Status:
RECRUITING
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Our long-term goal is to reduce stress and improve sickle cell disease (SCD) pain control with less opioid use through an intervention with self-management relaxation/distraction exercises (RDE), name...
Detailed Description
Design. The study is a RCT of the short-term (8 weeks) and long-term (6 months) effects of YCWS on efficacy outcomes (pain, stress, and opioid use). We will stratify patients on worst pain intensity (...
Eligibility Criteria
Inclusion
- with diagnosis of SCD (e.g., HbSS, HbSC, HbS-beta-0 thalassemia, and HbS-beta+ thalassemia); (b) reports moderate to severe level of pain (\>3 on 0-10 scale) related to SCD within previous 24 hours; (c) uses opioid analgesics on "as needed" or "continuous" basis (d) who speaks and reads English; and (e) is 18 years of age or older
Exclusion
- are legally blind; (b) physically unable to complete procedures; (c) previously participated in our relaxation/distraction intervention feasibility study
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT04484272
Start Date
April 29 2021
End Date
June 30 2026
Last Update
August 1 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610