The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
研究概览
简要总结
The purpose of this research study is to:
-
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:
-
Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)
-
Adult patients with SCD who receive standard care alone (control group)
-
Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management
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
- •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
排除标准
- •Patients who have significant hearing impairments and/or significant visual impairments that have not been corrected
研究组 & 干预措施
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.
干预措施: Music Therapy (Other)
Music Listening Group
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
干预措施: Music Listening (Other)
Control Group
Patient receives standard care and waits in treatment room/bay for twenty minutes.
结局指标
主要结局
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
时间窗: 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.
次要结局
- 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)
- Length of Stay in Minutes(From time of admission into acute care clinic to time of discharge, up to 8 hours.)
- 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)
- Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)(From time of admission into acute care clinic to time of discharge, up to 8 hours.)
- 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)
- Amount of Hydromorphone(From time of admission into acute care clinic to time of discharge, up to 8 hours.)
研究者
Samuel Rodgers-Melnick
Music Therapist
University Hospitals Cleveland Medical Center