MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease

Description

This is a multi-site, multi-visit feasibility RCT of music therapy (MT) among adolescent and adult patients (aged 14 and older) with sickle cell disease (SCD). Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE). Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule. The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met. This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.

Conditions

Sickle Cell Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

This is a multi-site, multi-visit feasibility RCT of music therapy (MT) among adolescent and adult patients (aged 14 and older) with sickle cell disease (SCD). Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE). Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule. The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met. This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.

MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)

MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Cleveland

UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center, Cleveland, Ohio, United States, 44106

Greenville

Prisma Health Lifespan Comprehensive SCD Program, Greenville, South Carolina, United States, 29605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Be aged 14 years or older;
  • 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:
  • * 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.
  • 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).

Ages Eligible for Study

14 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

Jeffery A Dusek, PhD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

2027-08-31