Music Therapy in Sickle Cell Pain Mixed Methods Study
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
Music Listening
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Music Therapy, Sickle Cell Disease, Pain
Eligibility 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
Sites / Locations
- University Hospitals Seidman Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Music Therapy Group
Music Listening Group
Control Group
Arm Description
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.
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
Patient receives standard care and waits in treatment room/bay for twenty minutes.
Outcomes
Primary Outcome Measures
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
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
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card
Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.
Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card
Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.
Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card
Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.
Length of Stay in Minutes
Length of stay (in minutes) in acute care clinic
Amount of Hydromorphone
Amount of Hydromorphone received in acute care clinic following intervention
Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)
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.
Full Information
NCT ID
NCT02270060
First Posted
October 10, 2014
Last Updated
August 7, 2019
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Kulas Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02270060
Brief Title
Music Therapy in Sickle Cell Pain Mixed Methods Study
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 Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to:
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:
Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)
Adult patients with SCD who receive standard care alone (control group)
Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Music Therapy, Sickle Cell Disease, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Music Listening Group
Arm Type
Active Comparator
Arm Description
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patient receives standard care and waits in treatment room/bay for twenty minutes.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Music Listening
Intervention Description
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
Primary Outcome Measure Information:
Title
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
Description
Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.
Time Frame
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Secondary Outcome Measure Information:
Title
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card
Description
Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.
Time Frame
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Title
Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card
Description
Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.
Time Frame
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Title
Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card
Description
Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.
Time Frame
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Title
Length of Stay in Minutes
Description
Length of stay (in minutes) in acute care clinic
Time Frame
From time of admission into acute care clinic to time of discharge, up to 8 hours.
Title
Amount of Hydromorphone
Description
Amount of Hydromorphone received in acute care clinic following intervention
Time Frame
From time of admission into acute care clinic to time of discharge, up to 8 hours.
Title
Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)
Description
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.
Time Frame
From time of admission into acute care clinic to time of discharge, up to 8 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22001666
Citation
Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
Results Reference
background
Links:
URL
http://www.uhconnorintegrativehealth.org
Description
Website for UH Connor Integrative Health Network
Learn more about this trial
Music Therapy in Sickle Cell Pain Mixed Methods Study
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