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| Name | Class |
|---|---|
| Kulas Foundation | OTHER |
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The purpose of this pilot study is to investigate the effects of a 6-session music therapy protocol on the pain, mood, quality of life, coping skills, and self-efficacy of adult patients with sickle cell disease (SCD) as compared to adult patients with SCD who receive standard care alone. The investigators will also determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Therapy Group | Experimental | Patient receives 6 sessions of music therapy with a board-certified music therapist. Patient will learn various music interventions for pain management that he/she will utilize at home. |
|
| Wait-List Control Group | No Intervention | Patient receives standard care alone. Patient will receive music therapy sessions following completion of the post-test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy | Other | Patient receives 6 sessions of music therapy with a board-certified music therapist. Patient will learn various music interventions for pain management that he/she will utilize at home. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a | Physical function (4 questions) | Pre-test at baseline and post-test at 10 weeks |
| Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) | A patient-reported outcome measurement system that addresses the physical, social, and emotional impact of SCD. ASCQ-Me scores are calculated in the direction of overall health, with higher ASCQ-Me scores indicating better health. | Pre-test at baseline and post-test at 10 weeks |
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a | Anxiety (4 questions) | Pre-test at baseline and post-test at 10 weeks |
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a | Depression (4 questions) | Pre-test at baseline and post-test at 10 weeks |
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a | Fatigue (4 questions) | Pre-test at baseline and post-test at 10 weeks |
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a | Ability to participate in social roles and activities (4 questions) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES) | A nine-item Likert scale originally developed for adults with SCD to assess patients' beliefs in their ability to manage their own SCD. | Pre-test at baseline and post-test at 10 weeks |
| Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD) |
| Measure | Description | Time Frame |
|---|---|---|
| Semi-structured interview | Interview questions will focus on the patient's current pain, his/her experience of the music therapy sessions, and whether anything could have been done differently to improve the music therapy sessions. | At post-test at 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel N Rodgers-Melnick, MT-BC | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Pre-test at baseline and post-test at 10 weeks |
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a | Pain interference (4 questions) | Pre-test at baseline and post-test at 10 weeks |
80-item questionnaire that assesses coping strategies relevant to SCD |
| Pre-test at baseline and post-test at 10 weeks |
| Electronic Sickle Cell Disease Pain Diary | A multidimensional pain diary assessing daily pain intensity, location, description, cause, and interference with daily activities | Daily entries for 2 weeks at baseline and daily entries for 2 weeks post-intervention |
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a | Sleep disturbance (4 questions) | Pre-test at baseline and post-test at 10 weeks |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |