Sickle Cell Disease
Conditions
Keywords
Music Therapy, Sickle Cell Disease, Pain
Brief summary
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
Interventions
OTHERMusic 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.
OTHERMusic Listening
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
Sponsors
Kulas Foundation
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card | 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. |
| Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card | 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. |
| Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card | 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. |
| Amount of Hydromorphone | 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 |
| Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR) | 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. |
| Length of Stay in Minutes | 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 |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Control Group Patient receives standard care and waits in treatment room/bay for twenty minutes. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Music Therapy Group | Music Listening Group | Control Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Age, Continuous | 30.85 years STANDARD_DEVIATION 9.49 | 33.25 years STANDARD_DEVIATION 11.23 | 30.60 years STANDARD_DEVIATION 7.44 | 31.57 years STANDARD_DEVIATION 9.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 12 Participants | 35 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 8 Participants | 25 Participants |
| Type of Sickle Cell Disease HbSbeta0 Thalassemia | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Type of Sickle Cell Disease HbSbeta+ Thalassemia | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Type of Sickle Cell Disease HbSC | 6 Participants | 4 Participants | 5 Participants | 15 Participants |
| Type of Sickle Cell Disease HbSS | 10 Participants | 15 Participants | 12 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Population: All participants who participated in the music therapy intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy Group | 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 |
| Music Listening Group | 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 2.5 |
| Control Group | Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card | -1.19 score on a scale | Standard Deviation 1.69 |
Secondary
Amount of Hydromorphone
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.
Population: All participants who participated in the music therapy intervention and received hydromorphone.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy Group | Amount of Hydromorphone | 10.30 milligrams | Standard Deviation 7.84 |
| Music Listening Group | Amount of Hydromorphone | 8.10 milligrams | Standard Deviation 6.7 |
| Control Group | Amount of Hydromorphone | 10.00 milligrams | Standard Deviation 8.25 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy Group | Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR) | -2.70 score on a scale | Standard Deviation 1.63 |
| Music Listening Group | Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR) | -2.95 score on a scale | Standard Deviation 1.68 |
| Control Group | Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR) | -3.10 score on a scale | Standard Deviation 1.97 |
Secondary
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.
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Population: All participants who participated in the music therapy intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy Group | Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card | -0.80 score on a scale | Standard Deviation 1.2 |
| Music Listening Group | Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card | -0.35 score on a scale | Standard Deviation 2.23 |
| Control Group | Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card | -0.50 score on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Population: All participants who participated in the music therapy intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy Group | 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 2.1 |
| Music Listening Group | Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card | .96 score on a scale | Standard Deviation 2.38 |
| Control Group | Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card | .74 score on a scale | Standard Deviation 1.98 |
Secondary
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.
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Population: All participants who participated in the music therapy intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy Group | 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 |
| Music Listening Group | Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card | .86 score on a scale | Standard Deviation 4.01 |
| Control Group | Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card | .45 score on a scale | Standard Deviation 1.97 |
Secondary
Length of Stay in Minutes
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.
Population: All participants who participated in the music therapy intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy Group | Length of Stay in Minutes | 272.95 minutes | Standard Deviation 72.84 |
| Music Listening Group | Length of Stay in Minutes | 286.80 minutes | Standard Deviation 116.74 |
| Control Group | Length of Stay in Minutes | 287.45 minutes | Standard Deviation 119.75 |