Mastodynia
Conditions
Keywords
Breast Pain, Mastalgia, Bras, Breast Support
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.
Interventions
OTHERBra prescription
OTHERStandard Care
Sponsors
Portsmouth Hospitals NHS Trust
University of Portsmouth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) | 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) |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Bra prescription
Standard Care | 10 |
| 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.
Standard Care | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Prescription Group | Total | Standard Care Group |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 9 | 39 years STANDARD_DEVIATION 10 | 32 years STANDARD_DEVIATION 6 |
| Breast Pain | 6 scores on a scale STANDARD_DEVIATION 2 | 6 scores on a scale STANDARD_DEVIATION 2 | 2 scores on a scale STANDARD_DEVIATION 2 |
| Quality of Life (Mental Component Summary) | 45.6 MCS score STANDARD_DEVIATION 9.6 | 45.2 MCS score STANDARD_DEVIATION 9 | 44.8 MCS score STANDARD_DEVIATION 8.8 |
| Quality of Life (Physical Component Summary) | 49.3 scores on a scale STANDARD_DEVIATION 7.4 | 51.8 scores on a scale STANDARD_DEVIATION 7.1 | 55.0 scores on a scale STANDARD_DEVIATION 5.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
Primary
Patient Global Impression of Change (PGIC)
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)
Time frame: four weeks post intervention
Population: Percentage of those who scored Very much improved or much improved in each group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prescription Group | Patient Global Impression of Change (PGIC) | 55 percentage of VMI/MI respondents |
| Standard Care Group | Patient Global Impression of Change (PGIC) | 25 percentage of VMI/MI respondents |
Primary
Patient Global Impression of Change (PGIC)
Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain
Time frame: eight weeks post intervention
Population: Percentage of those scoring very much improved or much improved
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prescription Group | Patient Global Impression of Change (PGIC) | 50 percentage |
| Standard Care Group | Patient Global Impression of Change (PGIC) | 25 percentage |