Women's Mammography Study to Improve Comfort During Mammography

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Lidocaine; Other: Calming Music; Other: No Music

• 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.

Study Timeline

• Study First Submitted: 2016-09-08
• Study Start: 2016-10-01
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Primary Completion: 2020-01-15
• Study Completion: 2022-08-03
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

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

Arm && Interventions

Group	Intervention	Description
Left Breast Lidocaine and calming music	Calming Music	Group 3 - left breast lidocaine \& calming music
Left Breast Lidocaine and no music	Lidocaine	Group 4 - left breast lidocaine \& no calming music
Right Breast Lidocaine and calming music	Lidocaine	Group 1 - right breast lidocaine \& calming music
Right Breast Lidocaine and no music	Lidocaine	Group 2 - right breast lidocaine \& no calming music
Right Breast Lidocaine and calming music	Calming Music	Group 1 - right breast lidocaine \& calming music
Right Breast Lidocaine and no music	No Music	Group 2 - right breast lidocaine \& no calming music
Left Breast Lidocaine and calming music	Lidocaine	Group 3 - left breast lidocaine \& calming music
Left Breast Lidocaine and no music	No Music	Group 4 - left breast lidocaine \& no calming music

Primary Outcome Measures

Name	Time	Method
Questionnaire to determine the change (or difference) in pain level before and after mammogram	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).	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).

Trial Locations

Locations (1)

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