EffectofNordicSensi® ChaironBehavioral andPsychologicalSymptomsofDementia inNursingHomesResidents:
ARandomizedControlledTrial
Jos ´ eMar´ıaGarc´ıa-Albercaa ,∗ ,Mar´ıaDoloresdelaRosaa ,PalomaSolodeZald´ıvara , Mar´ıaLedesmaa ,EstelaOltraa ,EstherGrisa ,OlgaOcejob ,JavierTorrecillab ,CarmenZafrab , AnaS ´ anchez-Fern ´ andezc ,Tom ´ asMancillac ,MercedesL ´ opez-Romeroc ,RaquelJereza , NuriaSantanaa ,Jos ´ ePabloLarad ,Miguel ´ AngelBarbanchod andEncarnaci ´ onBlanco-Reinae
a AlzheimerResearchCenterandMemoryClinic,InstitutoAndaluzdeNeurociencia(IANEC),M´alaga,Spain
b CentroResidencialAlmudena,Rinc´ondelaVictoria,Spain
c ResidenciaDomusViFuentesol,Alhaur´ındelaTorre,Spain
d BrainHealthUnit,SchoolofMedicine,UniversityofM´alaga,M´alaga,Spain
e PharmacologyandTherapeuticsDepartment,SchoolofMedicine,UniversityofM´alaga,M´alaga,Spain
Accepted29September2023
Pre-press21November2023
Abstract
Background: Behavioralandpsychologicalsymptomsofdementia(BPSD)arepresentinmostpeoplewithdementia(PwD), includingAlzheimer’sdisease.Thereisconsensusthatnon-pharmacologicaltherapiesrepresentthefirstlineoftreatmentto addressBPSD.
Objective: Weexploretheefficacyoftheuseofarockingchair(NordicSensi® Chair,NSC)inthetreatmentofBPSDin nursinghomeresidentswithmoderateandseveredementia.
Methods: Wecarriedouta16-weekrandomized,single-blind,controlled,clinicaltrialwithPwDadmittedtonursinghomes. Participantswereassignedtoatreatmentgroup(n =40)thatreceivedthreetimesaweekonesessionperdayof20minutes intheNSCandacontrolgroup(n =37).TheNeuropsychiatricInventory-NursingHome(NPI-NH)wasusedasprimary efficacyoutcome.OccupationaldistressforthestaffwasevaluatedusingtheNPI-NHOccupationalDisruptivenesssubscale (NPI-NH-OD).StatisticalanalyseswereconductedbymeansofaMixedEffectsModelAnalysis.
Results: TreatmentwiththeNSCwasassociatedwithabeneficialeffectinmostofBPSD,asreflectedbydifferencesbetween thetreatmentandcontrolgroupontheNPI-NHtotalscore(meanchangescore–18.87 ± 5.56versus–1.74 ± 0.67, p =0.004), agitation(meanchangescore–2.32 ± 2.02versus–0.78 ± 1.44, p =0.003)andirritability(meanchangescore–3.35 ± 2.93 versus–1.42 ± 1.31, p =0.004).TheNPI-NH-ODtotalscorealsoimprovedthemostinthetreatmentgroup(meanchange score–9.67 ± 7.67versus–7.66 ± 6.08, p =0.003).
Conclusions: ThereductioninoverallBPSDalongwithdecreasedcaregiveroccupationaldisruptivenessrepresentencouragingfindings,addingtothepotentialofnonpharmacologicalinterventionsfornursinghomeresidentslivingwithdementia.
∗ Correspondenceto:JoseMarıaGarcıa-Alberca,Alzheimer ResearchCenterandMemoryClinic,InstitutoAndaluzdeNeurociencia(IANEC),C/ ´ Alamos,17,29102M ´ alaga,Spain.Tel.:
+34952212022;E-mail:jmgalberca@ianec.com;ORCID:00000003-2951-6644
ISSN1387-2877©2023–Theauthors.PublishedbyIOSPress.ThisisanOpenAccessarticledistributedundertheterms oftheCreativeCommonsAttribution-NonCommercialLicense(CCBY-NC4.0).
Trialregistration: ThisstudyisregisteredonClinicalTrials.govwiththeidentifierNCT05706792onJanuary31,2023.
