Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Delirium scores
研究概览
简要总结
In this pilot study a new kind of music therapy will be created and tested to help prevent confusion, called delirium, that can happen in the hospital. This can affect people with brain diseases like Alzheimer's disease and Parkinson's disease.
Each of the anticipated 30 participants will have up to five music therapy sessions. The sessions will be made just for them and may include live music, playing instruments, or listening to recorded music. Surveys will be used to learn how easy the therapy is to do in the hospital and what people think about how helpful the sessions may be for future patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 Boston Medical Center.
- •Cognitive impairment or neurodegenerative diseases as defined by either:
- •Diagnosis of Parkinson's Disease, Dementia with Lewy Bodies (ICD-10 G20 and G31.83 respectively), Alzheimer's Disease-related dementias (ICD-10 6D80), vascular dementia (F01), or other cognitive impairment (R41) on active problem list or past medical history
- •"Cognitive impairment" on active problem list or past medical history
- •Documentation elsewhere in the electronic medical record (e.g. notes) of any of these conditions
- •Participants with cognitive impairment will be included. If unable to consent, legally authorized representative (LAR) based on HRP-013-SOP-LARs, Children, and Guardians will be contacted to consent.
- •Spanish speaking participants will be included. Screening and informed consent procedures will be conducted using a certified medical interpreter. All intervention sessions and study team interactions will be conducted using these interpreter services.
- •Patients admitted to an intensive care unit will be included as long as they are not receiving continuous intravenous sedative medications. Potential participants in the intensive care unit setting will be discussed with a PI/co-I to ensure participation is appropriate on a case-by-case basis. The PI/Co-I will confirm with the treating physician that there are no reasons as to why the potential participant should not be enrolled in the study.
排除标准
- •Admitted to observation status (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)
- •Patients who will be discharged within 24 hours of eligibility based on discussion with primary admitting team
- •Self-reported history of musicogenic seizures
- •Hearing loss: unable to hear a recorded sound <70 decibels (dB)
- •Dislike of music: Barcelona Music Reward Questionnaire score of <40
- •Patients who are currently prisoners
- •Patients in the intensive care unit receiving continuous intravenous sedative medication
- •Pregnant women
研究组 & 干预措施
Music therapy
Participants will undergo one-on-one music therapy (MT) sessions of approximately 30 minutes duration conducted by a board-certified music therapist. Sessions will be customized to address patient needs but will consistently adhere to the four principal MT methods of re-creation, composition, improvisation, and therapeutic listening experiences.
干预措施: Music therapy (Behavioral)
结局指标
主要结局
Delirium scores
时间窗: every 24 hours until discharge (on average 7 days)
The 3-Minute Diagnostic Interview for the Confusion Assessment Method (3D-CAM) will be used to assess presence and severity of delirium. For participants who cannot complete the 3D-CAM due to non-verbal status, the CAM-ICU will be used in its place.
Number of music therapy sessions successfully completed
时间窗: during hospitalization, on average 7 days
次要结局
- Number of days that participants screen CAM-positive(during hospitalization, on average 7 days)
- Number of participants given antipsychotic medications(during hospitalization, on average 7 days)
- Number of participants requiring physical restraints(during hospitalization, on average 7 days)
- Number of participants with one-to-one sitter orders(during hospitalization, on average 7 days)