BEATS 2: Music Therapy in Sickle Cell

NCT03233269 | Completed

• 1 other identifier: 06-17-07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change from baseline in scores on the Sickle Cell Self-Efficacy Scale (SCSES)

  Self-efficacy is the conviction that one can successfully execute the behavior required to produce the outcome. (Bandura, 1997, p. 193). The SCSES is a nine-item Likert scale originally developed for adults with sickle cell disease (Edwards, Telfair, Cecil, \& Lenoci, 2000) and revised in a follow up study by Clay and Telfair (2007) for adolescents using a sample of 131 individuals age 11-19.

  Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.

• Change from baseline in scores on the Wake Forest Trust in the Medical Profession Scale

  Patient trust is the optimistic acceptance of a vulnerable situation in which the patient believes the health-care provider will take care of the patient's interests (Dugan, Trachtenberg, \& Hall, 2005).The Wake Forest Trust in the Medical Profession Scale is a five-item scale in which respondents express their level of agreement with the following statements: 1) Sometimes doctors care more about what is convenient for them than about their patients' medical needs (reverse coded); 2) Doctors are extremely thorough and careful; 3) You completely trust doctors' decisions about which medical treatments are best; 4) A doctor would never mislead you about anything; 5) All in all, you trust your doctor completely. Responses are summed and scores are on a 5-25 scale, with higher values indicating greater trust.

  Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.

• Change from baseline in scores on the Seidman Sickle Cell Knowledge Quiz

  Sickle Cell Disease knowledge will be measured using the Seidman Sickle Cell Knowledge Quiz developed specifically for this study. The Seidman Sickle Cell Knowledge Quiz is adapted from questions from the Sickle Cell Disease Knowledge Test (Kaslow et al., 2000) and How Much Do I Know About Sickle Cell Disease (Baskin, Collins, Kaslow, \& Hsu, 2002).

  Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8.

Secondary Outcomes (1)

• Change from baseline in rate of adherence to clinic appointments during the one-year study period.

  Baseline, 12 months

Study Arms (1)

Music Therapy Group

EXPERIMENTAL

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).

Behavioral: Music Therapy

Interventions

Music Therapy 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.

Music Therapy Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Kulas Foundation: collaborator

Study Sites (1)

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Links

• Website for music therapy program at UH Seidman Cancer Center

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Samuel N Rodgers-Melnick, MT-BC

  University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Music Therapist-Board Certified

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 28, 2017
• Study Start: June 26, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

US (1)