Keywords:Alzheimer’sdisease,behavioralandpsychologicalsymptomsofdementia,dementia,non-pharmacologicalintervention,nursinghome
INTRODUCTION
Dementiaisasyndromecharacterizedbyaprogressiveimpairmentofthecognitiveandfunctional abilitieswithimportantimplicationsforindividuals andsociety.Thenumberofpeoplewithdementia (PwD)isexpectedtoincreaseto82millionby2030 andalmostdoubleby2050[1].
Inadditiontothecognitiveandfunctionaldeficits, behavioralandpsychologicalsymptomsofdementia(BPSD)areoneofthemostimportantchallenges thatbothPwDandtheircaregiversfacethroughout thecourseofthedisease[2].BPSDconsistofaheterogeneousgroupofsymptomssuchasdepression, delusions,hallucinations,irritability,disinhibition, agitation,apathy,orsleepandeatingproblems[3].
BPSDresultsindecreasedPwDwell-being,impaired qualityoflife,andcauseaheavyburdenoncaregivers,oftenleadingcaregiverstomakethedecision toinstitutionalize[4,5].Innursing-homesBPSDcan beamajorstressforboththecarestaffandtheresidentsthemselves[6].
BPSDmanagementincludesbothpharmacologicalandnon-pharmacologicaltherapies[7].
MedicationisoftenusedandmanyPwDaretreated withpsychotropicdrugs,althoughinmanycases achieveonlymodestbenefitsincontrollingsymptoms whileexposingpatientstotheriskofpossibleadverse events[8].Onthecontrary,non-pharmacological interventionsareconsideredtohavefewerundesirableeffectsmakingthemsaferoptions,withatleast thesameefficacyasmedication,inmostcases[9,10]. Infact,currentlythereisaconsensustoconsidernonpharmacologicaltherapiesasthefirstlinetreatment ofBPSDwiththeexceptionofemergencysituations [11].
Awiderangeofnon-pharmacologicalapproaches haveshownpositiveresultsforthemanagementof BPSDincludingphysicalexercise,musictherapy, multisensorystimulation,psycho-educationalinterventionsforcaregiversorcarestafftraining[12]. However,theneedforthedevelopmentandapplicationofnewnon-pharmacologicaltherapiesispresent [11,13].
Withinthiscontext,modernrockingchairsmay besuitableforlong-termcarebecauserocking,a
rhythmicallyrepeatedmovement,cancontributeto psychosocialwellbeing[14].However,onlyafew studieshaveevaluatedtheuseofrockingchairsfor PwD.A6-weekstudyinnursinghomesshowedthat theuseofarockingchairproducedimprovementsin anxietyanddepressionaswellasreductionsinpain medication[14].Theresultsofarepeated-measures studyrevealedthattheuseofaglidersignificantly improvedemotionsandrelaxationinpeoplewith severedementiaadmittedtonursinghomes[15].In thesameline,findingsfromastudyusingarocking chairshowedadecreaseinBPSDandanincreasein qualityoflifeinPWDinanursinghome[16].Ina multicentersurveyoflong-termcarefacilitiesstaff reportedtheuseofarockingchairimprovedquality ofcareandcontributedtoacalmerenvironmentfor PwD[17].
Inthisregard,itisofinteresttoconsiderthetherapeuticroleoftheNordicSensi® Chair(NSC)inthe treatmentofBPSDbasedonitsabilitytoofferPwDa sensoryexperiencethatbringsthebenefitsofmusic, therapeutictactilestimulation,vestibularstimulation, andrelaxationinanintegratedway,especiallythose innursinghomes.
Music-basedinterventionswereoriginallydevelopedwiththeaimofaccomplishingindividualized goalsandofferapromisingoptioniftargetedand evaluatedeffectively[18].TheuseofmusicinPwD isbasedontheancestrallinkbetweensoundsand thehumanbeinganditspotentialtoevokeemotionsexperiencedthroughouttheirlives.Musiccan becomeawayofexpressingtheiremotionsindaily life,thuspreventingtheonsetofanxiousoragitated behaviors[19,20].
IfPwDishyperaroused,tactilestimulationand vestibularstimulationisapowerfultooltohelpregulatearousallevelstoenableself-calmingandfocused attention,especiallywhenPwDisagitated[21].Linearmovementactivities(e.g.,forward–backrocking andswinging)coupledwithlow-frequencysounds arecalmingandservetoinhibitthereticularactivatingsystemviathevestibularsystem[21].
