Music Therapy for Sickle Cell Disease

(MULTI-MUSIQOLS Trial)

Recruiting at 1 trial location

Overseen By Coretta Jenerette, PhD, RN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Visual, hearing, cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6-8 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot participate if you are currently engaging in mind-body therapies for pain management under a healthcare professional's supervision.

What data supports the effectiveness of the treatment Music Therapy for Sickle Cell Disease?

Research shows that music therapy can help reduce pain and anxiety in people with sickle cell disease, as well as improve their quality of life and coping skills. Studies have also found that music therapy is effective in managing symptoms like pain and anxiety in other serious illnesses. ^{1 2 3 4 5}

Is music therapy safe for humans?

Music therapy is generally considered safe for humans and is used as a low-risk way to help manage pain, anxiety, and discomfort in various medical conditions, including cancer and pediatric care. ^{4 6 7 8 9}

How does music therapy differ from other treatments for sickle cell disease?

Music therapy is unique because it uses music to help manage pain, anxiety, and fatigue in sickle cell disease, focusing on improving quality of life and coping skills rather than directly targeting the disease itself. Unlike traditional medical treatments, it offers a non-invasive, supportive approach that can enhance self-efficacy and knowledge about the condition, especially during transitions in care. ^{2 4 8 10 11}

What is the purpose of this trial?

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.

Research Team

Jeffery A Dusek, PhD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for adolescents and adults aged 14 or older with sickle cell disease. It's designed to see if music therapy can improve their quality of life. Participants will be split into groups, some getting in-person music therapy, others a mix of in-person and virtual sessions, or health education as a comparison.

Inclusion Criteria

I am 14 years old or older.

My electronic health record shows I have sickle cell disease.

Meet AAPT criteria for chronic SCD pain which includes: A diagnosis of SCD confirmed by laboratory testing, Reports of ongoing pain present on most days over the past 6 months, Displaying at least one of the following signs on clinical exam, There is no other diagnosis that better explains the signs and symptoms, Be able to speak and understand English, Have an email address and access to mobile device with a functioning data plan, Reporting that pain interfered with daily activities at least 1-2 days in the past week

Exclusion Criteria

Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018

I have a major issue with my sight, hearing, or thinking.

I have a major medical event planned within the next 14 weeks, not including blood transfusions or pain treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either in-person or hybrid music therapy or health education sessions over 6 to 8 weeks

6-8 weeks

6 visits (1 in-person, 5 virtual for HybMT and HybHE; 6 in-person for InMT)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction surveys and home practice assessment

6 weeks

Treatment Details

Interventions

• Music Therapy

Trial Overview The study tests the feasibility of music therapy versus health education for sickle cell patients through three different setups: all in-person sessions, a hybrid of one in-person followed by virtual sessions, and one in-person plus virtual health education. Success is measured by six specific goals like attendance and data collection.

Participant Groups

Group I: InMT Experimental Treatment 1 Intervention

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).

Group II: HybMT Experimental Treatment 1 Intervention

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).

Group III: HybHE Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Prisma Health-Upstate

Collaborator

Trials

91

Recruited

47,500+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Massachusetts Chan Medical School, Worcester

Collaborator

Trials

3

Recruited

850+

Findings from Research

A national clinical practice review in Australia highlighted the role of music therapy in managing symptoms for children with cancer, indicating its potential benefits in pediatric oncology settings.

Feedback from patients and families at a major pediatric hospital suggests that music therapy services are valuable, prompting recommendations for further research and professional development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy services in pediatric oncology: a national clinical practice review. Tucquet, B., Leung, M.[2018]

A study involving 150 seriously ill patients across various inpatient units demonstrated that music therapy significantly reduced anxiety levels after a single bedside session.

The intervention was found to be feasible and well-received, with patients showing high interest and satisfaction, indicating that music therapy can be effectively integrated into general inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soothing the heart with music: A feasibility study of a bedside music therapy intervention for critically ill patients in an urban hospital setting. Fallek, R., Corey, K., Qamar, A., et al.[2020]

In a study involving 259 pediatric patients in the intensive care unit, live music therapy significantly reduced heart rates, breathing rates, and levels of discomfort during the sessions.

The findings suggest that music therapy could be an effective nonpharmacological intervention to help manage pain and anxiety in critically ill children, despite its limited current use in PICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a live music therapy intervention on critically ill paediatric patients in the intensive care unit: A quasi-experimental pretest-posttest study. Mata Ferro, M., Falcó Pegueroles, A., Fernández Lorenzo, R., et al.[2023]

A meta-analysis of 183 studies across 11 medical specialties found that music therapy interventions have significantly greater positive effects on outcomes like pain, well-being, mood, and nausea/vomiting compared to music medicine interventions.

The analysis particularly highlighted benefits for patients with cancer, those who are terminally ill, and patients with HIV, indicating that music therapy can be an effective complementary treatment in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music and music therapy on medical patients: a meta-analysis of the research and implications for the future. Dileo, C.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Music therapy services in pediatric oncology: a national clinical practice review. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Music Therapy on Quality of Life in Adults with Sickle Cell Disease (MUSIQOLS): A Mixed Methods Feasibility Study. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Effects of a standardized musical intervention on the management of pain and anxiety-state of sickle-cell adolescents]. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Delivery and Effectiveness of Music Therapy in Hematology and Oncology: An EMMPIRE Retrospective Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Soothing the heart with music: A feasibility study of a bedside music therapy intervention for critically ill patients in an urban hospital setting. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Music Therapy as a Form of Nonpharmacologic Pain Modulation in Patients with Cancer: A Systematic Review of the Current Literature. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

The effect of a live music therapy intervention on critically ill paediatric patients in the intensive care unit: A quasi-experimental pretest-posttest study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

An Explorative Study of Qualities in Interactive Processes with Children and Their Parents in Music Therapy during and after Pediatric Hematopoietic Stem Cell Transplantation. [2020]

9. Canada pubmed.ncbi.nlm.nih.gov

Effects of music and music therapy on medical patients: a meta-analysis of the research and implications for the future. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

The effects of music therapy on transition outcomes in adolescents and young adults with sickle cell disease. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The Effects of a Single Electronic Music Improvisation Session on the Pain of Adults with Sickle Cell Disease: A Mixed Methods Pilot Study. [2022]