Music Therapy in Sickle Cell Pain Mixed Methods Study

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270060
• Other study ID #: 08-14-11
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2019
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Seidman Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Kulas Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Guétin S, Giniès P, Siou DK, Picot MC, Pommié 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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 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
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.	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.	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	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	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.	From time of admission into acute care clinic to time of discharge, up to 8 hours.

External Links

•   Website for UH Connor Integrative Health Network