N/A
N=30
Music Therapy in Sickle Cell Transition Study
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT02466555 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES) — -1.73 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Music Therapy (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES) |
-1.73 | — |
| PRIMARY Change (T1-T5) From Baseline in Scores on the Wake Forest Trust in the Medical Profession Scale |
.18 | — |
| PRIMARY Change (T1-T5) From Baseline in Scores on the Seidman Sickle Cell Knowledge Quiz |
-1.88 | — |
| SECONDARY Change From Baseline in Percentage of Attended Clinic Appointments During the One-year Study Period. |
10 | — |
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 sickle cell disease during transition.
Primary Hypotheses:
Compared to baseline, young adult patients with sickle cell disease who receive the music therapy interventions will report:
1. Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES),
2. Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and
3. Higher sickle cell disease knowledge as measured by the Seidman Sickle Cell Knowledge Quiz.
Secondary Hypotheses
1. Compared to the one year prior to the study period, young adults with sickle cell disease who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period.
Additional Questions
1. Do music therapy interventions influence attendance to scheduled blood transfusions?
2. Do music therapy interventions influence the rate of hospital utilization as measured by Emergency Department visits, Acute Care Clinic visits, and admissions during the study period compared to the previous year?
3. 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?
4. 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?
Eligibility Criteria
Inclusion Criteria
- Subject is between 18 and 23 years of age
- Subject is diagnosed with sickle cell disease
- Subject is able to speak and understand English
- Subject is currently scheduled for quarterly appointments in the Bridge Clinic
Exclusion Criteria
- Subject has significant hearing impairment that has not been corrected
- Subject has significant visual impairment that has not been corrected
Data sourced from ClinicalTrials.gov (NCT02466555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.