Music Therapy in Sickle Cell Pain Mixed Methods Study

NCT02270060 | Completed Results DMC

• 1 other identifier: 08-14-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to:

1. 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:
2. 2.Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)
3. 3.Adult patients with SCD who receive standard care alone (control group)
4. 4.Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management

Conditions

Sickle Cell Disease

Keywords

Music Therapy; Sickle Cell Disease; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• Length of Stay in Minutes

  From time of admission into acute care clinic to time of discharge, up to 8 hours.

• Amount of Hydromorphone

  From time of admission into acute care clinic to time of discharge, up to 8 hours.

Study Arms (3)

Music Therapy Group

EXPERIMENTAL

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 Therapy

Music Listening Group

ACTIVE COMPARATOR

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

Other: Music Listening

Control Group

NO INTERVENTION

Patient receives standard care and waits in treatment room/bay for twenty minutes.

Interventions

Music Therapy 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 Therapy Group

Music Listening OTHER

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

Music Listening Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have a diagnosis of sickle cell disease (HbSS, HbSC, HbSbeta+thal, or HbSbeta0thal)
• years or older
• Able to speak and understand English

You may not qualify if:

• Patients who have significant hearing impairments and/or significant visual impairments that have not been corrected

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Kulas Foundation: collaborator

Study Sites (1)

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 22001666 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Small sample size and potential risk of bias, due to some participants having previous clinical relationships with the investigators prior to study initiation. We were unable to blind participants to their study condition assignments.

Results Point of Contact

• Title: Samuel Rodgers-Melnick, MT-BC, music therapist
• Organization: University Hospitals Connor Integrative Health Network

Samuel.RodgersMelnick@UHhospitals.org

216-844-7727

Study Officials

• Samuel N Rodgers-Melnick, MT-BC

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Music Therapist

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 21, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 21, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-08

Locations

US (1)