Status:
COMPLETED
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
Lead Sponsor:
Children's National Research Institute
Conditions:
Sickle Cell Disease
Pain
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
Pain is the primary complication of sickle cell disease (SCD), including vaso-occlusive crises and more persistent, chronic pain. SCD-related pain is associated with significant functional impairment,...
Eligibility Criteria
Inclusion
- Children and adolescents with SCD (HbSS, HbSC, HbS-beta0 thalassemia, or HbS-beta+ thalassemia) between the ages of 8 and 17 years old with pain-related disability and who are currently prescribed short- or long-acting opioid medications.
- Participants will meet at least one of the following criteria for pain-related disability: 1) Have had at least 3 pain crises in the last year, 2) Have had at least one admission for pain in the last year, or 3) Have missed at least one week of school (5 days) in the last year
- Current prescription of opioids will be confirmed by participants' primary hematologist, review of the electronic medical record, and discussion with the family.
Exclusion
- Patients and caregivers with limited English proficiency, a neurodevelopmental delay, or a visual or motor impairment that would interfere with their ability to complete the assessments and intervention.
- Documented history of major depressive disorder in medical record and/or through discussion with their primary hematology suggesting that patients may need a specific and higher level of therapeutic care.
- Patients have regularly scheduled outpatient therapy sessions outside of the study.
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04388241
Start Date
September 23 2020
End Date
August 4 2022
Last Update
September 6 2022
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010