Music Therapy in Sickle Cell Transition Study

• ClinicalTrials.gov Identifier: NCT02466555
• Recruitment Status: Completed
• First Posted: June 9, 2015
• Results First Posted: September 13, 2019
• Last Update Posted: September 13, 2019
• Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Kulas Foundation
• Information provided by (Responsible Party): Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sickle Cell Disease
• Intervention: Behavioral: Music Therapy
• Enrollment: 30

Participant Flow

Recruitment Details
Pre-assignment Details	Thirty-three participants with SCD were approached for recruitment. Three declined due to scheduling conflicts or disinterest. Thirty (90.9%) participants agreed to participate and completed written consent.

Arm/Group Title	Music Therapy Group
Arm/Group Description	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, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may
Period Title: Overall Study
Started	30
Completed	28
Not Completed	2
Reason Not Completed
Lost to Follow-up	2

Baseline Characteristics

Arm/Group Title		Music Therapy Group
Arm/Group Description		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, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team 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.
Overall Number of Baseline Participants		28
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	<=18 years	0
	Between 18 and 65 years	28
	>=65 years	0
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	28 participants
		21.04 (1.40)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	Female	14 50.0%
	Male	14 50.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	28 100.0%
	White	0 0.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	28 participants
		28
Type of Sickle Cell Disease; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	HbSS	19 67.9%
	HbSC	6 21.4%
	HbSBeta+ Thalassemia	2 7.1%
	HbSBeta0 Thalassemia	1 3.6%
Sickle Cell Disease Treatment; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	Hydroxyurea	7 25.0%
	Chronic transfusions	9 32.1%
	None	12 42.9%

Outcome Measures

1. Primary Outcome

Title	Change (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES)
Description	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. The total score is reported with a minimum score of 9 and a maximum score of 45. Higher scores represent higher/better self-efficacy.
Time Frame	Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group
Arm/Group Description:	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, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team 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.
Overall Number of Participants Analyzed	28
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-1.73; (-5.55 to 2.09)

2. Primary Outcome

Title	Change (T1-T5) From Baseline in Scores on the Wake Forest Trust in the Medical Profession Scale
Description	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.
Time Frame	Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group
Arm/Group Description:	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, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team 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.
Overall Number of Participants Analyzed	28
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	.18; (-2.04 to 2.39)

3. Primary Outcome

Title	Change (T1-T5) From Baseline in Scores on the Seidman Sickle Cell Knowledge Quiz
Description	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). The total score is reported with a minimum score of 0 and a maximum score of 12. Higher scores represent greater knowledge of sickle cell disease.
Time Frame	Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group
Arm/Group Description:	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, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may
Overall Number of Participants Analyzed	28
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-1.88; (-2.80 to -0.97)

4. Secondary Outcome

Title	Change From Baseline in Percentage of Attended Clinic Appointments During the One-year Study Period.
Description	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. Adherence to clinic appointments is calculated as total number of attended clinic visits divided by total number of scheduled clinic visits (including no shows) multiplied by 100. The reported adherence percentage is the difference between percentage of visits attended during the 12 months study period minus the percentage of visits attended during the 12 months before the study period.
Time Frame	Baseline (T1), 12 months (T5)

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group
Arm/Group Description:	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, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: percentage of appointments attended
	10 (40)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Music Therapy Group
Arm/Group Description	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, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may
All-Cause Mortality
	Music Therapy Group
	Affected / at Risk (%)
Total	0/30 (0.00%)
Serious Adverse Events
	Music Therapy Group
	Affected / at Risk (%)
Total	0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Music Therapy Group
	Affected / at Risk (%)
Total	0/30 (0.00%)

Limitations and Caveats

Limitations to this study include missing data from some participants, lack of a control group, convenience sampling and small sample size.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Samuel Rodgers-Melnick, MT-BC, music therapist
• Organization: University Hospitals Connor Integrative Health Network
• Phone: 216-844-7727
• EMail: Samuel.RodgersMelnick@UHhospitals.org

• Responsible Party: Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT02466555
• Other Study ID Numbers: 03-15-30
• First Submitted: June 4, 2015
• First Posted: June 9, 2015
• Results First Submitted: November 1, 2018
• Results First Posted: September 13, 2019
• Last Update Posted: September 13, 2019