Women's Mammography Study to Improve Comfort During Mammography
Status
Completed
Conditions
Pain
Treatments
Other: Calming Music
Other: No Music
Other: Lidocaine
Study type
Interventional
Funder types
Other
Identifiers
Details and patient eligibility
About
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.
Full description
The study is designed to evaluate two methods of reducing pain and anxiety caused by mammography, one of the barriers to the procedure.
Enrollment
251 patients
Sex
Female
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
251 participants in 4 patient groups
Right Breast Lidocaine and calming music
Experimental group
Description:
Group 1 - right breast lidocaine \& calming music
Treatment:
Other: Lidocaine
Other: Calming Music
Right Breast Lidocaine and no music
Experimental group
Description:
Group 2 - right breast lidocaine \& no calming music
Treatment:
Other: Lidocaine
Other: No Music
Left Breast Lidocaine and calming music
Experimental group
Description:
Group 3 - left breast lidocaine \& calming music
Treatment:
Other: Lidocaine
Other: Calming Music
Left Breast Lidocaine and no music
Experimental group
Description:
Group 4 - left breast lidocaine \& no calming music
Treatment:
Other: Lidocaine
Other: No Music
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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