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Music Therapy in Sickle Cell Pain Mixed Methods Study

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ClinicalTrials.gov Identifier: NCT02270060
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : July 15, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Kulas Foundation
Information provided by (Responsible Party):
Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center

Study Description
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Brief Summary:

The purpose of this research study is to:

  1. Investigate the effects of a single 20-minute music therapy intervention with a music therapist on the pain intensity, pain relief, and mood of adult patients with sickle cell disease as compared to:

    1. Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)
    2. Adult patients with SCD who receive standard care alone (control group)
  2. Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Music Therapy Other: Music Listening Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Music Therapy Group
Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.
 Other: Music Therapy
Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.
Active Comparator: Music Listening Group
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
 Other: Music Listening
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
No Intervention: Control Group
Patient receives standard care and waits in treatment room/bay for twenty minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card [ Time Frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization ]
    Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.


Secondary Outcome Measures :
  1. Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card [ Time Frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization ]
    Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.

  2. Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card [ Time Frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization ]
    Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.

  3. Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card [ Time Frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization ]
    Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.

  4. Length of Stay in Minutes [ Time Frame: From time of admission into acute care clinic to time of discharge, up to 8 hours. ]
    Length of stay (in minutes) in acute care clinic

  5. Amount of Hydromorphone [ Time Frame: From time of admission into acute care clinic to time of discharge, up to 8 hours. ]
    Amount of Hydromorphone received in acute care clinic following intervention

  6. Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR) [ Time Frame: From time of admission into acute care clinic to time of discharge, up to 8 hours. ]
    Numeric pain rating between 0-10 before and after admission to acute care clinic. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have a diagnosis of sickle cell disease (HbSS, HbSC, HbSbeta+thal, or HbSbeta0thal)
  • 18 years or older
  • Able to speak and understand English

Exclusion Criteria:

  • Patients who have significant hearing impairments and/or significant visual impairments that have not been corrected
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270060


Locations
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United States, Ohio
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Kulas Foundation
Investigators
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Principal Investigator: Samuel N Rodgers-Melnick, MT-BC University Hospitals Cleveland Medical Center
More Information
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Additional Information:

Publications:

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Responsible Party: Samuel Rodgers-Melnick, Music Therapist, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02270060    
Other Study ID Numbers: 08-14-11
First Posted: October 21, 2014    Key Record Dates
Results First Posted: July 15, 2019
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center:
Music Therapy
Sickle Cell Disease
Pain
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn