Music Therapy for Hospitalized Patients With Parkinson's Disease and Lewy Body Dementia: A Randomized Controlled Pilot Trial to Prevent Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Confusion Assessment Measure (CAM)
研究概览
简要总结
The goal of this clinical trial is to test whether a music therapy intervention (MT) prevents hospital-acquired delirium (HaD) in patients with Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB). Delirium is defined as a mental state in which you are confused, disoriented, and not able to think or remember clearly. It can start suddenly and is usually temporary. It is common among patients with PD/DLB during hospitalization.
We are conducting a randomized controlled feasibility pilot study of music therapy (MT) in patients with PD/DLB in the inpatient acute hospital setting.
We are testing if receiving music therapy lowers the risk of delirium, compared to other interventions. We are also testing if music therapy lowers the need for certain restraints and medications during the hospitalization.
Participants admitted to UMass Memorial Medical Center will be invited to participate. Participants will be asked to undergo a music therapy intervention for 30 minutes 3 times per week, and to listen to personalized music playlists for 60 minutes 4 times per week. Participants will be assessed for HaD every 24 hours, and will undergo additional surveys and questionnaires.
Researchers will compare the music therapy intervention to two another comparison groups: one group assigned to listen to music on their own, and one group assigned to receive only standard treatments. About one-third of the participants will be assigned to each of the three study groups.
详细描述
Participants will be screened within 24 hours of inpatient admission to UMass Memorial Medical Center, University Campus (Worcester, MA).
Participants will be randomized equally to one of three groups: 1) Music therapy (MT), 2) Active Control, 3) Standard of Care.
Participants will receive the assigned intervention within 48 hours of admission, and this will continue up to the day of discharge. If a participant remains hospitalized for more than 15 days, the assigned intervention will stop at Day 15.
The study groups are described below:
MT arm:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded study coordinator will assess the primary outcome (Confusion Assessment Measure) to reduce bias.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted as inpatient to UMass Memorial Medical Center University Campus
- •Diagnosis of PD or DLB (ICD-10 G20 and G31.83 respectively) on active problem list or past medical history OR carbidopa/levodopa on active medication list or ordered in admission orders.
排除标准
- •Severe hearing loss (unable to perceive sound < 71dB)
- •Professed dislike or lack of reward with experiencing of all types of music (Barcelona Music Reward Questionnaire total score <40)
- •History of musicogenic seizures
- •Delirium present at initial assessment, as determined by a positive Confusion Assessment Method (CAM)
- •Admitted to observation status or to Clinical Decision Unit (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)
- •Patients who are currently prisoners will not be included
- •Patients admitted and discharged within 24 hours.
- •Patients in the intensive care unit receiving continuous intravenous sedative medication (as they would not be expected to be able to meaningfully participate in the study activities).
结局指标
主要结局
Confusion Assessment Measure (CAM)
时间窗: administered at enrollment and once every 24 hours during study period
A brief screening tool to assess for presence or absence of delirium
次要结局
- Medication Administration Records and Orders(From enrollment up to 30 days after enrollment.)
研究者
Kara Smith
Associate Professor
University of Massachusetts, Worcester