Sickle Cell DiseaseMULTI-MUSIQOLSNCT06853158
MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease
A study testing Music therapy and Health education in people with Sickle Cell Disease, run by University of California, Irvine at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Music therapy and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be aged >=14 years old
- Have a diagnosis of SCD present in their electronic health record (EHR);
- 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
Show all 16Show fewer
- 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.
Who cannot join
- Have a significant visual, hearing, or cognitive impairment
- Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018
- Are currently engaging in mind-body therapies under the supervision of a healthcare professional specifically for pain management
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center
Cleveland, Ohio, 44106
Amma Owusu-Ansah, MD
- Not yet recruiting
Prisma Health Lifespan Comprehensive SCD Program
Greenville, South Carolina, 29605
Alan Anderson, MD
About this study
Official title: MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)
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).
Read more
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.
Read the detailed description
The objectives of this study are to (1) conduct a feasibility randomized control trial (RCT), to examine the data collection processes, and intervention (in-person music therapy [InMT], hybrid MT [HybMT], and hybrid health education [HybHE]) implementation overall and across 2 sites (University Hospitals/Case Western Reserve University [site 1] and Prisma Health/University of South Carolina [site 2]); and (2) evaluate the implementation of the InMT, HybMT, and HybHE interventions using both quantitative data (study records, stakeholder surveys) and qualitative data (interviews).
Three wellbeing programs for individuals with SCD will be compared: (1) InMT, (2) HybMT, and (3) HybHE. Each intervention includes 6 sessions. The treatment period for each group will be 6 to 8 weeks. Each weekly session will last up to one hour in all arms of the study. MT sessions in the InMT and HybMT arms will include the topics of SCD education and MT rationale, breathing exercises, relaxation, imagery, music making, and review and creation of a coping plan for future challenges. The HybHE group will use an adapted version of Project Patients Empowered and Educated Providers (PEEP). Covered topics include: science of SCD, identifying barriers in the Emergency Department, tools for navigating the healthcare system, healthcare based communication, and review and planning for future challenges.
Semi-structured qualitative interview topics will focus on participants' perceptions of the interventions, perceived benefits and burdens of the interventions, and other barriers and facilitators to in-person and hybrid delivery.
- Conditions
- Sickle Cell Disease
- Being tested
- Music therapy, Health education
- Keywords
- feasibility, music therapy, QoL, Sickle cell
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Participants in the 2 experimental MT conditions (In person MT (InMT) or hybrid (inperson.virtual (HybMT) will receive 6 MT sessions over 6 weeks. Each MT session will last no longer than one hour. This 6-week treatment period may be extended to up to 8 weeks if a scheduling conflict prevents a participant from receiving the 6 MT sessions over 6 consecutive weeks.
Health educationOther
The content for the HybHE control was adapted from Project PEEP: Patients Empowered and Educated Providers. The Sickle Cell Community Consortium developed Project PEEP with a grant from Global Blood Therapeutics. Project PEEP addresses unmet needs directly identified and prioritized by a collective of patients with SCD, caregivers, and community-based organizations. The objective is to provide the tools and resources to improve communication and increase positive patient-provider interactions to receive quality, timely care. For the proposed study, we will use modules from the curriculum developed for patients living with SCD.
| Study group | Role | What they receive |
|---|---|---|
| InMT | Experimental | Participants in the InMT will receive 6 in-person MT sessions at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center). Receives: Behavioral: Music therapy |
| HybMT | Experimental | Individuals randomized to Hybrid MT will receive 1 in-person MT session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual MT sessions over secure telehealth platform (e.g. Zoom Health Professional). Receives: Behavioral: Music therapy |
| HybHE | Active comparator | Participants in the HybHE condition will receive 1 in-person health education session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual sessions over secure telehealth platform (e.g. Zoom Health Professional). Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi Musiqols Overall Feasibility (achieving 4/6 of the secondary outcomes).
