Women's Mammography Study to Improve Comfort During Mammography

Study Overview
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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.

Official Title
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A Study Attempting to Improve the Comfort During Screening Mammography

Conditions
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Pain

Intervention / Treatment
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* Other: Lidocaine
* Other: Calming Music
* Other: No Music


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right Breast Lidocaine and calming music<br>Group 1 - right breast lidocaine & calming music | Other: Lidocaine<br>* Applied to breast skin<br>* Other names: Topicaine;Other: Calming Music<br>* Played during mammography<br>|
| Experimental: Right Breast Lidocaine and no music<br>Group 2 - right breast lidocaine & no calming music | Other: Lidocaine<br>* Applied to breast skin<br>* Other names: Topicaine;Other: No Music<br>* No music played during mammography<br>|
| Experimental: Left Breast Lidocaine and calming music<br>Group 3 - left breast lidocaine & calming music | Other: Lidocaine<br>* Applied to breast skin<br>* Other names: Topicaine;Other: Calming Music<br>* Played during mammography<br>|
| Experimental: Left Breast Lidocaine and no music<br>Group 4 - left breast lidocaine & no calming music | Other: Lidocaine<br>* Applied to breast skin<br>* Other names: Topicaine;Other: No Music<br>* No music played during mammography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire to determine the change (or difference) in pain level before and after mammogram | 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). | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammogram, Pain Management, Lidocaine