A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly-ELAMUS: study protocol.
Acupuncture
Elderly people
Multimodal approach
Music therapy
Sleep disorders
Traditional Chinese Medicine
Journal
BMC complementary medicine and therapies
ISSN: 2662-7671
Titre abrégé: BMC Complement Med Ther
Pays: England
ID NLM: 101761232
Informations de publication
Date de publication:
02 Aug 2024
02 Aug 2024
Historique:
received:
09
03
2024
accepted:
03
07
2024
medline:
3
8
2024
pubmed:
3
8
2024
entrez:
2
8
2024
Statut:
epublish
Résumé
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. 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. 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. German Clinical Trials Register (DRKS00031886).
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
German Clinical Trials Register (DRKS00031886).
Identifiants
pubmed: 39095748
doi: 10.1186/s12906-024-04581-4
pii: 10.1186/s12906-024-04581-4
doi:
Types de publication
Journal Article
Clinical Trial Protocol
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
295Informations de copyright
© 2024. The Author(s).
Références
Organization WH. Progress report on the United Nations Decade of Healthy Ageing. 2021-2023. Geneva: World Health Organization; 2023.
Basler HD, Hesselbarth S, Kaluza G, Schuler M, Sohn W, Nikolaus T. Komorbidität, Multimedikation und Befinden bei älteren Patienten mit chronischen Schmerzen. Der Schmerz. 2003;17(4):252–60.
pubmed: 12923674
doi: 10.1007/s00482-003-0231-0
Salive ME. Multimorbidity in older adults. Epidemiol Rev. 2013;35:75–83.
pubmed: 23372025
doi: 10.1093/epirev/mxs009
Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, et al. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011;10(4):430–9.
pubmed: 21402176
doi: 10.1016/j.arr.2011.03.003
Seger W, Gaertner T. Multimorbidität: Eine besondere Herausforderung. Deutsches Ärzteblatt. 2020;117(44):2092–6.
Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012;380(9836):37–43.
pubmed: 22579043
doi: 10.1016/S0140-6736(12)60240-2
van den Akker M, Buntinx F, Roos S, Knottnerus JA. Problems in determining occurrence rates of multimorbidity. J Clin Epidemiol. 2001;54(7):675–9.
pubmed: 11438407
doi: 10.1016/S0895-4356(00)00358-9
Beyer M, Otterbach I, Erler A, Muth C, Gensichen J, Gerlach FM. Multimorbidität in der Allgemeinpraxis Teil I: Pragmatische Definition. Epidemiologie und Versorgungsprämissen Z Allg Med. 2007;83:310–5.
doi: 10.1055/s-2007-985383
Steinhagen-Thiessen E, Borchelt M. Morbidität, Medikation und Funktionalität im Alter. In: Mayer KUBP, editor. Die Berliner Altersstudie. Berlin: Akademie Berlin; 1996. p. 151–83.
Schmitz MT, Just JM, Weckbecker K, Schmid M, Munster E. Multimorbidity and its importance in future health care in Germany: a secondary data analysis based on 67 million health insurance policy holders. Gesundheitswesen. 2023;85(10):871–7.
pubmed: 37253368
pmcid: 11248392
Panagioti M, Stokes J, Esmail A, Coventry P, Cheraghi-Sohi S, Alam R, et al. Multimorbidity and patient safety incidents in primary care: a systematic review and meta-analysis. PLoS ONE. 2015;10(8):e0135947.
pubmed: 26317435
pmcid: 4552710
doi: 10.1371/journal.pone.0135947
Doos L, Roberts EO, Corp N, Kadam UT. Multi-drug therapy in chronic condition multimorbidity: a systematic review. Fam Pract. 2014;31(6):654–63.
pubmed: 25192902
pmcid: 5942538
doi: 10.1093/fampra/cmu056
Moßhammer D, Haumann H, Mörike K, Joos S. Polypharmacy—an upward trend with unpredictable effects. Dtsch Arztebl Int. 2016;113(38):627.
pubmed: 27743469
pmcid: 5078862
Thürmann PA, Holt S, Nink K, Zawinell A. Arzneimittelversorgung älterer Patienten. In: Günster C, Klose J, Schmacke N, editors. Versorgungs-Report 2012. Stuttgart: Schattauer-Verlag; 2012. p. 111–30.
