An interventional study of Bra prescription and Standard Care in Mastodynia, sponsored by University of Portsmouth. Completed at 2 sites in United Kingdom. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by University of Portsmouth · Not applicable, Interventional, and Supportive care
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.
44 studies on the registry are indexed under Mastodynia; 10 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 37 interventional studies indexed under Mastodynia.
Browse Mastodynia studies →University of Portsmouth is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Bra prescription · Other: Standard Care
Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.
Other: Standard Care
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
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
| Milestone | Prescription Group | Standard Care Group |
|---|---|---|
| Started | 17 | 16 |
| Completed | 10 | 8 |
| Not completed | 7 | 8 |
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)
| percentage of VMI/MI respondents | Prescription Group | Standard Care Group |
|---|---|---|
| Patient Global Impression of Change (PGIC) | 55 | 25 |
Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain
| percentage | Prescription Group | Standard Care Group |
|---|---|---|
| Patient Global Impression of Change (PGIC) | 50 | 25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prescription Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Standard Care Group | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Prescription Group | Standard Care Group | Total |
|---|---|---|---|
| Mean | 45 ± 9 | 32 ± 6 | 39 ± 10 |
| Sex: Female, Male(Participants) | Prescription Group | Standard Care Group | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Prescription Group | Standard Care Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Breast Pain(scores on a scale) | Prescription Group | Standard Care Group | Total |
|---|---|---|---|
| Median | 6 ± 2 | 2 ± 2 | 6 ± 2 |
| Quality of Life (Physical Component Summary)(scores on a scale) | Prescription Group | Standard Care Group | Total |
|---|---|---|---|
| Mean | 49.3 ± 7.4 | 55.0 ± 5.7 | 51.8 ± 7.1 |
| Quality of Life (Mental Component Summary)(MCS score) | Prescription Group | Standard Care Group | Total |
|---|---|---|---|
| Mean | 45.6 ± 9.6 | 44.8 ± 8.8 | 45.2 ± 9.0 |
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of Portsmouth