Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45
This study is designed to evaluate two methods of reducing pain and discomfort caused by
mammography, one of the barriers to the procedure.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Measure of discomfort of mammography
The Primary outcome measure will be the response to question 1 of the post-mammogram questionnaire: 'How painful was today's mammogram?' [O-no hurt, 1-hurts a little bit, 2-hurts a little more, 3-hurts even more, 4-hurts a whole lot, 5-hurts worst]. The response to question 2, 'Was the amount of pain you experienced something that might make you reluctant to return for your next mammogram?' [yes, no] will be of secondary interest. The response to question 5 of the pre-mammogram questionnaire: 'How painful do you expect today's mammogram to be?' [O-no hurt, 1-hurts a little bit, 2-hurts a little more, 3-hurts even more, 4-hurts a whole lot, 5-hurts worst] will be used for statistical adjustment and to compute a change score as described in the protocol.
Kenneth Kist, MD
University of Texas
United States: Food and Drug Administration
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