Women's Mammography Study to Improve Comfort During Mammography
NCT ID: NCT02924441
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
251 participants
INTERVENTIONAL
2016-10-01
2022-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Right Breast Lidocaine and calming music
Group 1 - right breast lidocaine \& calming music
Lidocaine
Applied to breast skin
Calming Music
Played during mammography
Right Breast Lidocaine and no music
Group 2 - right breast lidocaine \& no calming music
Lidocaine
Applied to breast skin
No Music
No music played during mammography
Left Breast Lidocaine and calming music
Group 3 - left breast lidocaine \& calming music
Lidocaine
Applied to breast skin
Calming Music
Played during mammography
Left Breast Lidocaine and no music
Group 4 - left breast lidocaine \& no calming music
Lidocaine
Applied to breast skin
No Music
No music played during mammography
Interventions
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Lidocaine
Applied to breast skin
Calming Music
Played during mammography
No Music
No music played during mammography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have two breasts
Exclusion Criteria
* Must not have a contraindication for using lidocaine: e.g no history of allergic reactions to lidocaine.
* Must not have had history of breast cancer, breast surgery, radiation to the chest wall.
* Must not have broken or irritated skin (as determined by the study nurses).
* May not be lactating or breast feeding
18 Years
FEMALE
Yes
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Kenneth Kist, MD
Role: PRINCIPAL_INVESTIGATOR
CTRC @ UTHSCSA
Virginia Kaklamani, MD
Role: STUDY_CHAIR
CTRC @ UTHSCSA
Pamela Otto, MD
Role: STUDY_CHAIR
CTRC @ UTHSCSA
Locations
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UT Health Cancer Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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HSC20160392H
Identifier Type: OTHER
Identifier Source: secondary_id
CTMS 16-0045
Identifier Type: -
Identifier Source: org_study_id
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