard care alone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18 years of age and above.
- •Experiencing breast pain of any severity.
- •Participants must be able to speak and read English fluently
- •Participants must be a resident within the local area and not planning to move out of the area within the study timeline
- •Participant must have attended the Queen Alexandra (QA) hospital for an assessment of their breast pain.
- •Participant is willing and able to give informed consent for participation in the study.
- •Participant is self-reported to be between a 34 and 40 under band size and a DD to G bra cup size.
- •Able to walk on a treadmill for up to two minutes unaided and be able to walk unaided up and down a small set of steps (assessed verbally by the clinicians at QA hospital)
- •Participants must be able to comply with the study procedures
排除标准
- •Participants are receiving any additional treatment for their breast pain that is not part of standard care (recommendation for a bra fit, topical ibuprofen, breast pain leaflet) including any cancer treatment
- •Participants have had any surgery to the breasts within the last year
- •Participants are currently pregnant or have been pregnant or breast fed in the past year
- •Planning to undertake any activities or lifestyle changes which may affect their levels of breast pain e.g. trying for a baby, changing oral contraceptive, having breast surgery.
- •Participant's data will be excluded from the analysis if they do not complete either survey at four or eight weeks (at least one follow up survey needs to be completed).
研究组 & 干预措施
Prescription group
Participants in this group will receive the standard care for benign breast pain sufferers (administered by the Queen Alexandra Hospital in Portsmouth) and will also attend the Department of Sport and Exercise Science at the University of Portsmouth for an individual bra prescription. Participants will be prescribed an appropriate bra to wear over an eight week intervention period.
干预措施: Bra prescription (Other)
Prescription group
Participants in this group will receive the standard care for benign breast pain sufferers (administered by the Queen Alexandra Hospital in Portsmouth) and will also attend the Department of Sport and Exercise Science at the University of Portsmouth for an individual bra prescription. Participants will be prescribed an appropriate bra to wear over an eight week intervention period.
干预措施: Standard Care (Other)
Standard care group
Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.
干预措施: Standard Care (Other)
结局指标
主要结局
Patient Global Impression of Change (PGIC)
时间窗: eight weeks post intervention
Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain
次要结局
未报告次要终点
研究者
Emma Burnett
PhD Research Student
University of Portsmouth