Evidence map›Paper›PMID 39095748›Full record

ArticleBMC complementary medicine and therapies2024

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

C Klocke, K Rhein, H Cramer, B Kröger, A-J Wetzel, J Vagedes, H Mauch, F Beißner, S Joos, J Valentini

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

C KlockeInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany. carina.klocke@med.uni-tuebingen.de.
K RheinInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany.
H CramerInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany.
B KrögerInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany.
A-J WetzelInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany.
J VagedesARCIM Institute, Filderklinik, Filderstadt, Germany.
H MauchInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany.
F BeißnerInsula Institute for Integrative Therapy Research, Hannover, Germany.
S JoosInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany.
J ValentiniInstitute of General Practice and Interprofessional Care, University Hospital and Faculty of Medicine Tübingen, Tübingen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlobally, 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.

methodsWe 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 registrationGerman Clinical Trials Register (DRKS00031886).

Indexed as

Acupuncture TherapyMusic TherapySleep Wake DisordersAgedAged, 80 and overFemaleHumansMaleRandomized Controlled Trials as TopicAcupunctureElderly peopleMultimodal approachMusic therapySleep disordersTraditional Chinese Medicine

Identifiers

PMID39095748
PMCPMC11295593

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.