Clinical trial NCT03556657: MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS)
Official title: MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Chronic Pain
Keywords: Music Therapy
Sickle Cell Disease
Quality of Life
Chronic Pain
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Kulas Foundation
First posted: 2018-06-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older
* Subject has a SCD diagnosis
* Subject fits chronic pain criteria in SCD
* Subject has a working email address
* Subject has access to a mobile device with email and internet capabilities
* Subject is able to speak and understand English
* Subject has attended at least 50% of his/her scheduled outpatient visits to the Adult SCD Clinic in the last 12 months

Exclusion Criteria:

* Subject has a significant visual impairment that has not been corrected
* Subject has a significant hearing impairment that has not been corrected
* Subject has a significant cognitive impairment that would prevent subject from participating in the study

Primary outcomes:
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a
timeFrame: Pre-test at baseline and post-test at 10 weeks
Secondary outcomes:
measure: Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES)
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD)
timeFrame: Pre-test at baseline and post-test at 10 weeks
measure: Electronic Sickle Cell Disease Pain Diary
timeFrame: Daily entries for 2 weeks at baseline and daily entries for 2 weeks post-intervention
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a
timeFrame: Pre-test at baseline and post-test at 10 weeks
Other outcomes:
measure: Semi-structured interview
timeFrame: At post-test at 10 weeks
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Samuel N Rodgers-Melnick, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: