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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
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
Kulas Foundation
Information provided by (Responsible Party):
Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center

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 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


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.



Primary Outcome Measures :
  1. Change from baseline in VASPI of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 120 minutes following randomization ]
    VAS of Pain Intensity


Secondary Outcome Measures :
  1. Change from baseline in VASPR of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 120 minutes following randomization ]
    VAS of Pain Relief

  2. Change from baseline in VASMOOD of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 120 minutes following randomization ]
    VAS of Mood

  3. Change from baseline in Tursky scale of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 120 minutes following randomization ]
    Pain Adjectives Scale

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

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

  6. Change 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


Other Outcome Measures:
  1. Semi-Structured Interview [ Time Frame: At end of 20-minute intervention, up to 120 minutes following randomization ]
    Interview questions will focus on the patient's current pain, his/her experience of the music session, and whether anything could have been done differently to improve the music session.



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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

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

Additional Information:
Publications:
Responsible Party: Samuel Rodgers-Melnick, Music Therapist, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02270060     History of Changes
Other Study ID Numbers: 08-14-11
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
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:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn