MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS)

MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS): A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Sickle Cell Disease
• Intervention / Treatment: Other: Music Therapy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Seidman Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Music Therapy Group; 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.	Other: Music Therapy; 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.
NO_INTERVENTION: Wait-List Control Group; Patient receives standard care alone. Patient will receive music therapy sessions following completion of the post-test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Kulas Foundation
• Investigators: Principal Investigator: Samuel N Rodgers-Melnick, MT-BC, University Hospitals Cleveland Medical Center

Publications and helpful links

Helpful Links

• Website for UH Connor Integrative Health Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 27, 2018
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (ACTUAL): June 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Chronic Pain; Sickle Cell Disease; Music Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Chronic Pain; Anemia, Sickle Cell
• Other Study ID Numbers: STUDY20180101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No