MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Music Therapy Group
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.
干预措施: Music Therapy (Other)
Wait-List Control Group
Patient receives standard care alone. Patient will receive music therapy sessions following completion of the post-test.
结局指标
主要结局
Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)
时间窗: 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.
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a
时间窗: Pre-test at baseline and post-test at 10 weeks
Anxiety (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a
时间窗: Pre-test at baseline and post-test at 10 weeks
Physical function (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a
时间窗: Pre-test at baseline and post-test at 10 weeks
Depression (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a
时间窗: Pre-test at baseline and post-test at 10 weeks
Fatigue (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a
时间窗: Pre-test at baseline and post-test at 10 weeks
Ability to participate in social roles and activities (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a
时间窗: Pre-test at baseline and post-test at 10 weeks
Pain interference (4 questions)
次要结局
- Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES)(Pre-test at baseline and post-test at 10 weeks)
- Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD)(Pre-test at baseline and post-test at 10 weeks)
- Electronic Sickle Cell Disease Pain Diary(Daily entries for 2 weeks at baseline and daily entries for 2 weeks post-intervention)
- Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a(Pre-test at baseline and post-test at 10 weeks)
研究者
Samuel Rodgers-Melnick
Music Therapist
University Hospitals Cleveland Medical Center