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

University Hospitals Cleveland Medical Center24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sickle Cell Disease Chronic Pain

Interventions

Music TherapyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a

Physical function (4 questions)

Time frame: 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.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Pre-test at baseline and post-test at 10 weeks