There are 6 feasibility metrics: (1) Data quality (90%), (2) Screening rate (35%), (3) Recruitment rate (90%), (4) Retention rate (70%), (5) Individual attendance (70%) and (6) Home practice (70%). A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics are met.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Data quality and completeness (90% goal)
This variable is described as being the number of data elements that are correctly completed in the Multi Musiqols REDCap project. The feasibility goal is 90%
Measured: through study completion, an average of 1 year
Successful Screening Rate of Enrolled Individuals (35% goal)
The screening rate as those who were enrolled (i.e., provide written informed consent) divided by those approached for the study who met eligibility criteria. The feasibility goal is 35%.
Measured: At enrollment
Successful Recruitment of Participants into the Study (90% goal)
This translates into randomizing 90% participants who provided written informed consent
Measured: At Enrollment
Successful Retention of Participants (70% goal)
This metric is defined as the number of participants retained until the final survey time point (6-week follow-up) divided by the number of randomized participants.
Measured: through study completion, an average of 1 year
Successful Individual Attendance of Study Sessions (70% goal)
We will consider individual attendance to be acceptable if a given participant attends 4 of 6 sessions in 8 weeks. These 4 sessions must include the first session and any 3 out of the 4 sessions between sessions 2-5. Individual session attendance will be deemed complete if the participant attends 2/3 of the session including (1) the introduction (discussing experience with the MT or HybHE exercise over previous week, providing education on rationale for intervention); (2) setting of the agenda; and (3) the main intervention (e.g., co-creating the music for the intervention, customizing the place and imagery to participants' preferences, experiencing and recording the intervention).
Measured: through study completion, an average of 1 year
Successful Individual Home Practice (70%)
If a given participant practices intervention exercises at least once per week, this will be coded as engaging in the minimum dose of home practice.
Measured: At 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start2 Apr 2025
- Primary completion14 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Type/design of trial This is a multi-site, multi-visit feasibility RCT of three wellbeing interventions among patients aged 14 and older with SCD. Specific unit(s) of assignment and unit(s) of observation The unit of assignment is at the patient level. Specifically, patients with SCD enrolled from SCD centers will be randomly assigned to either InMT, HybMT or HybHE. The unit of observation is the patient.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of California, San Francisco, Case Western Reserve University, Prisma Health-Upstate, University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Jeffrey Dusek, University of California, Irvine
- Investigators
- Jeffery A Dusek, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853158
- Sponsor's protocol ID
- 5448
- Other IDs
- 7R01AT012508-02
- Acronym
- MULTI-MUSIQOLS
- Status last verified
- Jan 2026
- First submitted
- 19 Feb 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodgers-Melnick SN, Gorthi V, Foss A, Erande A, DiFrancesco K, Owusu-Ansah A, Anim S, Bretz S, Ketter P, Fuqua T, Anderson AR, Karasz A, Bailey L, Ezenwa M, Jenerette C, Dusek JA. 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.
PubMed 41802789
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)
- ClinicalTrials.gov ID
- NCT06853158
- Acronym / sponsor ID
- MULTI-MUSIQOLS / 5448
- Conditions
- Sickle Cell Disease
- Keywords
- feasibility, music therapy, QoL, Sickle cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of California, San Francisco, Case Western Reserve University, Prisma Health-Upstate, University of Massachusetts, Worcester
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objectives of this study are to (1) conduct a feasibility randomized control trial (RCT), to examine the data collection processes, and intervention (in-person music therapy [InMT], hybrid MT [HybMT], and hybrid health education [HybHE]) implementation overall and across 2 sites (University Hospitals/Case Western Reserve University [site 1] and Prisma Health/University of South Carolina [site 2]); and (2) evaluate the implementation of the InMT, HybMT, and HybHE interventions using both quantitative data (study records, stakeholder surveys) and qualitative data (interviews).
Three wellbeing programs for individuals with SCD will be compared: (1) InMT, (2) HybMT, and (3) HybHE. Each intervention includes 6 sessions. The treatment period for each group will be 6 to 8 weeks. Each weekly session will last up to one hour in all arms of the study. MT sessions in the InMT and HybMT arms will include the topics of SCD education and MT rationale, breathing exercises, relaxation, imagery, music making, and review and creation of a coping plan for future challenges. The HybHE group will use an adapted version of Project Patients Empowered and Educated Providers (PEEP). Covered topics include: science of SCD, identifying barriers in the Emergency Department, tools for navigating the healthcare system, healthcare based communication, and review and planning for future challenges.
