Clinical trial NCT02270060: Music Therapy in Sickle Cell Pain Mixed Methods Study
Official title: The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Music Therapy
Sickle Cell Disease
Pain
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Kulas Foundation
First posted: 2014-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
timeFrame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Secondary outcomes:
measure: Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card
timeFrame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
measure: Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card
timeFrame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
measure: Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card
timeFrame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
measure: Length of Stay in Minutes
timeFrame: From time of admission into acute care clinic to time of discharge, up to 8 hours.
measure: Amount of Hydromorphone
timeFrame: From time of admission into acute care clinic to time of discharge, up to 8 hours.
measure: Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)
timeFrame: From time of admission into acute care clinic to time of discharge, up to 8 hours.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Samuel N Rodgers-Melnick, MT-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.