Music Therapy in Sickle Cell Pain Mixed Methods Study

• ClinicalTrials.gov Identifier: NCT02270060
• Recruitment Status: Completed
• First Posted: October 21, 2014
• Results First Posted: July 15, 2019
• Last Update Posted: August 21, 2019
• Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Kulas Foundation
• Information provided by (Responsible Party): Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center

Tracking Information

• First Submitted Date: October 10, 2014
• First Posted Date: October 21, 2014
• Results First Submitted Date: November 1, 2018
• Results First Posted Date: July 15, 2019
• Last Update Posted Date: August 21, 2019
• Study Start Date: September 2014
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2019)

Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card [ Time Frame: 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.

Original Primary Outcome Measures (submitted: October 20, 2014)

Change from baseline in VASPI of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 30 minutes following randomization ]

VAS of Pain Intensity

Current Secondary Outcome Measures (submitted: May 2, 2019)

• Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card [ Time Frame: 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.
• Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card [ Time Frame: 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.
• Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card [ Time Frame: 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.
• Length of Stay in Minutes [ Time Frame: 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
• Amount of Hydromorphone [ Time Frame: 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
• Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR) [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: October 20, 2014)

• Change from baseline in VASPR of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 30 minutes following randomization ]
  VAS of Pain Relief
• Change from baseline in VASMOOD of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 30 minutes following randomization ]
  VAS of Mood
• Change from baseline in Tursky scale of Memorial Pain Assessment Card [ Time Frame: At end of 20-minute intervention, up to 30 minutes following randomization ]
  Pain Adjectives Scale
• Length of Stay [ Time Frame: From time of admission into acute care clinic to time of discharge, up to 8 hours. ]
  Length of stay in acute care clinic
• Amount of Narcotics [ Time Frame: From time of admission into acute care clinic to time of discharge, up to 8 hours. ]
  Amount of narcotics received in acute care clinic following intervention
• Change from baseline in Numeric Pain Rating (NPR) [ Time Frame: 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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.
• Other: Music Listening
  Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.

Study Arms

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 6, 2016): 60
• Original Estimated Enrollment (submitted: October 20, 2014): 120
• Actual Study Completion Date: May 2016
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02270060
• Other Study ID Numbers: 08-14-11
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospitals Cleveland Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Kulas Foundation

Investigators

• Principal Investigator: Samuel N Rodgers-Melnick, MT-BC; University Hospitals Cleveland Medical Center

• PRS Account: University Hospitals Cleveland Medical Center
• Verification Date: August 2019