Trial Outcomes & Findings for Music Therapy in Sickle Cell Transition Study (NCT NCT02466555)

Last Updated: 2019-09-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2019-09-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Music Therapy Group 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 Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Music Therapy Group 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 Study Lost to Follow-up	2

Baseline Characteristics

Music Therapy in Sickle Cell Transition Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Music Therapy Group n=28 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	21.04 years STANDARD_DEVIATION 1.40 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants
Type of Sickle Cell Disease HbSS	19 Participants n=5 Participants
Type of Sickle Cell Disease HbSC	6 Participants n=5 Participants
Type of Sickle Cell Disease HbSBeta+ Thalassemia	2 Participants n=5 Participants
Type of Sickle Cell Disease HbSBeta0 Thalassemia	1 Participants n=5 Participants
Sickle Cell Disease Treatment Hydroxyurea	7 Participants n=5 Participants
Sickle Cell Disease Treatment Chronic transfusions	9 Participants n=5 Participants
Sickle Cell Disease Treatment None	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: All participants who participated in the music therapy intervention.

Outcome measures

Outcome measures
Measure	Music Therapy Group n=28 Participants 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.
Change (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES)	-1.73 score on a scale Interval -5.55 to 2.09

PRIMARY outcome

Timeframe: 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

Population: All participants who participated in the music therapy intervention.

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.

Outcome measures

Outcome measures
Measure	Music Therapy Group n=28 Participants 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.
Change (T1-T5) From Baseline in Scores on the Wake Forest Trust in the Medical Profession Scale	.18 score on a scale Interval -2.04 to 2.39

PRIMARY outcome

Timeframe: 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

Population: All participants who participated in the music therapy intervention.

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.

Outcome measures

Outcome measures
Measure	Music Therapy Group n=28 Participants 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.
Change (T1-T5) From Baseline in Scores on the Seidman Sickle Cell Knowledge Quiz	-1.88 score on a scale Interval -2.8 to -0.97

SECONDARY outcome

Timeframe: Baseline (T1), 12 months (T5)

Population: All participants who participated in the music therapy intervention.

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.

Outcome measures

Outcome measures
Measure	Music Therapy Group n=28 Participants 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.
Change From Baseline in Percentage of Attended Clinic Appointments During the One-year Study Period.	10 percentage of appointments attended Standard Deviation 40

Adverse Events

Music Therapy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samuel Rodgers-Melnick, MT-BC, music therapist

University Hospitals Connor Integrative Health Network

Phone: 216-844-7727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place