Music Therapy in Sickle Cell Pain Mixed Methods Study

Study Overview
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Brief Summary
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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: Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group) Adult patients with SCD who receive standard care alone (control group) Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management

Official Title
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The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Other: Music Therapy
* Other: Music Listening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy Group<br>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. | Other: Music Therapy<br>* 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.<br>|
| Active Comparator: Music Listening Group<br>Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. | Other: Music Listening<br>* Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.<br>|
| No Intervention: Control Group<br>Patient receives standard care and waits in treatment room/bay for twenty minutes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music Therapy, Sickle Cell Disease, Pain