Music Therapy in Sickle Cell Pain Mixed Methods Study

• 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: University Hospitals Cleveland Medical Center
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Music Therapy Group	Music Listening Group	Control Group	Total
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
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%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group	Music Listening Group	Control Group
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
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

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group	Music Listening Group	Control Group
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
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

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group	Music Listening Group	Control Group
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
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

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group	Music Listening Group	Control Group
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
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.

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group	Music Listening Group	Control Group
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
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.

Outcome Measure Data

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
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)
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.

Outcome Measure Data

Analysis Population Description

All participants who participated in the music therapy intervention.

Arm/Group Title	Music Therapy Group	Music Listening Group	Control Group
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)

Adverse Events

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
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%)
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%)
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%)

Limitations and Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• 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

Publications:

Guétin S, Giniès P, Siou DK, Picot MC, Pommié 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.

• 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