Trial Outcomes & Findings for Music Therapy in Sickle Cell Pain Mixed Methods Study (NCT NCT02270060)
NCT ID: NCT02270060
Last Updated: 2019-08-21
Results Overview
Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Results posted on
2019-08-21
Participant Flow
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.
Participant milestones
| Measure |
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.
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.
|
Music Listening Group
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.
|
Control Group
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Music Therapy in Sickle Cell Pain Mixed Methods Study
Baseline characteristics by cohort
| Measure |
Music Therapy Group
n=20 Participants
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.
|
Music Listening Group
n=20 Participants
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.
|
Control Group
n=20 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
30.85 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
33.25 years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
30.60 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
31.57 years
STANDARD_DEVIATION 9.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Type of Sickle Cell Disease
HbSS
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Type of Sickle Cell Disease
HbSC
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Type of Sickle Cell Disease
HbSbeta+ Thalassemia
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Type of Sickle Cell Disease
HbSbeta0 Thalassemia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and at end of 20-minute intervention, up to 120 minutes following randomizationPopulation: All participants who participated in the music therapy intervention.
Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.
Outcome measures
| Measure |
Music Therapy Group
n=20 Participants
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.
|
Music Listening Group
n=20 Participants
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.
|
Control Group
n=20 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
|
-1.92 score on a scale
Standard Deviation 1.88
|
-1.92 score on a scale
Standard Deviation 2.50
|
-1.19 score on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Baseline and at end of 20-minute intervention, up to 120 minutes following randomizationPopulation: All participants who participated in the music therapy intervention.
Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.
Outcome measures
| Measure |
Music Therapy Group
n=20 Participants
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.
|
Music Listening Group
n=20 Participants
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.
|
Control Group
n=20 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card
|
2.05 score on a scale
Standard Deviation 2.33
|
.86 score on a scale
Standard Deviation 4.01
|
.45 score on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Baseline and at end of 20-minute intervention, up to 120 minutes following randomizationPopulation: All participants who participated in the music therapy intervention.
Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.
Outcome measures
| Measure |
Music Therapy Group
n=20 Participants
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.
|
Music Listening Group
n=20 Participants
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.
|
Control Group
n=20 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card
|
2.33 score on a scale
Standard Deviation 2.10
|
.96 score on a scale
Standard Deviation 2.38
|
.74 score on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline and at end of 20-minute intervention, up to 120 minutes following randomizationPopulation: All participants who participated in the music therapy intervention.
Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.
Outcome measures
| Measure |
Music Therapy Group
n=20 Participants
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.
|
Music Listening Group
n=20 Participants
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.
|
Control Group
n=20 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card
|
-0.80 score on a scale
Standard Deviation 1.20
|
-0.35 score on a scale
Standard Deviation 2.23
|
-0.50 score on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: From time of admission into acute care clinic to time of discharge, up to 8 hours.Population: All participants who participated in the music therapy intervention.
Length of stay (in minutes) in acute care clinic
Outcome measures
| Measure |
Music Therapy Group
n=20 Participants
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.
|
Music Listening Group
n=20 Participants
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.
|
Control Group
n=20 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Length of Stay in Minutes
|
272.95 minutes
Standard Deviation 72.84
|
286.80 minutes
Standard Deviation 116.74
|
287.45 minutes
Standard Deviation 119.75
|
SECONDARY outcome
Timeframe: From time of admission into acute care clinic to time of discharge, up to 8 hours.Population: All participants who participated in the music therapy intervention and received hydromorphone.
Amount of Hydromorphone received in acute care clinic following intervention
Outcome measures
| Measure |
Music Therapy Group
n=19 Participants
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.
|
Music Listening Group
n=18 Participants
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.
|
Control Group
n=18 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Amount of Hydromorphone
|
10.30 milligrams
Standard Deviation 7.84
|
8.10 milligrams
Standard Deviation 6.70
|
10.00 milligrams
Standard Deviation 8.25
|
SECONDARY outcome
Timeframe: From time of admission into acute care clinic to time of discharge, up to 8 hours.Population: All participants who participated in the music therapy intervention.
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.
Outcome measures
| Measure |
Music Therapy Group
n=20 Participants
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.
|
Music Listening Group
n=20 Participants
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.
|
Control Group
n=20 Participants
Patient receives standard care and waits in treatment room/bay for twenty minutes.
|
|---|---|---|---|
|
Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)
|
-2.70 score on a scale
Standard Deviation 1.63
|
-2.95 score on a scale
Standard Deviation 1.68
|
-3.10 score on a scale
Standard Deviation 1.97
|
Adverse Events
Music Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Music Listening Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Samuel Rodgers-Melnick, MT-BC, music therapist
University Hospitals Connor Integrative Health Network
Phone: 216-844-7727
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place