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Validation of the Sickle Cell Disease Pain Burden Interview

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804362
First Posted: December 8, 2008
Last Update Posted: July 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center
  Purpose
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
Sickle Cell Disease Pain

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

Resource links provided by NLM:


Further study details as provided by William Zempsky, MD, Connecticut Children's Medical Center:

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

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)
  Eligibility

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.
Criteria

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
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


Locations
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
ClinicalTrials.gov Identifier: NCT00804362     History of Changes
Other Study ID Numbers: 08-093
First Submitted: December 5, 2008
First Posted: December 8, 2008
Last Update Posted: July 30, 2013
Last Verified: July 2013

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