Premedication to Reduce Discomfort With Screening Mammography
Primary Purpose
Breast Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
1000 mg acetaminophen
800 mg ibuprofen
1 oz 4% lidocaine gel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Pain focused on measuring Mammogram, Pain, Discomfort, Breast, Pre-medication
Eligibility Criteria
Inclusion Criteria:
- Women scheduled for age-appropriate screening mammography at St. Luke's Breast Cancer Detection Center
- Expect discomfort of 40 or greater on a scale of 0-100
- Willing to arrive 1 hour early for appointment to enroll in study
Exclusion Criteria:
Women who:
- expect discomfort from their mammogram to be < 40 on a scale of 0-100
- cannot understand or read English or who are unable to complete the consent process or questionnaire for reasons such as hearing impairment or other physical or mental disabilities
- have a sensitivity or allergy to acetaminophen, ibuprofen, or lidocaine
- have significant liver or kidney dysfunction
- are breast-feeding
- cannot arrive a minimum of 60 minutes earlier than their appointment time
- have taken any pain relief medications within 24 hours of their mammogram appointment, including over-the-counter medications.
Sites / Locations
- St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center
Outcomes
Primary Outcome Measures
Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram
Satisfaction scores on a visual analog scale after mammogram
Secondary Outcome Measures
Pre-mammogram anxiety scores on a visual anxiety scale at enrollment
Pre-mammogram breast tenderness scores on a visual analog scale at enrollment
Full Information
NCT ID
NCT00382083
First Posted
September 26, 2006
Last Updated
September 27, 2006
Sponsor
Mountain States Tumor and Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00382083
Brief Title
Premedication to Reduce Discomfort With Screening Mammography
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mountain States Tumor and Medical Research Institute
4. Oversight
5. Study Description
Brief Summary
This study will explore the effect of pre-medication with acetaminophen, ibuprofen, and topical lidocaine gel (Topicaine) on the perception of discomfort and overall satisfaction with the mammography experience.
The research questions are:
What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine prior to screening mammography and the perception of discomfort during the procedure?
What is the relationship between perception of discomfort and overall satisfaction with the mammography experience?
What is the relationship between the perception of discomfort and plans for future mammograms?
What other factors are associated with the perception of discomfort and satisfaction?
Detailed Description
Breast cancer is prevalent, deadly, costly, and has low cure rates unless detected in its early stages. Mammography is the key component to early detection, yet it remains underutilized due to cost, access, and factors such as fear of pain.
Multiple studies have shown that most women find mammography uncomfortable, even painful. Yet, little research has been done to find methods to reduce mammography-related discomfort. In an unpublished Master's thesis, this investigator found that women who expected discomfort > 40 on a visual analog scale (VAS) who were pre-medicated with 1000 mg of acetaminophen reported lower discomfort scores than those pre-medicated with placebo, but the sample size was too small to reach statistical significance. Further study on the effects of pre-medication is needed.
Pain should not be associated with a potentially lifesaving procedure. A more comfortable and positive experience with mammography may increase the number of women who participate in regular mammography screening, and, thereby, increase early detection and reduce the mortality rate, costs, and emotional trauma associated with breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Pain
Keywords
Mammogram, Pain, Discomfort, Breast, Pre-medication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
1000 mg acetaminophen
Intervention Type
Drug
Intervention Name(s)
800 mg ibuprofen
Intervention Type
Drug
Intervention Name(s)
1 oz 4% lidocaine gel
Primary Outcome Measure Information:
Title
Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram
Title
Satisfaction scores on a visual analog scale after mammogram
Secondary Outcome Measure Information:
Title
Pre-mammogram anxiety scores on a visual anxiety scale at enrollment
Title
Pre-mammogram breast tenderness scores on a visual analog scale at enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women scheduled for age-appropriate screening mammography at St. Luke's Breast Cancer Detection Center
Expect discomfort of 40 or greater on a scale of 0-100
Willing to arrive 1 hour early for appointment to enroll in study
Exclusion Criteria:
Women who:
expect discomfort from their mammogram to be < 40 on a scale of 0-100
cannot understand or read English or who are unable to complete the consent process or questionnaire for reasons such as hearing impairment or other physical or mental disabilities
have a sensitivity or allergy to acetaminophen, ibuprofen, or lidocaine
have significant liver or kidney dysfunction
are breast-feeding
cannot arrive a minimum of 60 minutes earlier than their appointment time
have taken any pain relief medications within 24 hours of their mammogram appointment, including over-the-counter medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen K. Lambertz, MSN, FNP
Organizational Affiliation
Mountain States Oncology Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul G Montgomery, MD
Organizational Affiliation
St. Luke's Mountain States Tumor Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Theodore A Walters, MD
Organizational Affiliation
Mountain States Tumor Medical Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
12. IPD Sharing Statement
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Premedication to Reduce Discomfort With Screening Mammography
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