PDF(Pubmed)
Abstract：
BACKGROUND: Dementia is often associated with Neuropsychiatric Symptoms (NPS) such as agitation, depression, hallucinations, anxiety, that can cause distress for the resident with dementia in long-term care settings and can impose emotional burden on the environment. NPS are often treated with psychotropic drugs, which, however, frequently cause side effects. Alternatively, non-pharmacological interventions can improve well-being and maintain an optimal quality of life (QoL) of those living with dementia. Other QoL related outcomes, such as pain, discomfort and sleep disruption are relevant outcomes in music trials as well. Music therapy is a non-pharmacological intervention that can reduce NPS and improve well-being, and its associated symptoms in dementia.
METHODS: The research will be conducted at eight nursing home facilities of a health care organization in the Netherlands. A sample size of 30 in each group (experimental and control group) is required, totalling 60 residents increased to 80 when considering expected drop out to follow up. The participants in the intervention group receive 30 min of individual music therapy (MT) in their own room by a music therapist twice a week for 12 weeks. The participants in the control group will receive 30 min of individual attention in their own room by a volunteer twice a week for 12 weeks. Assessments will be done at baseline, 6 weeks and 12 weeks. An independent observer, blinded for the intervention or control condition, will assess directly observed well-being (primary outcome) and pain (secondary outcome) before and after the sessions. Nurses will assess other secondary outcomes unblinded, i.e., perceived quality of life and NPS, both assessed with validated scales. The sleep duration will be indirectly assessed by a wrist device called MotionWatch. Information about psychotropic drug use will be derived from electronic medical chart review.
CONCLUSIONS: The main purpose of this study is to assess the effects of individual music therapy on directly observed well-being controlled for individual attention in nursing home residents with dementia with NPS. The outcomes refer to both short-term and long-term effects consistent with therapeutic goals of care for a longer term. We hope to overcome limitations of previous study designs such as not blinded designs and music facilitators that were not only music therapists but also occupational therapists and nurses. This study should lead to more focused recommendations for practice and further research into non-pharmacological interventions in dementia such as music therapy.
BACKGROUND: The trial is registered at the International Clinical Trials Registry Platform (ICTRP) search portal in the Netherlands Trial Registration number NL7708, registration date 04-05-2019.
METHODS: The research will be conducted at eight nursing home facilities of a health care organization in the Netherlands. A sample size of 30 in each group (experimental and control group) is required, totalling 60 residents increased to 80 when considering expected drop out to follow up. The participants in the intervention group receive 30 min of individual music therapy (MT) in their own room by a music therapist twice a week for 12 weeks. The participants in the control group will receive 30 min of individual attention in their own room by a volunteer twice a week for 12 weeks. Assessments will be done at baseline, 6 weeks and 12 weeks. An independent observer, blinded for the intervention or control condition, will assess directly observed well-being (primary outcome) and pain (secondary outcome) before and after the sessions. Nurses will assess other secondary outcomes unblinded, i.e., perceived quality of life and NPS, both assessed with validated scales. The sleep duration will be indirectly assessed by a wrist device called MotionWatch. Information about psychotropic drug use will be derived from electronic medical chart review.
CONCLUSIONS: The main purpose of this study is to assess the effects of individual music therapy on directly observed well-being controlled for individual attention in nursing home residents with dementia with NPS. The outcomes refer to both short-term and long-term effects consistent with therapeutic goals of care for a longer term. We hope to overcome limitations of previous study designs such as not blinded designs and music facilitators that were not only music therapists but also occupational therapists and nurses. This study should lead to more focused recommendations for practice and further research into non-pharmacological interventions in dementia such as music therapy.
BACKGROUND: The trial is registered at the International Clinical Trials Registry Platform (ICTRP) search portal in the Netherlands Trial Registration number NL7708, registration date 04-05-2019.
摘要：
背景：痴呆症通常与神经精神症状（NPS）有关，例如躁动，抑郁症,幻觉,焦虑,这可能会给长期护理环境中患有痴呆症的居民带来痛苦，并可能给环境带来情感负担。NPS通常用精神药物治疗，which,然而,经常引起副作用。或者，非药物干预可以改善痴呆症患者的健康并维持最佳生活质量(QoL).其他QoL相关结果，如疼痛，不适和睡眠中断也是音乐试验的相关结果.音乐疗法是一种非药物干预措施，可以减少NPS并改善幸福感，及其在痴呆症中的相关症状。
方法：这项研究将在荷兰一家医疗机构的八个疗养院进行。每组（实验组和对照组）的样本量为30，考虑到预期的辍学跟进，共有60名居民增加到80名。干预组的参与者在自己的房间里接受音乐治疗师30分钟的个人音乐疗法（MT），每周两次，持续12周。对照组的参与者将在自己的房间中接受志愿者的30分钟的个人关注，每周两次，持续12周。评估将在基线进行，6周和12周。一个独立的观察者,对干预或控制条件视而不见，将在会议之前和之后直接评估观察到的健康（主要结果）和疼痛（次要结果）。护士将评估其他次要结果，即，感知的生活质量和NPS，两者都用经过验证的量表进行评估。睡眠持续时间将由称为MotionWatch的手腕设备间接评估。有关精神药物使用的信息将来自电子医学图表审查。
结论：这项研究的主要目的是评估个人音乐疗法对NPS痴呆的养老院居民中直接观察到的健康控制的影响。结果是指短期和长期效果与长期护理目标一致。我们希望克服以前研究设计的局限性，例如不盲目的设计和音乐促进者，不仅是音乐治疗师，而且是职业治疗师和护士。这项研究应该为实践提供更有针对性的建议，并进一步研究痴呆症的非药物干预措施，如音乐疗法。
背景：该试验已在荷兰的国际临床试验注册平台（ICTRP）搜索门户注册试验注册号NL7708，注册日期04-05-2019。
方法：这项研究将在荷兰一家医疗机构的八个疗养院进行。每组（实验组和对照组）的样本量为30，考虑到预期的辍学跟进，共有60名居民增加到80名。干预组的参与者在自己的房间里接受音乐治疗师30分钟的个人音乐疗法（MT），每周两次，持续12周。对照组的参与者将在自己的房间中接受志愿者的30分钟的个人关注，每周两次，持续12周。评估将在基线进行，6周和12周。一个独立的观察者,对干预或控制条件视而不见，将在会议之前和之后直接评估观察到的健康（主要结果）和疼痛（次要结果）。护士将评估其他次要结果，即，感知的生活质量和NPS，两者都用经过验证的量表进行评估。睡眠持续时间将由称为MotionWatch的手腕设备间接评估。有关精神药物使用的信息将来自电子医学图表审查。
结论：这项研究的主要目的是评估个人音乐疗法对NPS痴呆的养老院居民中直接观察到的健康控制的影响。结果是指短期和长期效果与长期护理目标一致。我们希望克服以前研究设计的局限性，例如不盲目的设计和音乐促进者，不仅是音乐治疗师，而且是职业治疗师和护士。这项研究应该为实践提供更有针对性的建议，并进一步研究痴呆症的非药物干预措施，如音乐疗法。
背景：该试验已在荷兰的国际临床试验注册平台（ICTRP）搜索门户注册试验注册号NL7708，注册日期04-05-2019。
