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Women's Mammography Study to Improve Comfort During Mammography

Not Applicable
Completed
Conditions
Pain
Registration Number
NCT02924441
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Brief Summary

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.

Detailed Description

The study is designed to evaluate two methods of reducing pain and anxiety caused by mammography, one of the barriers to the procedure.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
251
Inclusion Criteria
  • Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain.
  • Must have two breasts
Exclusion Criteria
  • May not have taken ibuprofen or other pain medication within the Space last 12 hours (ASA 81 mg dose is allowed).
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Questionnaire to determine the change (or difference) in pain level before and after mammogramThe questionnaires are completed before and after mammography, on the same day (questionnaire will be completed before leaving the mammography clinic the day of mammography).

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).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

UT Health Cancer Center

🇺🇸

San Antonio, Texas, United States

UT Health Cancer Center
🇺🇸San Antonio, Texas, United States

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