Bevölkerungsforschung Bf. Demografieportal des Bundes un Länder. 2017. Available from: http://www.demografie-portal.de/SharedDocs/Informieren/DE/ZahlenFakten/Bevoelkerung_Altersstruktur.html .
Leitliniengruppe Hessen D, ÄZQ, PVC, DEGAM. Hausärztliche Leitlinie Multimedikation - Empfehlungen zum Umgang mit Multimedikation bei Erwachsenen und geriatri-schen Paienten (053-043)(S3) 2021. Available from: https://www.degam.de/files/Inhalte/Leitlinien-Inhalte/Dokumente/DEGAM-S3-Leitlinien/053-043_Multimedikation/053-043l_Multimedikation_31-07-21.pdf .
Maher RL, Hanlon JT, Hajjar ER. Clinical consequences of polypharmacy in elderly. Expert opinion on drug safety. 2014;13(1). https://doi.org/10.1517/14740338.2013.827660 .
Kojima T, Akishita M, Nakamura T, Nomura K, Ogawa S, Iijima K, et al. Polypharmacy as a risk for fall occurrence in geriatric outpatients. Geriatr Gerontol Int. 2012;12(3):425–30.
pubmed: 22212467
doi: 10.1111/j.1447-0594.2011.00783.x
Bruder JLC, Schramm A, Tews HP, Werner H. Deutsche Gesellschaft für Geriatrie e.V. (DGG), Deutsche Gesellschaft für Gerontologie und Geriatrie e.V. (DGGG) - Was ist Geriatrie? Definition des Faches Geriatrie. 2005.
Happe S. Schlaf und seine Störungen im Alter. Somnologie. 2012;16(2):80–7.
doi: 10.1007/s11818-012-0564-y
AWMF D. Anwenderversion zur S3 Leitlinie “Nicht erholsamer Schlaf/Schlafstörungen” 2017 [Available from: https://www.degam.de/files/Inhalte/Leitlinien-Inhalte/Dokumente/Interdisziplinaere%20Leitlinien/063-003_Insomnie/063-003_DEGAM%20Anwenderversion_17-06-2017.pdf .
Schwartz S, McDowell Anderson W, Cole SR, Cornoni-Huntley J, Hays JC, Blazer D. Insomnia and heart disease: a review of epidemiologic studies. J Psychosom Res. 1999;47(4):313–33.
pubmed: 10616226
doi: 10.1016/S0022-3999(99)00029-X
Kripke DF, Garfinkel L, Wingard DL, Klauber MR, Marler MR. Mortality associated with sleep duration and insomnia. Arch Gen Psychiatry. 2002;59(2):131–6.
pubmed: 11825133
doi: 10.1001/archpsyc.59.2.131
Baglioni C, Battagliese G, Feige B, Spiegelhalder K, Nissen C, Voderholzer U, et al. Insomnia as a predictor of depression: A meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord. 2011;135(1):10–9.
pubmed: 21300408
doi: 10.1016/j.jad.2011.01.011
Riemann D, Baum E, Cohrs S, Crönlein T, Hajak G, Hertenstein E, et al. S3-Leitlinie Nicht erholsamer Schlaf/Schlafstörungen. Somnologie. 2017;21(1):2–44.
doi: 10.1007/s11818-016-0097-x
Bergert FW, Braun M, Ehrenthal K, Fessler J, Gross J, Huttner U, et al. Recommendations for treating adult and geriatric patients on multimedication. Int J Clin Pharmacol Ther. 2014;52(Suppl 1):1–64.
pubmed: 25310921
doi: 10.5414/CPP52S001
Yeung WF, Chung KF, Zhang ZJ, Chan WC, Zhang SP, Ng RMK, et al. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial. BMC Complement Alternat Med. 2017;17(1):183.
doi: 10.1186/s12906-017-1692-5
Konfuzius, (Übersetzer) Wilhelm R. Yueji - Buch der Musik. In: Verlag m, editor. Das Buch der Riten, Sitten und Gebräuche. 1 (20. Sept. 2014) ed1930.
