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Completed

NCT Number: NCT02515253

A Breast Support Intervention for Women With Breast Pain

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Breast Care Services, Queen Alexandra Hospital, Portsmouth, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bra prescription

Other

Standard care

Other

Primary outcomes

  1. 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

    • = Very much improved (better outcome)
    • = Much improved
    • = Minimally improved
    • = No change
    • = Minimally worse
    • = Much worse
    • = Very much worse (worse outcome)
  2. 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

Sponsors and collaborators

Lead sponsor

University of Portsmouth

Other

Collaborators

  • Portsmouth Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2015
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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