Skip to main content
OpenTrials
Completed

NCT Number: NCT02924441

Women's Mammography Study to Improve Comfort During Mammography

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UT Health Cancer Center

San Antonio, Texas, 78260, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Other

Applied to breast skin

Other names: Topicaine

Calming Music

Other

Played during mammography

no music

Other

No music played during mammography

Primary outcomes

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

    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).

    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).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

A Study Attempting to Improve the Comfort During Screening Mammography

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Oct 5, 2016
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.