We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BEATS 2: Music Therapy in Sickle Cell

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233269
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
Kulas Foundation
Information provided by (Responsible Party):
Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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]?


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Music Therapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BEATS 2: The Effects of Music Therapy on Young Adults With Sickle Cell Disease
Actual Study Start Date : June 26, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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).
 Behavioral: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline in scores on the Sickle Cell Self-Efficacy Scale (SCSES) [ Time Frame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8. ]

    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.


  2. Change from baseline in scores on the Wake Forest Trust in the Medical Profession Scale [ Time Frame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8. ]
    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.

  3. Change from baseline in scores on the Seidman Sickle Cell Knowledge Quiz [ Time Frame: Baseline, immediately after session 4, 4 weeks after session 4, immediately after session 8, 4 weeks after session 8. ]
    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).


Secondary Outcome Measures :
  1. Change from baseline in rate of adherence to clinic appointments during the one-year study period. [ Time Frame: Baseline, 12 months ]
    Adherence is the extent to which a person's behavior coincides with medical or prescribed health advice (Julius, 2009).Adherence will be measured regularly throughout the study via medical record review. In order to assess adherence, the following data will be obtained from the medical record on each patient throughout the study period: 1) Total scheduled clinic visits with Adult Sickle Cell Disease Clinic, 2) Number of missed clinic visits to Adult Sickle Cell Disease Clinic due to no show, cancellation, or rescheduling


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233269


Locations
Layout table for location information
United States, Ohio
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Kulas Foundation
Investigators
Layout table for investigator information
Principal Investigator: Samuel N Rodgers-Melnick, MT-BC University Hospitals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Samuel Rodgers-Melnick, Music Therapist-Board Certified, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03233269    
Other Study ID Numbers: 06-17-07
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn