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Validation of the Sickle Cell Disease Pain Burden Interview

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ClinicalTrials.gov Identifier: NCT00804362
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center

Brief Summary:
The purpose of this study is to validate a brief survey tool, the SCD Pain Burden Interview (SCPBI), which can be used in the clinical and/or research settings to assess the impact of pain on children with sickle cell disease.

Condition or disease
Sickle Cell Disease Pain

Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Correlation with validated measures of pain interference, function, quality of life, and mood. [ Time Frame: Quarterly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents diagnosed with sickle cell disease.

Inclusion Criteria:

  • Documented sickle cell disease
  • 7 years old or greater
  • Primary caregiver present at the first visit for children < 18 years of age

Exclusion Criteria:

  • Primary language spoken other than English
  • Patient is in acute pain episode at time of initial visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804362

United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center

Responsible Party: William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00804362     History of Changes
Other Study ID Numbers: 08-093
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn