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NCT Number: NCT03556657

MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS)

The purpose of this pilot study is to investigate the effects of a 6-session music therapy protocol on the pain, mood, quality of life, coping skills, and self-efficacy of adult patients with sickle cell disease (SCD) as compared to adult patients with SCD who receive standard care alone. The investigators will also determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management and quality of life.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Chronic Pain 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

  • Subject is 18 years or older
  • Subject has a SCD diagnosis
  • Subject fits chronic pain criteria in SCD
  • Subject has a working email address
  • Subject has access to a mobile device with email and internet capabilities
  • Subject is able to speak and understand English
  • Subject has attended at least 50% of his/her scheduled outpatient visits to the Adult SCD Clinic in the last 12 months

Exclusion criteria

  • Subject has a significant visual impairment that has not been corrected
  • Subject has a significant hearing impairment that has not been corrected
  • Subject has a significant cognitive impairment that would prevent subject from participating in the study

Treatment and study plan

Music Therapy

Other

Patient receives 6 sessions of music therapy with a board-certified music therapist. Patient will learn various music interventions for pain management that he/she will utilize at home.

Primary outcomes

  1. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a

    Time frame: Pre-test at baseline and post-test at 10 weeks

    Physical function (4 questions)

  2. Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)

    Time frame: Pre-test at baseline and post-test at 10 weeks

    A patient-reported outcome measurement system that addresses the physical, social, and emotional impact of SCD. ASCQ-Me scores are calculated in the direction of overall health, with higher ASCQ-Me scores indicating better health.

  3. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a

    Time frame: Pre-test at baseline and post-test at 10 weeks

    Anxiety (4 questions)

  4. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a

    Time frame: Pre-test at baseline and post-test at 10 weeks

    Depression (4 questions)

  5. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a

    Time frame: Pre-test at baseline and post-test at 10 weeks

    Fatigue (4 questions)

  6. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a

    Time frame: Pre-test at baseline and post-test at 10 weeks

    Ability to participate in social roles and activities (4 questions)

  7. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a

    Time frame: Pre-test at baseline and post-test at 10 weeks

    Pain interference (4 questions)

Secondary outcomes

  1. Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES)

    Time frame: Pre-test at baseline and post-test at 10 weeks

    A nine-item Likert scale originally developed for adults with SCD to assess patients' beliefs in their ability to manage their own SCD.

  2. Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD)

    Time frame: Pre-test at baseline and post-test at 10 weeks

    80-item questionnaire that assesses coping strategies relevant to SCD

  3. Electronic Sickle Cell Disease Pain Diary

    Time frame: Daily entries for 2 weeks at baseline and daily entries for 2 weeks post-intervention

    A multidimensional pain diary assessing daily pain intensity, location, description, cause, and interference with daily activities

  4. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a

    Time frame: Pre-test at baseline and post-test at 10 weeks

    Sleep disturbance (4 questions)

Other outcomes

  1. Semi-structured interview

    Time frame: At post-test at 10 weeks

    Interview questions will focus on the patient's current pain, his/her experience of the music therapy sessions, and whether anything could have been done differently to improve the music therapy sessions.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Kulas Foundation

Registry information

Official study title

MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS): A Pilot Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2018
Registry last updated
May 6, 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.

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