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BMC Complementary Medicine and Therapies
Article . 2024 . Peer-reviewed
License: CC BY
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A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly—ELAMUS: study protocol

Authors: Klocke, C.; Rhein, K.; Cramer, H.; Kröger, B.; Wetzel, A-J.; Vagedes, J.; Mauch, H.; +3 Authors

A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly—ELAMUS: study protocol

Abstract

Abstract 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).

Related Organizations
Keywords

Aged, 80 and over, Male, Sleep Wake Disorders, Acupuncture Therapy, Acupuncture, Sleep disorders, Elderly people, Female [MeSH] ; Aged, 80 and over [MeSH] ; Music therapy ; Aged [MeSH] ; Study Protocol ; Humans [MeSH] ; Acupuncture ; Sleep Wake Disorders/therapy [MeSH] ; Elderly people ; Sleep disorders ; Randomized Controlled Trials as Topic [MeSH] ; Male [MeSH] ; Traditional Chinese Medicine ; Acupuncture Therapy/methods [MeSH] ; Multimodal approach ; Music Therapy [MeSH], Multimodal approach, Other systems of medicine, Study Protocol, Traditional Chinese Medicine, Humans, Female, Music therapy, Music Therapy, RZ201-999, Aged, Randomized Controlled Trials as Topic

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
1
Average
Average
Average
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