Women's Mammography Study to Improve Comfort During Mammography

Pain Clinical Trial

Official title:

A Study Attempting to Improve the Comfort During Screening Mammography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924441
• Other study ID #: CTMS 16-0045
• Secondary ID: HSC20160392H
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: August 3, 2022

Study information

• Verified date: October 2022
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: August 3, 2022
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Lidocaine
Applied to breast skin
• Calming Music
Played during mammography
• No Music
No music played during mammography

Locations

Country	Name	City	State
United States	UT Health Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).