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

Primary Purpose

Sickle Cell Disease, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Music Therapy, Sickle Cell Disease, Quality of Life, Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Seidman Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Therapy Group

Wait-List Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a
Physical function (4 questions)
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.
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a
Anxiety (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a
Depression (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a
Fatigue (4 questions)
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)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a
Pain interference (4 questions)

Secondary Outcome Measures

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.
Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD)
80-item questionnaire that assesses coping strategies relevant to SCD
Electronic Sickle Cell Disease Pain Diary
A multidimensional pain diary assessing daily pain intensity, location, description, cause, and interference with daily activities
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a
Sleep disturbance (4 questions)

Full Information

First Posted
May 22, 2018
Last Updated
May 2, 2019
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Kulas Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03556657
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Kulas Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Chronic Pain
Keywords
Music Therapy, Sickle Cell Disease, Quality of Life, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-List Control Group
Arm Type
No Intervention
Arm Description
Patient receives standard care alone. Patient will receive music therapy sessions following completion of the post-test.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a
Description
Physical function (4 questions)
Time Frame
Pre-test at baseline and post-test at 10 weeks
Title
Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)
Description
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
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a
Description
Anxiety (4 questions)
Time Frame
Pre-test at baseline and post-test at 10 weeks
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a
Description
Depression (4 questions)
Time Frame
Pre-test at baseline and post-test at 10 weeks
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a
Description
Fatigue (4 questions)
Time Frame
Pre-test at baseline and post-test at 10 weeks
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a
Description
Ability to participate in social roles and activities (4 questions)
Time Frame
Pre-test at baseline and post-test at 10 weeks
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a
Description
Pain interference (4 questions)
Time Frame
Pre-test at baseline and post-test at 10 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES)
Description
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
Title
Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD)
Description
80-item questionnaire that assesses coping strategies relevant to SCD
Time Frame
Pre-test at baseline and post-test at 10 weeks
Title
Electronic Sickle Cell Disease Pain Diary
Description
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
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a
Description
Sleep disturbance (4 questions)
Time Frame
Pre-test at baseline and post-test at 10 weeks
Other Pre-specified Outcome Measures:
Title
Semi-structured interview
Description
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.
Time Frame
At post-test at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel N Rodgers-Melnick, MT-BC
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.uhconnorintegrativehealth.org
Description
Website for UH Connor Integrative Health Network

Learn more about this trial

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

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