Themainobjectiveofthisstudywastoevaluate theeffectivenessoftheNSCinthemanagementof BPSDinrealclinicalpracticeinPwDadmittedto nursinghomes.Thesecondaryobjectivewastoassess
thebenefitsoftheNSConcognitivefunctioningand qualityoflifeofPwDaswellasitspotentialbenefits ontheoccupationaldisruptivenessofcarestaff.
METHODS
Participants
Studyparticipantshadadiagnosisofdementiaaccordingtothecriteriaofthe11th editionof theInternationalClassificationofDiseasesofthe WorldHealthOrganization[22]and/orprobable Alzheimer’sdisease(AD)accordingtothecriteriaof theNationalInstituteonAgingAlzheimer’sAssociationworkgroups(NIA/AA)[23].PwDwererecruited fromtwonursinghomesspecializedindementiacare: CentroResidencialAlmudena(Rinc ´ ondelaVictoria, M ´ alaga,Spain)andResidenciaDomusViFuentesol (Alhaur´ındelaTorre,M ´ alaga,Spain).Dementia severitywasassessedwiththeReisbergGlobalDeteriorationScale(GDS)[24]bytheclinicianincharge. PwDincludedinthestudywereclinicallydefinedin stages4to7oftheGDS.
CentroResidencialAlmudenahasacapacityfor50 usersandoffersspecializedservicesforAlzheimer’s andotherdementias.Thehealthcareteamismadeup ofinternistsandpsychologists,inadditiontomedicaladvisorsineachspecialty.DomusViFuentesol Residencehasatotalof146bedsandcenterhasan interdisciplinaryteamwhooffersspecializedservices fordementiaandneurocognitivedisorders.
ExclusioncriteriaincludedPwDwhohadanyevidenceoffocalvascularlesions(suchashematomas), stroke,normalpressurehydrocephalus;thosewith serioussystemicdiseasessuchashypothyroidismor chronicrenalfailure;thosewithachronicsensory disorder(e.g.,severevisionandhearingimpairment) orseverepsychiatricdisorder.
Consideringthevariabilityreportedintheliteratureoftheclinicalassessmentinstrumentsusedin thepresentstudy,itwasanticipatedthatasampleof 70PwD(35ineachofthetwogroups)wouldallow detection,with80%powerandananticipatedeffect sizeof0.5,fortheprimaryefficacyvariableNPI-NH totalscoreofastatisticallysignificantdifferencein themeanof2.5pointsormorebetweenthetwostudy groups,assumingastandarddeviationof1.5points [25].
Thestudyincludedtheevaluationofcarestafffrom bothnursinghomeswhoparticipatedinthedirectprovisionofcaretotheparticipatingPwD.Thedegree towhichthepresenceofBPSDdisturbedthenor-
maldevelopmentoftheirprofessionalactivitieswas assessed.
TheNordicSensi® Chair
TheNSC(WellnessNordicA/S,Espergaerde, Denmark,Fig.1)isanelectricallyoperatedrockingchairwithbuilt-inmusicMusiCure® composed byNielsEje[26].Itisequippedwithanintegrated audiosystemwithmusicrecording.MusiCure® is usedinawidevarietyofdifferenttypesoftreatmentandresearchprojectssuchascardiacpatients, surgeryandrecoveryorpsychiatricpatientssuffering fromanxiety,depression,delirium,orsleepproblems [26].RecentlyMusiCure® hasalsobeenusedforthe treatmentofPwD[16].
Thisframeworkrequiresconsiderationofapersoncenteredapproachtofocustointerventionsthat haveagreaterlikelihoodofeffectingapositive influenceontheirqualityoflife.Asresearchdemonstrates,person-centeredinterventionscanbeeffective inreducingBPSDinPwDandhealthcareservice providersshouldbeencouragedtousepersoncenteredcareasanessentialpartoftreatmentwhen attemptingtoreduceBPSD[27].
TheNSChasthreedifferentprograms:Relaxfor deeprelaxation,RefreshforrecoveryandComfort forgentlerelaxation.A3.7kgfiberblanketincreases thefeelingofsecurityandrelaxation,whilehelpinguserstoperceivetheirownbody.Inadditionto musicalprogramming,theNSCprovidespredefined tactilestimulationandrockingmotion,forarelaxingmulti-sensoryexperience.Thisapproachcould facilitatetheachievementofabalancebetweenstim-
ulationandsensorycalmthatwouldcontributetothe effectivemanagementofBPSD.Allsettingscanbe easilycustomizedatthetouchofabutton.
