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| Name | Class |
|---|---|
| Kulas Foundation | OTHER |
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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:
Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Therapy Group | Experimental | 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 | Active Comparator | Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. |
|
| Control Group | No Intervention | Patient receives standard care and waits in treatment room/bay for twenty minutes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel N Rodgers-Melnick, MT-BC | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22001666 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Control Group | Patient receives standard care and waits in treatment room/bay for twenty minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who participated in the music therapy intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel Rodgers-Melnick, MT-BC, music therapist | University Hospitals Connor Integrative Health Network | 216-844-7727 | Samuel.RodgersMelnick@UHhospitals.org |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Music Listening | Other | Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. |
|
| 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. |
| Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
| 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. | Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
| Length of Stay in Minutes | Length of stay (in minutes) in acute care clinic | From time of admission into acute care clinic to time of discharge, up to 8 hours. |
| Amount of Hydromorphone | Amount of Hydromorphone received in acute care clinic following intervention | From time of admission into acute care clinic to time of discharge, up to 8 hours. |
| 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. | From time of admission into acute care clinic to time of discharge, up to 8 hours. |
| BG001 | 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. |
| BG002 | Control Group | Patient receives standard care and waits in treatment room/bay for twenty minutes. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of Sickle Cell Disease | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Control Group | Patient receives standard care and waits in treatment room/bay for twenty minutes. |
|
|
| 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. | All participants who participated in the music therapy intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
|
|
|
| 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. | All participants who participated in the music therapy intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
|
|
|
| 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. | All participants who participated in the music therapy intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at end of 20-minute intervention, up to 120 minutes following randomization |
|
|
|
| Secondary | Length of Stay in Minutes | Length of stay (in minutes) in acute care clinic | All participants who participated in the music therapy intervention. | Posted | Mean | Standard Deviation | minutes | From time of admission into acute care clinic to time of discharge, up to 8 hours. |
|
|
|
| Secondary | Amount of Hydromorphone | Amount of Hydromorphone received in acute care clinic following intervention | All participants who participated in the music therapy intervention and received hydromorphone. | Posted | Mean | Standard Deviation | milligrams | From time of admission into acute care clinic to time of discharge, up to 8 hours. |
|
|
|
| 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. | All participants who participated in the music therapy intervention. | Posted | Mean | Standard Deviation | score on a scale | From time of admission into acute care clinic to time of discharge, up to 8 hours. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Control Group | Patient receives standard care and waits in treatment room/bay for twenty minutes. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |