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Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45


N/A
18 Years
N/A
Open (Enrolling)
Female
Pain

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Trial Information

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.


Inclusion Criteria:



- Must have signed the informed consent.

- Must either be getting her first mammogram or based on prior experience be expecting
level 4 or 5 pain

Exclusion Criteria:

- May not have taken ibuprofen or other pain medication within the last 12 hours.

- Must not have a contraindication for taking ibuprofen e.g:

- No history of allergic reactions to ibuprofen or aspirin

- No recent history with the last year of bleeding from GI tract

- Not pregnant or suspected of being pregnant

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Measure of discomfort of mammography

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Kenneth Kist, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas

Authority:

United States: Food and Drug Administration

Study ID:

CTRC 11-45

NCT ID:

NCT01716052

Start Date:

July 2012

Completion Date:

October 2014

Related Keywords:

  • Pain
  • Mammogram
  • Ibuprofen
  • Pain management

Name

Location

Cancer Therapy and Research Center at UTHSCSASan Antonio, Texas  78229