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| Name | Class |
|---|---|
| Portsmouth Hospitals NHS Trust | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescription group | Experimental | 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. |
|
| Standard care group | Other | Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bra prescription | Other |
| ||
| Standard Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| four weeks post intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Burnett, MRes | University of Portsmouth | Principal Investigator |
| Joanna Scurr, PhD | University of Portsmouth | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Sport and Exercise Science, University of Portsmouth | Portsmouth | PO1 2ER | United Kingdom | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
| Percentage of those who scored "Very much improved" or "much improved" in each group | Posted | Number | percentage of VMI/MI respondents | four weeks post intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Emma Sharland | University of Portsmouth | emma.sharland@port.ac.uk |
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| ID | Term |
|---|---|
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Breast Care Services, Queen Alexandra Hospital |
| Portsmouth |
| PO6 3LY |
| United Kingdom |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Breast Pain | Numerical rating scale 0 = No pain 10 = Worst possible pain | Median | Standard Deviation | scores on a scale |
|
| Quality of Life (Physical Component Summary) | 0-100 scale 0 = maximum effect on the physical component of quality of life 100 = no effect on the physical component of quality of life | Mean | Standard Deviation | scores on a scale |
|
| Quality of Life (Mental Component Summary) | 0-100 scale 0 = maximum effect on mental component of quality of life 100 = no effect on mental component of quality of life | Mean | Standard Deviation | MCS score |
|
| OG001 | 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 |
|
|
| 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 | Percentage of those scoring "very much improved" or "much improved" | Posted | Number | percentage | eight weeks post intervention |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
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