Forthepurposesofthisstudy,theNSCRelaxfor deeprelaxationprogram(RelaxProgram)wasused. TheRelaxProgramlasts20min,duringwhichthe backrestdescendstoasemi-reclinedpositionthatis maintainedthroughouttheprogram.Thechairhas alsoafootrestthatcanberaisedandlowered.Atthe endoftheprogram,thebackrestreturnstothesitting position.Atthesametimethatthechairisrockingin alineardirection,thePwDperceivestheautomatic relaxationmusicalongwithtactilestimulationonthe back.
Studydesign
Thiswasa16-weekrandomized,parallel, single-blind,controlled,clinicaltrial(RCT).After assessmentsforeligibilityPwDwererandomly assignedtotwogroupsofequalsize:atreatment groupthatreceivedthreetimesaweekonesessionper dayof20minintheRelaxProgramoftheNSCand acontrolgroupthatdidnotparticipateintheactivity mentionedforthetreatmentgroup,butreceived,atthe sametimeandduration,thecareandactivitiesthat werepartofthedailyroutinesofthecenter,including groupsessionsofcognitivestimulation,trainingin activitiesofdailylivingorcommunicationtraining.
Basedonthemethodologyusedinpreviousstudies,weconsiderthatafrequencyofthreetimesper
weekwouldbeadequatetostudytheeffectofthe NSConBPSD[14–17].Aresearchteamfromthe InstitutoAndaluzdeNeurociencia(fourneuropsychologistsandonepsychiatrist)filledtheoutcomes measuresofthestudyresults.Theywereblindedto thegroupassignedtothepatients.Ananonymized databasewasgenerated.Thesafetyoftheinterventionwascloselymonitoredbyrelyingoncontinuous supervisionoftheinterventionbyskillednurseassistants.Duringthetreatmentsession,thenurseassistant remainednexttothePwD,ensuringthattheuser wassafe,relaxed,andcomfortablewhileseatedin theNSC.
The16-weekstudyextensionincludedafirst2weekpre-interventionphasefollowedbyasecond 12-weekinterventionphasewiththeuseoftheNSC andathird2-weekpost-interventionphasewithoutreceivingNSC.Giventhedurationofthestudy wechosetimepointsforassessmentaccordingto areasonablesequence:atpre-interventionphase (baseline,Time0),atmid-interventionphase(week 8,Time1),attheendoftheinterventionphase (week14,Time2),andtwoweeksaftercompletionoftheinterventionphasetocheckiftheNSC effectcontinued(week16,Time3).Aschematic chartoftheassessmentscheduleisshownin Fig.2.
Uponentryintothestudy,PwDwhomettheinclusioncriteriawererandomizedtothetreatmentgroup orthecontrolgroup.Randomizationwascarriedout byblocksgeneratingrandomnumberswithrepeti-
tion,oneperblock.Randomizationnumberswere assignedsequentiallyforallstudyparticipants.
Intervention
Inbothnursinghomes,thetreatmentwascarriedoutonweekdays,duringthedayshift.The chairswereplacedinaroomintendedexclusively forthetreatmentsessions.Tofacilitateconfidence andadherencewithintervention,PwDwerealways introducedtothechairbythesamenurseassistant. Tofacilitatetheadaptationtothetherapeuticprocess, participantswerecarefullyintroducedtothechair, e.g.,justsuggestingthemsitdownthefirsttime, carefullyrockthesecondtime,startofthefullprogramsessionthethirdtime.EachPwDhadtheirown scheduleofrockingchairusethroughoutthestudy.
Ethicsapprovalandconsenttoparticipate
ThestudyprotocolwasapprovedbytheM ´ alaga ResearchEthicsCommittee(Approvalnumber: 03/2022ICPS3).ThisstudyisregisteredonClinicalTrials.govwiththeidentifierNCT05706792on January31,2023.Awritteninformedconsentwas signedbyPwDwhowereabletogiveortheirlegal representative.Informedconsentwasalsorequested fromcarestaffwhoparticipatedinthestudy.The studyfollowedtheethicalstandardsadoptedbythe DeclarationofHelsinkiinitslatestversion(Fortaleza,Brasil,2013)andwasconductedinaccordance withthestandardsofGoodClinicalPractice,as describedintheTripartiteHarmonizedStandardsof theInternationalConferenceonHarmonisationfor GoodClinicalPractice1996.
