A Breast Support Intervention for Women With Breast Pain
Not Applicable
Completed
- Conditions
- Mastodynia
- Registration Number
- NCT02515253
- Lead Sponsor
- University of Portsmouth
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 33
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) eight weeks post intervention Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Department of Sport and Exercise Science, University of Portsmouth
🇬🇧Portsmouth, United Kingdom
Breast Care Services, Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Department of Sport and Exercise Science, University of Portsmouth🇬🇧Portsmouth, United Kingdom