Wei LB, Wilhelm R. Chunqiu – Frühling und Herbst des Lü Bu We: Anaconda. 2009.
Valentini J. Can traditional Chinese medicine help cancer patients? Rev Med Suisse. 2016;12(503):213–5.
pubmed: 26939187
Kemper KJ, Danhauer SC. Music as therapy. South Med J. 2005;98(3):282–8.
pubmed: 15813154
doi: 10.1097/01.SMJ.0000154773.11986.39
Dosch J, Timmermann T. Das Buch vom Monochord: Hören – Spielen – Messen – Bauen: Reichert. 2005. p. 192.
Gabel C, Garrido N, Koenig J, Hillecke TK, Warth M. Effects of monochord music on heart rate variability and self-reports of relaxation in healthy adults. Complement Med Res. 2017;24(2):97–103.
pubmed: 28192781
doi: 10.1159/000455133
Sandler H, Fendel U, Busse P, Rose M, Bosel R, Klapp BF. Relaxation - induced by vibroacoustic stimulation via a body monochord and via relaxation music - is associated with a decrease in tonic electrodermal activity and an increase of the salivary cortisol level in patients with psychosomatic disorders. PLoS ONE. 2017;12(1):e0170411.
pubmed: 28114399
pmcid: 5256965
doi: 10.1371/journal.pone.0170411
Warth M, Kessler J, Hillecke TK, Bardenheuer HJ. Music
pubmed: 26806566
pmcid: 4671329
Wilhelm R, Ging I. Das Buch der Wandlungen: Anaconda. 2011;31.
Musikwelt A. I Ging Monochord. 2017. Available from: http://www.anklang-musikwelt.de/d/instrumente/monochorde/igingmonochord.html .
Cheuk DK, Yeung WF, Chung KF, Wong V. Acupuncture for insomnia. Cochrane Database Syst Rev. 2012(9):CD005472.
Lan Y, Wu X, Tan HJ, Wu N, Xing JJ, Wu FS, et al. Auricular acupuncture with seed or pellet attachments for primary insomnia: a systematic review and meta-analysis. BMC Complement Altern Med. 2015;15:103.
pubmed: 25886561
pmcid: 4425871
doi: 10.1186/s12906-015-0606-7
Yeung WF, Chung KF, Poon MM, Ho FY, Zhang SP, Zhang ZJ, et al. Acupressure, reflexology, and auricular acupressure for insomnia: a systematic review of randomized controlled trials. Sleep Med. 2012;13(8):971–84.
pubmed: 22841034
doi: 10.1016/j.sleep.2012.06.003
de Niet G, Tiemens B, Lendemeijer B, Hutschemaekers G. Music-assisted relaxation to improve sleep quality: meta-analysis. J Adv Nurs. 2009;65(7):1356–64.
pubmed: 19456998
doi: 10.1111/j.1365-2648.2009.04982.x
Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015;2015(8):CD010459.
pubmed: 26270746
pmcid: 9241357
Wang CF, Sun YL, Zang HX. Music therapy improves sleep quality in acute and chronic sleep disorders: a meta-analysis of 10 randomized studies. Int J Nurs Stud. 2014;51(1):51–62.
pubmed: 23582682
doi: 10.1016/j.ijnurstu.2013.03.008
Pitkala KH, Strandberg TE. Clinical trials in older people. Age Ageing. 2022;51(5):afab282.
pubmed: 35526845
pmcid: 9080968
doi: 10.1093/ageing/afab282
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
pubmed: 23295957
pmcid: 5114123
doi: 10.7326/0003-4819-158-3-201302050-00583
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
pubmed: 23303884
pmcid: 3541470
doi: 10.1136/bmj.e7586
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213.
pubmed: 2748771
doi: 10.1016/0165-1781(89)90047-4
Cao H, Pan X, Li H, Liu J. Acupuncture for treatment of insomnia: a systematic review of randomized controlled trials. J Altern Complement Med. 2009;15(11):1171–86.
pubmed: 19922248
pmcid: 3156618
doi: 10.1089/acm.2009.0041
Huang W, Kutner N, Bliwise DL. A systematic review of the effects of acupuncture in treating insomnia. Sleep Med Rev. 2009;13(1):73–104.
pubmed: 19097814
doi: 10.1016/j.smrv.2008.04.002
MacPherson HAD, Hammerschlag R, Youping L, Taixiang W, White A, Moher D. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med. 2010;28(2):83–93.
pubmed: 20615861
pmcid: 3002761
doi: 10.1136/aim.2009.001370
Deadman P A-KM, Baker K. A manual of acupuncture: Eastland Press; 2001.
Buysse DJ, Hall ML, Strollo PJ, Kamarck TW, Owens J, Lee L, et al. Relationships between the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and clinical/polysomnographic measures in a community sample. J Clin Sleep Med. 2008;4(6):563–71.
pubmed: 19110886
pmcid: 2603534
doi: 10.5664/jcsm.27351
Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991;14(4):331–8.
pubmed: 1947597
Smyth CA. Evaluating sleep quality in older adults: the Pittsburgh Sleep Quality Index can be used to detect sleep disturbances or deficits. Am J Nurs. 2008;108(5):42–50; quiz -1.
pubmed: 18434798
doi: 10.1097/01.NAJ.0000317300.33599.63
Allgaier AK, Kramer D, Mergl R, Fejtkova S, Hegerl U. Validity of the geriatric depression scale in nursing home residents: comparison of GDS-15, GDS-8, and GDS-4. Psychiatr Prax. 2011;38(6):280–6.
pubmed: 21598210
doi: 10.1055/s-0030-1266105
Drixler K, Morfeld M, Glaesmer H, Brahler E, Wirtz MA. [Validation of the Short-Form-Health-Survey-12 (SF-12 Version 2.0) assessing health-related quality of life in a normative German sample]. Z Psychosom Med Psychother. 2020;66(3):272–86.
pubmed: 32876561
Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: a systematic review of empirical tests. Soc Sci Med. 2022;292:114523.
pubmed: 34785096
doi: 10.1016/j.socscimed.2021.114523
Rux M. Erprobung der deutschen Übersetzung des Phenomenology of Consciousness Inventory von Pekala: Normwerte. Änderungsvorschläge: Gütekriterien; 2002.
Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42(5):533–44.
pubmed: 24193818
pmcid: 4012002
doi: 10.1007/s10488-013-0528-y
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95: 103208.
pubmed: 31078660
pmcid: 7254481
doi: 10.1016/j.jbi.2019.103208
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.
pubmed: 18929686
doi: 10.1016/j.jbi.2008.08.010
Correia ATL, Lipinska G, Rauch HGL, Forshaw PE, Roden LC, Rae DE. Associations between sleep-related heart rate variability and both sleep and symptoms of depression and anxiety: A systematic review. Sleep Med. 2023;101:106–17.
pubmed: 36370515
doi: 10.1016/j.sleep.2022.10.018
Kuckartz U. Qualitative inhaltsanalyse. Methoden, Praxis. Computerunterstützung. Weinheim, Basel: Beltz Juventa; 2018.
Chae Y, Lee YS, Enck P. How placebo needles differ from placebo pills? Front Psychiatry. 2018;9:243.
pubmed: 29930521
pmcid: 6000751
doi: 10.3389/fpsyt.2018.00243
Appleyard I, Lundeberg T, Robinson N. Should systematic reviews assess the risk of bias from sham–placebo acupuncture control procedures? European J Integ Med. 2014;6(2):234–43.
doi: 10.1016/j.eujim.2014.03.004
Xiang Y, He JY, Li R. Appropriateness of sham or placebo acupuncture for randomized controlled trials of acupuncture for nonspecific low back pain: a systematic review and meta-analysis. J Pain Res. 2018;11:83–94.
pubmed: 29343984
doi: 10.2147/JPR.S152743
Wood R, Lewith G. The credibility of placebo controls in acupuncture studies. Complement Ther Med. 1998;6(2):79–82.
doi: 10.1016/S0965-2299(98)80080-0
National center for complementary and integrative health N. Acupuncture - priorities 2019. Available from: https://nccih.nih.gov/grants/acupuncture/priorities .