Semi-structured qualitative interview topics will focus on participants' perceptions of the interventions, perceived benefits and burdens of the interventions, and other barriers and facilitators to in-person and hybrid delivery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Type/design of trial This is a multi-site, multi-visit feasibility RCT of three wellbeing interventions among patients aged 14 and older with SCD. Specific unit(s) of assignment and unit(s) of observation The unit of assignment is at the patient level. Specifically, patients with SCD enrolled from SCD centers will be randomly assigned to either InMT, HybMT or HybHE. The unit of observation is the patient.
| Arm | Type | Receives |
|---|---|---|
| InMT | Experimental | Behavioral: Music therapyParticipants in the InMT will receive 6 in-person MT sessions at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center). |
| HybMT | Experimental | Behavioral: Music therapyIndividuals randomized to Hybrid MT will receive 1 in-person MT session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual MT sessions over secure telehealth platform (e.g. Zoom Health Professional). |
| HybHE | Active comparator | Other: Health educationParticipants in the HybHE condition will receive 1 in-person health education session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual sessions over secure telehealth platform (e.g. Zoom Health Professional). |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Be aged >=14 years old
- Have a diagnosis of SCD present in their electronic health record (EHR);
- 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)
Key exclusion criteria (6 listed)
- Have a significant visual, hearing, or cognitive impairment
- Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018
- Are currently engaging in mind-body therapies under the supervision of a healthcare professional specifically for pain management
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyParticipants in the 2 experimental MT conditions (In person MT (InMT) or hybrid (inperson.virtual (HybMT) will receive 6 MT sessions over 6 weeks. Each MT session will last no longer than one hour. This 6-week treatment period may be extended to up to 8 weeks if a scheduling conflict prevents a participant from receiving the 6 MT sessions over 6 consecutive weeks. | Behavioural | HybMT, InMT |
| Health educationThe content for the HybHE control was adapted from Project PEEP: Patients Empowered and Educated Providers. The Sickle Cell Community Consortium developed Project PEEP with a grant from Global Blood Therapeutics. Project PEEP addresses unmet needs directly identified and prioritized by a collective of patients with SCD, caregivers, and community-based organizations. The objective is to provide the tools and resources to improve communication and increase positive patient-provider interactions to receive quality, timely care. For the proposed study, we will use modules from the curriculum developed for patients living with SCD. | Other | HybHE |
Primary outcome
Multi Musiqols Overall Feasibility (achieving 4/6 of the secondary outcomes).
Time frame: through study completion, an average of 1 year
There are 6 feasibility metrics: (1) Data quality (90%), (2) Screening rate (35%), (3) Recruitment rate (90%), (4) Retention rate (70%), (5) Individual attendance (70%) and (6) Home practice (70%). A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics are met.
6 secondary outcomes
Data quality and completeness (90% goal)
Time frame: through study completion, an average of 1 year
Successful Screening Rate of Enrolled Individuals (35% goal)
Time frame: At enrollment
Successful Recruitment of Participants into the Study (90% goal)
Time frame: At Enrollment
Successful Retention of Participants (70% goal)
Time frame: through study completion, an average of 1 year
Successful Individual Attendance of Study Sessions (70% goal)
Time frame: through study completion, an average of 1 year
Successful Individual Home Practice (70%)
Time frame: At 6 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 41802789Rodgers-Melnick SN, Gorthi V, Foss A, Erande A, DiFrancesco K, Owusu-Ansah A, Anim S, Bretz S, Ketter P, Fuqua T, Anderson AR, Karasz A, Bailey L, Ezenwa M, Jenerette C, Dusek JA. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffery A Dusek, PhD principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy and Health education in people with Sickle Cell Disease, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffery A Dusek, PhD (949-824-8841, jdusek@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi Musiqols Overall Feasibility (achieving 4/6 of the secondary outcomes). (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06853158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.