Women's Mammography Study to Improve Comfort During Mammography

NCT ID: NCT02924441

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2022-08-03

Brief Summary

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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

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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Right Breast Lidocaine and calming music

Group 1 - right breast lidocaine \& calming music

Group Type EXPERIMENTAL

Lidocaine

Intervention Type OTHER

Applied to breast skin

Calming Music

Intervention Type OTHER

Played during mammography

Right Breast Lidocaine and no music

Group 2 - right breast lidocaine \& no calming music

Group Type EXPERIMENTAL

Lidocaine

Intervention Type OTHER

Applied to breast skin

No Music

Intervention Type OTHER

No music played during mammography

Left Breast Lidocaine and calming music

Group 3 - left breast lidocaine \& calming music

Group Type EXPERIMENTAL

Lidocaine

Intervention Type OTHER

Applied to breast skin

Calming Music

Intervention Type OTHER

Played during mammography

Left Breast Lidocaine and no music

Group 4 - left breast lidocaine \& no calming music

Group Type EXPERIMENTAL

Lidocaine

Intervention Type OTHER

Applied to breast skin

No Music

Intervention Type OTHER

No music played during mammography

Interventions

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Lidocaine

Applied to breast skin

Intervention Type OTHER

Calming Music

Played during mammography

Intervention Type OTHER

No Music

No music played during mammography

Intervention Type OTHER

Other Intervention Names

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Topicaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Kist, MD

Role: PRINCIPAL_INVESTIGATOR

CTRC @ UTHSCSA

Virginia Kaklamani, MD

Role: STUDY_CHAIR

CTRC @ UTHSCSA

Pamela Otto, MD

Role: STUDY_CHAIR

CTRC @ UTHSCSA

Locations

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UT Health Cancer Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20160392H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS 16-0045

Identifier Type: -

Identifier Source: org_study_id

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