Sickle Cell DiseaseNCT03556657
MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS)
A study testing Music Therapy in people with Sickle Cell Disease and Chronic Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Chronic Pain
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: 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.
- Conditions
- Sickle Cell Disease, Chronic Pain
- Being tested
- Music Therapy
- Keywords
- Music Therapy, Sickle Cell Disease, Quality of Life, Chronic Pain
- Medical subject headings
- Anemia, Sickle Cell, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a
Physical function (4 questions)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Pre-test at baseline and post-test at 10 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: Pre-test at baseline and post-test at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start27 Aug 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kulas Foundation
- Responsible party
- Principal investigator, Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
- Investigators
- Samuel N Rodgers-Melnick, MT-BC, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556657
- Sponsor's protocol ID
- STUDY20180101
- Status last verified
- May 2019
- First submitted
- 22 May 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS): A Pilot Study
- ClinicalTrials.gov ID
- NCT03556657
- Acronym / sponsor ID
- STUDY20180101
- Conditions
- Sickle Cell Disease, Chronic Pain
- Keywords
- Music Therapy, Sickle Cell Disease, Quality of Life, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Kulas Foundation
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Group | Experimental | Other: Music TherapyPatient 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. |
| Wait-List Control Group | No intervention | –Patient receives standard care alone. Patient will receive music therapy sessions following completion of the post-test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyPatient 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 Group |
Primary outcome
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a
Time frame: Pre-test at baseline and post-test at 10 weeks
Physical function (4 questions)
Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)
Time frame: Pre-test at baseline and post-test at 10 weeks
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
Time frame: Pre-test at baseline and post-test at 10 weeks
Anxiety (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a
Time frame: Pre-test at baseline and post-test at 10 weeks
Depression (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a
Time frame: Pre-test at baseline and post-test at 10 weeks
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
Time frame: Pre-test at baseline and post-test at 10 weeks
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
Time frame: Pre-test at baseline and post-test at 10 weeks
Pain interference (4 questions)
4 secondary outcomes
Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES)
Time frame: Pre-test at baseline and post-test at 10 weeks
Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD)
Time frame: Pre-test at baseline and post-test at 10 weeks
Electronic Sickle Cell Disease Pain Diary
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
Time frame: Pre-test at baseline and post-test at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel N Rodgers-Melnick, MT-BC principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Sickle Cell Disease and Chronic Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a (time frame: Pre-test at baseline and post-test at 10 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.