BEATS 2: Music Therapy in Sickle Cell

NCT ID: NCT03233269

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-26
• Study Completion Date: 2018-09-30

Brief Summary

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 adult patients with SCD.

Primary Hypotheses:

Compared to baseline, young adult patients with SCD who receive the music therapy interventions will report:

Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES), Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and Higher SCD knowledge as measured by the Seidman Sickle Cell Knowledge Quiz.

Secondary Hypotheses Compared to the one year prior to the study period, young adults with SCD who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period.

Additional Questions Do music therapy interventions influence the rate of hospital utilization as measured by ED visits, Acute Care Clinic (ACC) visits, and admissions during the study period compared to the previous year? Do music therapy interventions influence adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the study period? Do music therapy interventions influence adherence to iron chelation therapy for patients receiving iron chelation therapy as measured by ferritin count during the study period? Does the schedule of music therapy interventions in this study improve outcomes more significantly than the schedule of music therapy interventions from [IRB# 03-15-30]?

Conditions

Sickle Cell Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music Therapy Group

Music therapy is the clinical and evidence-based use of music interventions to accomplish individualized goals within a therapeutic relationship by a credentialed professional who has completed an approved music therapy program. Music therapy is an established health profession in which music is used within a therapeutic relationship to address physical, emotional, cognitive, and social needs of individuals (American Music Therapy Association \[AMTA\], 2013, para 1 and 2).

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: BEHAVIORAL

During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment via a prerecorded video. The Music Therapist will then engage the patients in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.

Interventions

Music Therapy

During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment via a prerecorded video. The Music Therapist will then engage the patients in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subject is between 18 and 35 years of age
• Subject is diagnosed with sickle cell disease
• Subject is able to speak and understand English
• Subject has a working email address.
• Subject has access to a mobile device with email capabilities.

Exclusion Criteria

• Subject has significant hearing impairment that has not been corrected
• Subject has significant visual impairment that has not been corrected

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kulas Foundation

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samuel Rodgers-Melnick

Music Therapist-Board Certified

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel N Rodgers-Melnick, MT-BC

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Countries

United States

Related Links

http://www.uhseidman.org/musictherapy

Website for music therapy program at UH Seidman Cancer Center

Other Identifiers

06-17-07

Identifier Type: -

Identifier Source: org_study_id