Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT06853158
Eligibility Criteria:
Inclusion Criteria:
1. Be aged \>=14 years old
2. Have a diagnosis of SCD present in their electronic health record (EHR);
3. Meet Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT) criteria for chronic SCD pain which includes:
3a. A diagnosis of SCD confirmed by laboratory testing (present in EHR per eligibility criteria 2)
3b. Reports of ongoing pain present on most days over the past 6 months either in a single location or in multiple locations (to be obtained at screening)
3c. Displaying at least one of the following signs on clinical exam (to be obtained from providers' clinical notes in the EHR
* Palpation of the region of reported pain elicits focal pain or tenderness;
* Movement of the region of reported pain elicits focal pain;
* Decreased range of motion or weakness in the region of reported pain;
* Evidence of skin ulcer in the region of reported pain;
* Evidence of hepatobiliary or splenic imaging abnormalities (e.g., splenic infarct, chronic pancreatitis) consistent with the region of reported pain; or
* Evidence of imaging abnormalities consistent with bone infarction or avascular necrosis in the region of reported;
3d. There is no other diagnosis that better explains the signs and symptoms (to be obtained from providers following referral and pre-screening)
4\. Be able to speak and understand English;
5\. Have an email address and access to mobile device with a functioning data plan
6\. Reporting that pain interfered with daily activities at least 1-2 days in the past week.
Exclusion Criteria:
1. Have a significant visual, hearing, or cognitive impairment
2. Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018
3. Are currently engaging in mind-body therapies under the supervision of a healthcare professional specifically for pain management
4. Have a planned major medical event in the next 14 weeks such as (but not limited to) childbirth, orthopedic surgery, gene therapy, or stem cell transplant (These criteria do not include blood transfusions, exchange transfusions, or other pharmacologic pain treatment).
Qualitative interviews will be conducted with \~24 participants who received the interventions (with equal numbers across the InMT, HybMT and HybHE groups). Participants will be purposively sampled to include equal distribution across sites in proportion to recruitment.
Stakeholder surveys and qualitative interviews will be conducted among \~20 relevant staff stakeholders (\~10 per site), including healthcare providers \& staff, music therapists and HybHE interventionists.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT06853158
Study Brief:
Protocol Section:
NCT06853158