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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20160392H | Other Identifier | University of Texas Health Science Center- San Antonio |
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To determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram.
The study is designed to evaluate two methods of reducing pain and anxiety caused by mammography, one of the barriers to the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right Breast Lidocaine and calming music | Experimental | Group 1 - right breast lidocaine & calming music |
|
| Right Breast Lidocaine and no music | Experimental | Group 2 - right breast lidocaine & no calming music |
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| Left Breast Lidocaine and calming music | Experimental | Group 3 - left breast lidocaine & calming music |
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| Left Breast Lidocaine and no music | Experimental | Group 4 - left breast lidocaine & no calming music |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Other | Applied to breast skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire to determine the change (or difference) in pain level before and after mammogram | The questionnaires will be typically be completed about 60 minutes apart. The first questionnaire will be completed before any intervention. The second questionnaire will be administered at the earliest at about 35 minutes later (after application of the gels and performance of mammography). The longest interval between administration of the questionnaires would be 75 minutes (after which time the gel must be removed, per protocol). | The questionnaires are completed before and after mammography, on the same day (questionnaire will be completed before leaving the mammography clinic the day of mammography). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Kist, MD | CTRC @ UTHSCSA | Principal Investigator |
| Virginia Kaklamani, MD | CTRC @ UTHSCSA | Study Chair |
| Pamela Otto, MD | CTRC @ UTHSCSA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health Cancer Center | San Antonio | Texas | 78260 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Calming Music | Other | Played during mammography |
|
| No Music | Other | No music played during mammography |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |