Department of primary and long-term care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Faculty of Behavioral and Movement Sciences, Clinical Neuropsychology, Amsterdam, The Netherlands.
BMC Geriatr. 2024 Mar 27;24(1):290. doi: 10.1186/s12877-024-04863-z.
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.
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.
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.
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.
痴呆症常伴有神经精神症状（NPS），如激越、抑郁、幻觉、焦虑等，这些症状会给长期护理环境中的痴呆症患者带来痛苦，并给环境带来情感负担。NPS 常采用精神药物治疗，但这些药物常引起副作用。而非药物干预措施可以改善痴呆症患者的幸福感，维持其最佳生活质量（QoL）。其他与 QoL 相关的结果，如疼痛、不适和睡眠中断，也是音乐试验中的相关结果。音乐疗法是一种非药物干预措施，可以减轻痴呆症患者的 NPS 并改善其幸福感及其相关症状。
该研究将在荷兰一家医疗保健组织的八家养老院进行。每组（实验组和对照组）需要 30 名样本量，增加到 80 名，考虑到预期的随访脱落。实验组的参与者每周两次在自己的房间里接受由音乐治疗师进行 30 分钟的个体音乐治疗（MT），为期 12 周。对照组的参与者每周两次在自己的房间里接受志愿者的 30 分钟个体关注，为期 12 周。评估将在基线、6 周和 12 周进行。一名独立观察员将对干预或对照条件进行盲法评估，在治疗前后直接观察评估幸福感（主要结局）和疼痛（次要结局）。护士将对其他次要结局进行非盲评估，即使用经过验证的量表评估感知生活质量和 NPS。通过称为 MotionWatch 的腕部设备间接评估睡眠时间。精神药物使用信息将从电子病历审查中获得。
本研究的主要目的是评估个体音乐疗法对伴有 NPS 的痴呆症养老院居民直接观察到的幸福感的影响，同时控制个体注意力。这些结果既涉及短期影响，也涉及长期影响，符合长期护理的治疗目标。我们希望克服以前研究设计的局限性，例如非盲设计和音乐治疗师不仅是音乐治疗师，还是职业治疗师和护士的音乐治疗师。本研究应能为痴呆症的非药物干预措施（如音乐疗法）提供更有针对性的实践建议和进一步研究。
该试验在荷兰临床试验注册平台（ICTRP）搜索门户中注册，注册号为 NL7708，注册日期为 2019 年 5 月 4 日。
