Skip to main content
OpenTrials
Completed

NCT Number: NCT02270060

Music Therapy in Sickle Cell Pain Mixed Methods Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 listening

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Kulas Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2014
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.