Women's Mammography Study to Improve Comfort During Mammography

The University of Texas Health Science Center at San Antonio251 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

251

Conditions

Pain

Interventions

LidocaineOTHER

Applied to breast skin

Calming MusicOTHER

Played during mammography

No MusicOTHER

No music played during mammography

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UT Health Cancer Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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).

Data from ClinicalTrials.gov

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