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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores music therapy to help manage chronic pain in people with sickle cell disease (SCD). Participants will be divided into three groups: one will attend all sessions in person, another will have a mix of in-person and virtual sessions, and a third will receive health education sessions instead. The trial aims to assess the practicality of conducting this type of study and gather participant feedback about their experiences. It seeks individuals aged 14 or older who have sickle cell disease and experience daily pain affecting their daily activities. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve pain management strategies for SCD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that music therapy is generally safe for people with sickle cell disease. Studies have explored how music therapy can improve quality of life, help manage pain, and enhance coping skills, with no serious side effects reported.

For example, one study examined a 6-session music therapy program and found that participants with sickle cell disease responded positively. It helped them feel more in control and manage their pain better, without any harm. Another study found that music therapy improved patients' ability to cope with their condition, again with no negative effects reported.

Overall, music therapy appears to be a well-tolerated way to support people with sickle cell disease, providing benefits without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about music therapy for sickle cell disease because it offers a non-drug approach that might help manage pain and improve quality of life. Unlike standard treatments that often rely on medications like hydroxyurea or opioids to alleviate symptoms, music therapy provides a creative outlet that could reduce stress and anxiety. The therapy's flexibility is another plus, as participants can attend sessions in-person or virtually, making it accessible and adaptable to individual needs. By exploring how music therapy can complement or even enhance traditional care, researchers hope to uncover new ways to support those living with sickle cell disease.

What evidence suggests that this trial's treatments could be effective for sickle cell disease?

Research has shown that music therapy can help people with sickle cell disease (SCD). Studies have found that it manages sudden pain and boosts confidence in handling health issues. Participants in music therapy have reported better sleep and less pain. These benefits make it a promising option for those with SCD. In this trial, participants will experience different music therapy approaches, including in-person sessions and a hybrid of in-person and virtual sessions. Music therapy has also benefited people with other serious illnesses, suggesting a wide-ranging impact. Overall, these findings support the idea that music therapy can improve the quality of life for people with SCD. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeffery A Dusek, PhD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8760983/

Effects of Music Therapy on Quality of Life in Adults with Sickle ... Music therapy has been shown to be effective in improving sleep quality among cancer patients undergoing treatment and hospitalized adults.

2. news.uhhospitals.org news.uhhospitals.org/news-releases/articles/2022/02/music-therapy-improves-ability-to-cope-with-pain-for-patients-with-sickle-cell-disease

Music Therapy Improves Ability to Cope with Pain for Patients ... These studies support the benefits of music therapy for managing acute pain, improving self-efficacy, and improving sickle cell disease ...

3. academic.oup.com academic.oup.com/jscd/article/1/Supplement_1/yoae002.012/7686672

Feasibility of Music Therapy in Sickle Cell Disease In preliminary analyses, MT participants demonstrated significant mean improvements in self-efficacy (5.42), sleep disturbance (-1.49), pain ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9751180/

Clinical Delivery and Effectiveness of Music Therapy in ... Music therapy (MT) has been shown to improve outcomes for patients with sickle cell disease (SCD) and patients with hematologic and/or oncologic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02466555

Music Therapy in Sickle Cell Transition Study The purpose of this study is to investigate the effects of the BEATS Music Therapy Program on the self-efficacy, trust, knowledge, and adherence of young ...

6. dovepress.com dovepress.com/article/download/72221

Effects of Music Therapy on Quality of Life in Adults with ... Here, we report the results of a study designed to determine the feasibility, acceptability, and preliminary efficacy of a 6-session music therapy intervention.