Music Therapy in Sickle Cell Pain Mixed Methods Study

Not Applicable

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT02270060
• Lead Sponsor: University Hospitals Cleveland Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-21
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2018-11-01
• Results First Submitted QC: 2019-05-02
• Results First Posted: 2019-07-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card	Baseline and at end of 20-minute intervention, up to 120 minutes following randomization	Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.

Secondary Outcome Measures

Name	Time	Method
Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card	Baseline and at end of 20-minute intervention, up to 120 minutes following randomization	Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.
Length of Stay in Minutes	From time of admission into acute care clinic to time of discharge, up to 8 hours.	Length of stay (in minutes) in acute care clinic
Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card	Baseline and at end of 20-minute intervention, up to 120 minutes following randomization	Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.
Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)	From time of admission into acute care clinic to time of discharge, up to 8 hours.	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.
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card	Baseline and at end of 20-minute intervention, up to 120 minutes following randomization	Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.
Amount of Hydromorphone	From time of admission into acute care clinic to time of discharge, up to 8 hours.	Amount of Hydromorphone received in acute care clinic following intervention

Trial Locations

Locations (1)

University Hospitals Seidman Cancer Center; 🇺🇸 Cleveland, Ohio, United States