Status:
ACTIVE_NOT_RECRUITING
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
University of Florida
Duke University
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with Sickle Cell Disease (SCD), while o...
Eligibility Criteria
Inclusion
- Diagnosis of sickle cell disease based on hemoglobin electrophoresis
- Provision of signed and dated informed consent form
- Able to speak and understand English
- Chronic pain, defined as a response of "Some days," "Most days" or "Every day" to the question, "In the past 3 months, how often have you had pain?" (Answer options: Never, Some days, Most days, Every day)
- Current pain interference using the general activity question from PEG, score ≥3 on 0-10 scale
Exclusion
- Has had a stem cell transplant for sickle cell disease
- Current incarceration
- Any other condition that the investigator considers precludes participation in the clinical trial
Key Trial Info
Start Date :
November 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT04906447
Start Date
November 24 2021
End Date
August 31 2025
Last Update
March 17 2025
Active Locations (5)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
Emory University
Atlanta, Georgia, United States, 30322
3
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
4
Johns Hopkins University
Baltimore, Maryland, United States, 21218