Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
CompletedPhase 2NCT04906447
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 observing and gathering information on implementation in three health systems: University of Illinois Hospital \& Health Sciences System, University of Florida Health, and Duke University Health Systems. Each serves a large population with SCD, uses EPIC as their electronic health record, and has a Clinical and Translational Science Award (CTSA), which will help speed the translation of discovery into improved patient care. During the UH3 Implementation Phase, the 3-arm, 3-site randomized controlled trial will follow a quantitative modified SMART design, a pragmatic trial that evaluates adaptive interventions where the guided relaxation and acupuncture interventions respond to patients' characteristics and evolving pain status. The investigators rely on the Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The use of complementary and integrative health (CIH) therapies by those with SCD to reduce pain and opioid use, to help enable them to better cope with their pain, is well known, but there are few studies that evaluate the effectiveness of these therapies, and none that also evaluates the implementation across multiple health care systems and patient populations as this study will. Aim 1: Determine the effectiveness of guided relaxation and acupuncture as compared to usual care in decreasing pain and opioid use for SCD patients. Hypothesis: At 6-weeks, SCD patients randomized to either CIH intervention will have a greater decrease in pain, opioid use, sleep, anxiety, depressive symptoms, and pain catastrophizing compared to SCD patients randomized to usual care. Aim 2: Identify the best adaptive intervention for improved outcomes by documenting outcomes among adaptive intervention sequences: (…
Study details
- Official title
- Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
- Conditions
- Interventions
- Behavioral: Guided Relaxation
- Other: Acupuncture
- Sponsor
- University of Illinois at Chicago
- Collaborators
- University of Florida; Duke University; National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2021-11-24
- Primary completion
- 2025-06-02
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04906447