A Breast Support Intervention for Women With Breast Pain

Mastodynia Clinical Trial

Official title:

A Randomised Control Trial of an Individual Bra Prescription Versus Standard Care for Women With Larger Breasts and Breast Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515253
• Other study ID #: BP-01
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2019
• Source: University of Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Mastodynia

Intervention

Other:
• Bra prescription

• Standard Care

Locations

Country	Name	City	State
United Kingdom	Breast Care Services, Queen Alexandra Hospital	Portsmouth
United Kingdom	Department of Sport and Exercise Science, University of Portsmouth	Portsmouth

Sponsors (2)

Lead Sponsor	Collaborator
University of Portsmouth	Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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; = Very much improved (better outcome); = Much improved; = Minimally improved; = No change; = Minimally worse; = Much worse; = Very much worse (worse outcome)	four weeks post intervention
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	eight weeks post intervention