Women's Mammography Study to Improve Comfort During Mammography
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
- Pain
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Right Breast Lidocaine and calming music |
Group 1 - right breast lidocaine & calming music |
|
Experimental Right Breast Lidocaine and no music |
Group 2 - right breast lidocaine & no calming music |
|
Experimental Left Breast Lidocaine and calming music |
Group 3 - left breast lidocaine & calming music |
|
Experimental Left Breast Lidocaine and no music |
Group 4 - left breast lidocaine & no calming music |
|
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.