Outcomes
TheprimaryefficacymeasurewastheNeuropsychiatricInventory-NursingHome(NPI-NH)[28]that isaninstrumenttobeusedbythenursingstaff toevaluateneuropsychiatricsymptomsinPwDin thenursinghomesetting.TheNPI-NHiscomposedof12domainsthatratethemostfrequent BPSDindementiapatients(delusions,hallucinations,agitation,depression,anxiety,euphoria,apathy, disinhibition,irritability,aberrantmotorbehavior, sleepdisturbances,andappetitechanges).Ifasymptomwaspresentduringthepreviousmonth,each itemwasscoredforfrequency(range0–4)andseverity(range0–3)andtransformedtoatotalcomposite score(frequencyxseverity,range0–12).Wecal-
culatedthetotalNPI-NHscoreasthesumoftotal compositescores(range0–144).HigherscoresindicatemoresevereBPSD.Forthepurposesofthis study,totalscoreontheNPI-NHandthe12domains wereconsideredasprimaryefficacymeasures.In thisstudytheNPI-NHhadaninternalconsistency ofCronbach’s of0.67.Theinternalconsistencyof NPI-NHdomainswerebetween0.87and0.41.The agitationandapathydomainshadthehighestscores ofinternalconsistency,with0.87.Sleepdisturbances obtainedthelowestscorewith0.41.
SecondaryefficacymeasureswereCohenMansfieldAgitationInventory(CMAI)[29]and CornellScaleforDepressioninDementia(CSDD) [30].TheCMAIiscomposedof30itemsthatform foursubscales:psychicallyaggressivebehaviors, non-psychicallyaggressivebehaviors,verbally aggressivebehaviors,andnon-verballyaggressive behaviors.TheCMAIalsoincludesthefrequency andtheseverityoftheagitation-correlatedbehaviors andallowstoquantifytheagitatedbehaviorsin acontinuousmeasure,whichissensitivetothe changes.Cronbach’s fortheCMAIwasfoundto be0.86forthisstudy.
TheCSDDisa19-itemsemistructuredinterview designedtoassessdepressioninPwDwithscores above10indicatingapossibledepressionandscores above18suggestingadefinitivedepression.Inthis studytheCSDDhadhighinternalconsistencyof 0.84.
Likewise,anassessmentofcognitivefunctions, functionalcapacity,andqualityoflife(QoL)of PwDwascarriedoutusingtheSevereMini-Mental StateExamination(S-MMSE)[31],theBedford AlzheimerNursing-SeverityScale(BANS-S)[32], andtheQualityofLifeinLate-stageDementia (QUALID)[33].TheS-MMSEassessesthecognitive deteriorationinadvanceddementia.Itiscomposed of10itemsandthescorecanreach30points.The S-MMSEhadahighreliabilityaccordingwitha Cronbach’s =0.88forthisstudy.TheBANS-Sconsistsof7itemswith4categoriesthatenablesto discriminatechangesinadvancedphasesofdementia.Thescorerangesfrom7(noimpairment)to28 (totalimpairment).ItassessesthePwDabilityto performthreedailyactivities(dressing,eatingand mobility),theirabilitytospeak,theirabilitytomaintainvisualcontact,theregularityoftheirsleep-wake cycleandthestateoftheirmuscles.TheBANS-Shad aCronbach’s =0.81.
TheQUALIDisratedbythecarestaffwhohashad significantcontactwiththepatientovertheprevious
weekandconsistsof11itemsandevaluatesthree domains:affectivestate,comfort,andbasicactivities oflife.Scorerangesfrom11to55,withlowerscores beingthehighestqualityoflife.Thescalehadhigh internalconsistencywithacoefficientalphaof0.80 forthisstudy.
Finally,theassessmentofoccupationaldistress forthecarestaffwascarriedoutbymeansof theOccupationalDisruptivenesssubscaleofthe NeuropsychiatricInventory-NursingHome(NPINH-OD).Itassessesthegradeofself-reported professionalcarestaffburden.Carestaffratesthe extenttowhicheachofthe12behaviorsdisruptsthem and/orgeneratemorework.Scorerangesfrom0to 5points(fromnotatalltoveryseverely).WecalculatedthetotalNPI-NH-ODscore(range0–60).The NPI-NH-ODsubscalehadaninternalconsistencyof =0.68.
