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Music Therapy in Sickle Cell Pain Mixed Methods Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Interventions Other: Music Therapy
Other: Music Listening
Enrollment 60
Recruitment Details  
Pre-assignment Details Following verbal consent on the day of an ACC visit, an RN escorted the participant into the ACC to receive standard care that included vital signs, a lab draw, assessment by a nurse practitioner, and scheduled analgesics. The assigned study condition occurred one hour after participants' first dose of analgesics.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Period Title: Overall Study
Started 20 20 20
Completed 20 20 20
Not Completed 0 0 0
Arm/Group Title Music Therapy Group Music Listening Group Control Group Total
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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. Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 60 participants
30.85  (9.49) 33.25  (11.23) 30.60  (7.44) 31.57  (9.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
12
  60.0%
11
  55.0%
12
  60.0%
35
  58.3%
Male
8
  40.0%
9
  45.0%
8
  40.0%
25
  41.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 60 participants
20 20 20 60
Type of Sickle Cell Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
HbSS
10
  50.0%
15
  75.0%
12
  60.0%
37
  61.7%
HbSC
6
  30.0%
4
  20.0%
5
  25.0%
15
  25.0%
HbSbeta+ Thalassemia
3
  15.0%
0
   0.0%
3
  15.0%
6
  10.0%
HbSbeta0 Thalassemia
1
   5.0%
1
   5.0%
0
   0.0%
2
   3.3%
1.Primary Outcome
Title Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who participated in the music therapy intervention.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.92  (1.88) -1.92  (2.50) -1.19  (1.69)
2.Secondary Outcome
Title Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who participated in the music therapy intervention.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.05  (2.33) .86  (4.01) .45  (1.97)
3.Secondary Outcome
Title Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who participated in the music therapy intervention.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.33  (2.10) .96  (2.38) .74  (1.98)
4.Secondary Outcome
Title Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who participated in the music therapy intervention.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.80  (1.20) -0.35  (2.23) -0.50  (1.00)
5.Secondary Outcome
Title Length of Stay in Minutes
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who participated in the music therapy intervention.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: minutes
272.95  (72.84) 286.80  (116.74) 287.45  (119.75)
6.Secondary Outcome
Title Amount of Hydromorphone
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who participated in the music therapy intervention and received hydromorphone.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Overall Number of Participants Analyzed 19 18 18
Mean (Standard Deviation)
Unit of Measure: milligrams
10.30  (7.84) 8.10  (6.70) 10.00  (8.25)
7.Secondary Outcome
Title Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who participated in the music therapy intervention.
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.70  (1.63) -2.95  (1.68) -3.10  (1.97)
Time Frame Adverse event data were collected over the 20 month study period. For each participant, adverse event data was collected between baseline measurement of clinical outcomes and the end of each participant's participation in the study in the acute care clinic. This duration varied between 2 and 6 hours for each participant depending on his/her length of stay.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Music Therapy Group Music Listening Group Control Group
Hide Arm/Group 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.

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.

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Music Listening: 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.
All-Cause Mortality
Music Therapy Group Music Listening Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Music Therapy Group Music Listening Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Music Therapy Group Music Listening Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Small sample size and potential risk of bias, due to some participants having previous clinical relationships with the investigators prior to study initiation. We were unable to blind participants to their study condition assignments.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Samuel Rodgers-Melnick, MT-BC, music therapist
Organization: University Hospitals Connor Integrative Health Network
Phone: 216-844-7727
EMail: Samuel.RodgersMelnick@UHhospitals.org
Layout table for additonal information
Responsible Party: Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02270060    
Other Study ID Numbers: 08-14-11
First Submitted: October 10, 2014
First Posted: October 21, 2014
Results First Submitted: November 1, 2018
Results First Posted: July 15, 2019
Last Update Posted: August 21, 2019