An interventional study of Lidocaine and Calming Music in Pain, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Supportive care
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.
The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1 - right breast lidocaine \& calming music
Other: Lidocaine · Other: Calming Music
Group 2 - right breast lidocaine \& no calming music
Other: Lidocaine · Other: No Music
Group 3 - left breast lidocaine \& calming music
Other: Lidocaine · Other: Calming Music
Group 4 - left breast lidocaine \& no calming music
Other: Lidocaine · Other: No Music
Applied to breast skin
Also known as: Topicaine
Played during mammography
No music played during mammography
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).
Time frame: 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).
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio