N/A
N=33
A Breast Support Intervention for Women With Breast Pain
Mastodynia
Bottom Line
View on ClinicalTrials.gov: NCT02515253 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Patient Global Impression of Change (PGIC) — 55; 25 percentage of VMI/MI respondents
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bra prescription (Other); Standard Care (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Portsmouth
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Global Impression of Change (PGIC) |
50; 25 | — |
| PRIMARY Patient Global Impression of Change (PGIC) |
50; 25 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02515253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.