Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Right Breast Lidocaine and calming music
Group 1 - right breast lidocaine & calming music
  • Other: Lidocaine
    Applied to breast skin
    Other names:
    • 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 names:
    • 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 names:
    • 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 names:
    • Topicaine
  • Other: No Music
    No music played during mammography

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.