Music Therapy in Sickle Cell Pain Mixed Methods Study

August 7, 2019 updated by: Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center

The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Seidman Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
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.
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
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.
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
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
From time of admission into acute care clinic to time of discharge, up to 8 hours.
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
From time of admission into acute care clinic to time of discharge, up to 8 hours.
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.
From time of admission into acute care clinic to time of discharge, up to 8 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Kulas Foundation

Investigators

  • Principal Investigator: Samuel N Rodgers-Melnick, MT-BC, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (ESTIMATE)

October 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-14-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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