Validation of the Sickle Cell Disease Pain Burden Interview

This study has been completed.
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center Identifier:
First received: December 5, 2008
Last updated: July 29, 2013
Last verified: July 2013
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.

Sickle Cell Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Correlation with validated measures of pain interference, function, quality of life, and mood. [ Time Frame: Quarterly ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: December 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00804362

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

Responsible Party: William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center Identifier: NCT00804362     History of Changes
Other Study ID Numbers: 08-093 
Study First Received: December 5, 2008
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies processed this record on May 30, 2016