Statisticalanalysis
Demographicvariableswerereportedusingthe mean,standarddeviationinthecaseofquantitative variables;andnumberandpercentageforqualitative variables.Baselinedifferencesbetweenthetwotreatmentgroupswereassessedbyananalysisofvariance (ANOVA)ornonparametrictests,asappropriate.
AMixedEffectsModelAnalysisforRepeated Measurements(MMRM)wascarriedoutinorder toevaluatechangesinneuropsychiatric,cognitive, andfunctionalscoresandtohandlemissingvalues insomeofthefollow-upassessments.Theeffectof time(betweenthemeanbaselinemeasurementsand eachtimepoint),treatmentandinteractionbetween timeandtreatmentwereevaluated.Thechangescores atTime1andatTime2andthemeanchange scoresdifferenceswithinandbetweengroupswere calculatedfromtheMMRM.Allanalyseswerecontrolledfordemographicandclinicalcharacteristics thatapproachedsignificanceonunivariateanalysis. Posthoc analysesformultiplecomparisonswere conductedusingBonferroni´scorrection.Cohen’s d standardizedeffectsizeswerecalculatedanddefined assmall d =0.20,medium d =0.50andlarge d =0.80 [34].Themainefficacyanalysiswasbasedonthe ModifiedIntent-to-Treat(mITT)populationusinga LastObservationCarriedForward(LOCF)imputation.ThismITT-LOCFpopulationwaspre-definedas allrandomizedPwDwhoreceivedatleastoneweek oftheNordicSensi® Chairtreatmentandhadabaselineandatleastonepost-baselineassessmentforthe primaryefficacyvariableontreatment.
MMRManalysisdidnotincludethetwoweeks post-interventiondata.Aftercompletionofthe12 weeksofinterventionperiod,Student’s t-testwas usedtocomparewithin-groupmeanscoredifferences atTime2andTime3.
StatisticalanalyseswerecarriedoutusingtheStatisticalPackagefortheSocialSciencesSoftware (SPSS25.0,IBMCorporation,Armonk,NY,USA) andthesignificancelevelwassetat0.05.ForMMRM analysesoftheprimaryefficacymeasureasignificancelevelof p ≤ 0.004wasconsideredsignificant.
RESULTS
Demographicandbaselinescores
Eighty-eightPwDwereenteredintothestudyand wererandomized.Inthefirstweekoftheinterventionphase,2participantsdroppedoutbecauseof occasionaldizzinessthatworsenedwhensittingin thechairand3refusedtocontinuewiththestudy becausetheydidnotenjoysittingintheNSC.Six otherparticipantsdiedbeforethefirstpost-baseline assessment.ThemITT-LOCFpopulationcomprised 77PwD,allofwhomcompletedthe12-weekinterventionphase(Fig.3).Ofthese77PwD(65female, 12male),40(52%)wereinthetreatmentgroup(37 female,92.5%),and37(48%)wereinthecontrol group(28female,75.7%).PwDhadameanageof 81.77 ± 8.69years(range47–102)withmedianof 82yearsandmeanyearsofeducationof7.31 ± 3.24 (range6–18).AllparticipantswereCaucasian.The mainefficacyanalysisdidnotincludethe2-week post-interventionperiod.
Atbaseline,therewerenostatisticallysignificantdifferencesbetweenthetwogroupsforthe demographicandclinicalvariablesexceptforsex (women,84.4%, p =0.042)andanxiolyticuse(benzodiazepines;higherinthecontrolgroup,67.6%than inthetreatmentgroup,32.5%, p =0.002)(Table1). Nodeathsorseriousadverseeventsoccurredduringthestudy.CarestaffinformedthatNSCwaswell acceptedandtoleratedwithnodifferencesthrough differentstagesofGDS.
ThemostcommoncauseofdementiawasAD(46 participants,59.7%)followedbyvasculardementia(7participants,9.1%),frontotemporaldementia (3participants,3.9%),Lewybodydementia(2 participants,2.6%),andothertypesofdementia (19participants,24.7%).Therewerenostatisticallysignificantdifferencesbetweenthetreatment groupandthecontrolgroupfordementiadiag-
noses(χ2 =3.560, p =0.469)orseverityofdementia (χ2 =4.240, p =0.375).Neuropsychological,neuropsychiatric,andfunctionalperformanceofpatients atbaselineisshowninTable2.
