C Klocke, K Rhein, H Cramer, B Kröger, A-J Wetzel, J Vagedes, H Mauch, F Beißner, S Joos, J Valentini
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The purpose of this study is to evaluate the effectiveness of acupuncture and music therapy, both individually and combined as a multimodal therapy, in the treatment of sleep disorders in individuals aged 70 years and older.</p><p><strong>Methods: </strong>We conduct a confirmatory randomized controlled trial using a two-factorial study design. A total of n = 100 elderly people receive evidence-based standard care information for age-related sleep disorders. Beyond that, patients are randomly assigned into four groups of n = 25 each to receive acupuncture, receptive music therapy with a monochord, multimodal therapy with both acupuncture and music therapy, or no further therapy. The study's primary outcome measurement is the improvement in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (global score), at the end of intervention. 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引用次数: 0
摘要
背景:在全球范围内,人口向老龄化的转变给医疗保健系统带来了巨大的挑战,特别是由于多病症的发病率不断上升,导致老年人使用多种药物。同时,睡眠障碍也是老年人的常见病。使用药物治疗往往会产生副作用,造成很大的依赖性。在这种情况下,亟需探索非药物治疗方法。本研究的目的是评估针灸和音乐疗法作为一种多模式疗法单独或联合治疗 70 岁及以上老年人睡眠障碍的效果:我们采用双因素研究设计进行了一项确证性随机对照试验。共有 n = 100 名老年人接受以循证医学为基础的标准护理信息,以治疗与年龄相关的睡眠障碍。除此之外,患者会被随机分配到四组,每组 n = 25 人,分别接受针灸、单弦接受性音乐疗法、针灸和音乐疗法的多模式疗法,或不再接受其他疗法。研究的主要结果是在干预结束时,通过匹兹堡睡眠质量指数(PSQI)(总分)评估睡眠质量的改善情况。此外,还收集了抑郁评分(老年抑郁量表)、健康相关生活质量(短表格健康调查-12)、通过心率变异性测量的神经活力活动以及安全性数据,作为次要结果。将采用混合方法进行定性过程评估,以补充定量数据:该研究正在进行中,最后一名患者预计将于 2024 年 4 月入组。研究结果将为老年人睡眠障碍的非药物干预措施的有效性提供有价值的见解,有助于在老年医疗保健中采用更加个性化和全面的方法:德国临床试验注册(DRKS00031886)。
A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly-ELAMUS: study protocol.
Background: Globally, the demographic shift towards an aging population leads to significant challenges in healthcare systems, specifically due to an increasing incidence of multimorbidity resulting in polypharmacy among the elderly. Simultaneously, sleep disorders are a common complaint for elderly people. A treatment with pharmacological therapies often leads to side effects causing a high potential for dependency. Within this context, there is a high need to explore non-pharmacological therapeutic approaches. The purpose of this study is to evaluate the effectiveness of acupuncture and music therapy, both individually and combined as a multimodal therapy, in the treatment of sleep disorders in individuals aged 70 years and older.
Methods: We conduct a confirmatory randomized controlled trial using a two-factorial study design. A total of n = 100 elderly people receive evidence-based standard care information for age-related sleep disorders. Beyond that, patients are randomly assigned into four groups of n = 25 each to receive acupuncture, receptive music therapy with a monochord, multimodal therapy with both acupuncture and music therapy, or no further therapy. The study's primary outcome measurement is the improvement in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (global score), at the end of intervention. Additionally, depression scores (Geriatric Depression Scale), health-related quality of life (Short-Form-Health Survey-12), neurovegetative activity measured via heart rate variability, and safety data are collected as secondary outcomes. Using a mixed-methods approach, a qualitative process evaluation will be conducted to complement the quantitative data.
Discussion: The study is ongoing and the last patient in is expected to be enrolled in April 2024. The results can provide valuable insights into the effectiveness of non-pharmacological interventions for sleep disorders among the elderly, contributing to a more personalized and holistic approach in geriatric healthcare.
Trial registration: German Clinical Trials Register (DRKS00031886).