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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556657
• Other study ID #: STUDY20180101
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2019
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Chronic Pain
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Seidman Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Kulas Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Website for UH Connor Integrative Health Network