A Randomised Control Trial of an Individual Bra Prescription Versus Standard Care for Women With Larger Breasts and Breast Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Portsmouth
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Patient Global Impression of Change (PGIC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: Standard Care (Other)
Outcomes
Primary Outcomes
Patient Global Impression of Change (PGIC)
Time Frame: eight weeks post intervention
Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain
Patient Global Impression of Change (PGIC)
Time Frame: four weeks post intervention
Participants will complete the PGIC as part of a questionnaire four weeks after receiving their treatment for benign breast pain 1. = Very much improved (better outcome) 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse (worse outcome)
Secondary Outcomes
No secondary outcomes reported
Investigators
Emma Burnett
PhD Research Student
University of Portsmouth