Primaryefficacymeasure
ResultsfromtheMMRMforbothgroups arepresentedinTable3.TheMMRManalysisshowedastatisticallysignificanttimeby treatmenteffectforNPI-NHtotalscore(F(1, 75)=5.523, p =0.022),agitation(F(1,75)=0.817, p =0.002),apathy(F(1,75)=3.931, p =0.013),disinhibition(F(1,75)=3.704, p =0.021),irritability (F(1,75)=5.115, p =0.027),aberrantmotorbehav-
ior(F(1,75)=2.431, p =0.039),andeuphoria(F(1, 75)=3.817, p =0.026).TheMMRMdisplayedthe samesignificantresultswithandwithoutsexand benzodiazepinesadjustment.
TheNSCgroupperformedbetterthanthe controlgroupatTime2intheNPI-NHtotal score(meanchangescore–18.87 ± 5.56versus –1.74 ± 0.67, p =0.004),agitation(meanchange score–2.32 ± 2.02versus–0.78 ± 1.44, p =0.003), andirritability(meanchangescore–3.35 ± 2.93 versus–1.42 ± 1.31, p =0.004)andshowedan improvementalreadyatTime1inallofthem.The NSCgroupperformedbetterthanthecontrolgroupat Time1ineuphoria(meanchangescore–1.43 ± 2.18 versus0.23 ± 0.89, p =0.004),apathy(meanchange
DemographicandclinicalcharacteristicsofPwDatbaseline
Married12(15.6)6(15)6(16.2)
Single/divorced14(18.2)6(15)8(21.6)
48(10.4)4(10)4(10.8)
515(19.5)6(15)9(24.3)
635(45.5)17(42.5)18(48.6)
719(24.7)13(32.5)6(16.2)0.375 Hypertension48(62.3)23(57.5)25(67.6)0.362
Diabetesmellitus10(13)3(7.5)7(18.9)0.136
Psychiatrichistory30(39)18(45)12(32.4)0.379
Familyhistoryofdementia5(6.5)4(10)1(2.7)0.389
Ongoingmedication
AChEI14(18.2)6(15)8(21.6)0.404
Memantine21(27.3)13(32.5)8(21.6)0.456
AChEI+Memantine18(23.4)11(27.5)7(18.9)0.462
Antidepressants51(66.2)25(62.5)26(70.3)0.441
Benzodiazepines38(49.40)13(32.5)25(67.6)0.002
Neuroleptics41(53.2)20(50)21(56.8)0.553
Hypnotics28(36.4)14(35)14(37.8)0.796
Valuesaremean ± SDornumber(%).Independentsamples t-testwereusedforcontinuousdataand χ2 oncategoricaldata.PwD,people withdementia;NSC,NordicSensi® Chair;GDS,GlobalDeteriorationScale;AChEI,acetylcholinesteraseinhibitors.
Table2
Neuropsychological,neuropsychiatric,andfunctionalperformanceofPwDatbaseline
VariableOverall(n =77)NSCgroup(n =40)Controlgroup(n =37) p
Valuesaremean ± SD,Independentsamples t-testwereusedforcontinuousdata.NSC,NordicSensi® Chair;NPI-NH,Neuropsychiatric Inventory-NursingHome;NPI-NH-OD,NeuropsychiatricInventory-NursingHomeOccupationalDisruptiveness;CSDD,CornellScalefor DepressioninDementia;CMAI,CohenMansfieldAgitationInventory;BANS-S,BedfordAlzheimerNursing-SeverityScale;QUALID, QualityofLifeinDementiaScale;S-MMSE,SevereMini-MentalStateExamination;PwD,PeoplewithDementia.
