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

BMJ Open. 2026 Mar 9;16(3):e115036. doi: 10.1136/bmjopen-2025-115036.

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.

PMID:41802789 | DOI:10.1136/bmjopen-2025-115036