Music Therapy in Sickle Cell Pain Mixed Methods Study

NCT ID: NCT02270060

Last Updated: 2019-08-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type 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.

Music Listening Group

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Group Type ACTIVE_COMPARATOR

Music Listening

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Music Listening

Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kulas Foundation

OTHER

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samuel Rodgers-Melnick

Music Therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel N Rodgers-Melnick, MT-BC

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22001666 (View on PubMed)

Other Identifiers

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08-14-11

Identifier Type: -

Identifier Source: org_study_id

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