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

NCT03556657 | Completed DMC

• 1 other identifier: STUDY20180101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Chronic Pain

Keywords

Music Therapy; Sickle Cell Disease; Quality of Life; Chronic Pain

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES)

  Pre-test at baseline and post-test at 10 weeks

• Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD)

  Pre-test at baseline and post-test at 10 weeks

• Electronic Sickle Cell Disease Pain Diary

  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

  Pre-test at baseline and post-test at 10 weeks

Other Outcomes (1)

• Semi-structured interview

  At post-test at 10 weeks

Study Arms (2)

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.

Other: Music Therapy

Wait-List Control Group

NO INTERVENTION

Patient receives standard care alone. Patient will receive music therapy sessions following completion of the post-test.

Interventions

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.

Music Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Kulas Foundation: collaborator

Study Sites (1)

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Chronic Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Samuel N Rodgers-Melnick, MT-BC

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Music Therapist

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 14, 2018
• Study Start: August 27, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

US (1)