{
  "abstract": "Introduction Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data.Methods and analysis This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice.Ethics and dissemination This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders.Trial registration number NCT06853158.",
  "authors": [
    {
      "affiliations": [
        "Connor Whole Health, University Hospitals of Cleveland, Cleveland, Ohio, USA",
        "Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA",
        "Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA"
      ],
      "name": "Samuel N Rodgers-Melnick"
    },
    {
      "affiliations": [
        "Connor Whole Health, University Hospitals of Cleveland, Cleveland, Ohio, USA",
        "Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA"
      ],
      "name": "Viraj Gorthi"
    },
    {
      "affiliations": [
        "Connor Whole Health, University Hospitals of Cleveland, Cleveland, Ohio, USA",
        "Department of Music, University of Rhode Island, Kingston, Rhode Island, USA"
      ],
      "name": "Angelique Foss"
    },
    {
      "affiliations": [
        "Susan Samueli Integrative Health Institute, University of California - Irvine, Irvine, California, USA"
      ],
      "name": "Ashwini Erande"
    },
    {
      "affiliations": [
        "Clinical Research Center, University Hospitals of Cleveland, Cleveland, Ohio, USA"
      ],
      "name": "Kathryn DiFrancesco"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA",
        "Department of Pediatrics, University Hospitals Rainbow Babies & Children’s Hospital, Cleveland, Ohio, USA"
      ],
      "name": "Amma Owusu-Ansah"
    },
    {
      "affiliations": [
        "Department of Medicine, University Hospitals of Cleveland, Cleveland, Ohio, USA"
      ],
      "name": "Samuel Anim"
    },
    {
      "affiliations": [
        "Connor Whole Health, University Hospitals of Cleveland, Cleveland, Ohio, USA"
      ],
      "name": "Slate Bretz"
    },
    {
      "affiliations": [
        "Department of Pediatric Hematology-Oncology, University of South Carolina, Greenville, South Carolina, USA"
      ],
      "name": "Priscilla Ketter"
    },
    {
      "affiliations": [
        "Department of Pediatric Hematology-Oncology, University of South Carolina, Greenville, South Carolina, USA"
      ],
      "name": "Tranaka Fuqua"
    },
    {
      "affiliations": [
        "Department of Pediatric Hematology-Oncology, University of South Carolina, Greenville, South Carolina, USA"
      ],
      "name": "Alan R Anderson"
    },
    {
      "affiliations": [
        "Department of Family Medicine and Community Health, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA"
      ],
      "name": "Alison Karasz"
    },
    {
      "affiliations": [
        "Sickle Cell Community Consortium, Atlanta, Georgia, USA"
      ],
      "name": "Lakiea Bailey"
    },
    {
      "affiliations": [
        "Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida, USA"
      ],
      "name": "Miriam Ezenwa"
    },
    {
      "affiliations": [
        "School of Nursing, University of California San Francisco, San Francisco, California, USA"
      ],
      "name": "Coretta Jenerette"
    },
    {
      "affiliations": [
        "Susan Samueli Integrative Health Institute, University of California - Irvine, Irvine, California, USA",
        "Department of Medicine, University of California - Irvine, Irvine, California, USA"
      ],
      "name": "Jeffery A Dusek"
    }
  ],
  "title": "MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS): protocol for a mixed-methods randomised controlled trial at two US medical centres",
  "uid": "2e5296c0-421c-541b-9305-f6ab1abe64c4"
}