Women's Mammography Study To Improve Comfort During Mammography

This study has been terminated.
(Lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01716052
First received: October 18, 2012
Last updated: October 16, 2014
Last verified: October 2014

October 18, 2012
October 16, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
Measure of discomfort of mammography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01716052 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Women's Mammography Study To Improve Comfort During Mammography
Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45

The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.

This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Pain
  • Drug: placebo
    Lactulose
  • Drug: Ibuprofen
  • Active Comparator: Ibuprofen
    Pfizer 200 mg caplets (Advil)
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Placebo
    Lactulose
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01716052
CTRC 11-45, HSC20120142H
No
Kenneth A. Kist,, The University of Texas Health Science Center at San Antonio
Kenneth A. Kist,
Not Provided
Principal Investigator: Kenneth Kist, MD University of Texas
The University of Texas Health Science Center at San Antonio
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP