Pain
Conditions
Keywords
Mammogram, Pain Management, Lidocaine
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.
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.
Interventions
OTHERLidocaine
Applied to breast skin
OTHERCalming Music
Played during mammography
OTHERNo Music
No music played during mammography
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire to determine the change (or difference) in pain level before and after mammogram | 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). |
Countries
United States
Outcome results
None listed