Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    A study attempting to improve the comfort during screening mammography (CTMS# 16-0045)
Previous Study | Return to List | Next Study

Women's Mammography Study to Improve Comfort During Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02924441
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Other: Lidocaine Other: Calming Music Other: No Music Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Study Attempting to Improve the Comfort During Screening Mammography
Study Start Date : October 2016
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: Right Breast Lidocaine and calming music
Group 1 - right breast lidocaine & calming music
Other: Lidocaine
Applied to breast skin
Other Name: Topicaine

Other: Calming Music
Played during mammography

Experimental: Right Breast Lidocaine and no music
Group 2 - right breast lidocaine & no calming music
Other: Lidocaine
Applied to breast skin
Other Name: Topicaine

Other: No Music
No music played during mammography

Experimental: Left Breast Lidocaine and calming music
Group 3 - left breast lidocaine & calming music
Other: Lidocaine
Applied to breast skin
Other Name: Topicaine

Other: Calming Music
Played during mammography

Experimental: Left Breast Lidocaine and no music
Group 4 - left breast lidocaine & no calming music
Other: Lidocaine
Applied to breast skin
Other Name: Topicaine

Other: No Music
No music played during mammography




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924441


Contacts
Layout table for location contacts
Contact: Epp Goodwin 210-450-2872 ctrcreferrals@uthscsa.edu

Locations
Layout table for location information
United States, Texas
UT Health Cancer Center Recruiting
San Antonio, Texas, United States, 78260
Contact: Epp Goodwin    210-450-1000      
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Layout table for investigator information
Principal Investigator: Kenneth Kist, MD CTRC @ UTHSCSA
Study Chair: Virginia Kaklamani, MD CTRC @ UTHSCSA
Study Chair: Pamela Otto, MD CTRC @ UTHSCSA

Layout table for additonal information
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02924441     History of Changes
Other Study ID Numbers: CTMS 16-0045
HSC20160392H ( Other Identifier: University of Texas Health Science Center- San Antonio )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The University of Texas Health Science Center at San Antonio:
Mammogram
Pain Management
Lidocaine

Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action