Table3
Resultsfromthemixedeffectsmodelanalysisforrepeatedmeasurements
NSCgroup(n =40)Controlgroup(n =37)Between-groupdifferencesinmeanchangescore VariableMeanchangescorefrombaselineMeanchangescorefrombaseline
atT1atT2p # d atT1atT2p # d atT1p # d atT2p d
NPI-NH–16.89(9.65)–18.87(5.56)0.0030.250.25(0.12)–1.74(0.67)0.457–17.140.0010.56–17.130.0040.61 Delusions–0.96(1.51)–1.63(1.52)0.0040.440.02(0.21)–1.08(0.99)0.351–0.980.672–0.550.398 Hallucinations–0.82(1.33)–1.15(1.42)0.0210.23–0.08(1.22)–0.54(1.11)0.860–0.740.214–0.610.662 Agitation–1.47(1.41)–2.32(2.02)0.0020.48–0.45(1.32)–0.78(1.44)0.452–0.020.0030.29–1.540.0030.37 Depression–0.87(1.24)–0.95(1.78)0.399–0.12(0.89)–0.58(1.42)0.783–0.750.429–0.370.771 Anxiety–1.49(1.67)–2.16(2.68)0.0010.30–0.38(0.63)–0.86(0.91)0.429–1.110.321–1.300.449 Euphoria–1.43(2.18)–1.40(1.99)0.0020.100.23(0.89)–0.56(1.12)0.785–1.660.0040.39–0.840.126 Apathy–2.75(1.89)–3.04(2.78)0.0010.120.43(0.82)–1.74(1.96)0.294–3.180.0040.43–1.300.441 Disinhibition–2.12(2.01)–2.03(1.93)0.010.050.19(0.91)–0.94(1.56)0.632–2.310.0030.51–1.090.167 Irritability–2.99(2.11)–3.35(2.93)0.0010.160.19(0.22)–1.42(1.31)0.098–3.180.0010.45–1.930.0040.49 Aberrantmotorbehavior–1.14(1.99)–0.80(1.87)0.4770.61(1.76)–0.68(1.98)0.611–1.750.0030.20–0.120.662 Sleepdisturbances–1.05(2.02)–1.09(2.24)0.221–0.61(1.96)–1.44(2.22)0.057–0.440.5580.350.621 Appetitechanges–0.78(1.89)–0.16(1.12)0.6790.46(1.67)0.03(1.01)0.669–1.240.556–0.190.278 CSDD–2.47(2.49)–5.74(5.22)0.0220.460.38(0.22)–4.40(3.34)0.080–2.850.662–10.140.941 CMAI–12.79(6.11)–17.72(8.23)0.0010.685.54(3.31)–6.70(3.02)0.571–18.330.0010.46–11.020.0020.44 NPI-NH-OD–6.45(4.21)–9.67(7.67)0.0010.52–0.56(0.48)–7.66(6.08)0.055–5.890.0010.18–2.010.0030.21 Theresultsdisplayedareadjustedforsexandbenzodiazepinesuse.Valuesaremean(standarddeviation); d,Cohen’s d effectsize; # d,effectsizefromT0toT2.NSC,NordicSensi® Chair;NPI-NH, NeuropsychiatricInventory-NursingHome;CSDD,CornellScaleforDepressioninDementia;CMAI,CohenMansfieldAgitationInventory;NPI-NH-OD,NeuropsychiatricInventory-Nursing HomeOccupationalDisruptiveness.
Fig.4.Meanchangesfrombaselineasestimatedbythemixedmodel.NSC,NordicSensi® Chair;NPI-NH,NeuropsychiatricInventoryNursingHome;AMB,Aberrantmotorbehavior;CMAI,CohenMansfieldAgitationInventory;NPI-NH-OD,NeuropsychiatricInventoryNursingHomeOccupationalDisruptiveness.
score–2.75 ± 1.89versus0.43 ± 0.82, p =0.004), disinhibition(meanchangescore2.12 ± 2.01versus 0.19 ± 0.91, p =0.003),andaberrantmotorbehavior (meanchangescore–1.14 ± 1.99versus0.61 ± 1.76, p =0.003)(Fig.4).
Concerningthewithin-groupchanges,NPI-NH meanchangescoreandmeanchangescoresfordelusions,hallucinations,agitation,anxiety,euphoria, apathy,disinhibition,andirritabilityshowedstatisticallysignificantdifferencesattheendofthe interventionperiod(Time2)frombaseline.There werenostatisticallysignificantdifferencesineach ofthesevariableswhencomparingmeanscoresat Time2andTime3(Table3).
Secondaryefficacymeasures
RegardingtheCMAI,theMMRManalysisshowed astatisticallysignificantinteractioneffectbetween timeandtreatment(p =0.021).TheNSCgroupperformedbetterthanthecontrolgroupatTime2(mean changescore–17.72 ± 8.23versus–6.70 ± 3.02, p =0.002)andshowedanimprovementalreadyat Time1(Fig.4).TheNSCgroupshowedastatistically significantdifferenceattheendoftheinterventionperiod(Time2)frombaseline.Therewasno significantdifferenceinCMAIintheNSCgroup whencomparingmeanscoresatTime2andTime 3(Table3).
TheMMRManalysisshowednostatisticallysignificantinteractioneffectbetweentimeandtreatment fortheCSDD(F =1.071, p =0.304).Therewere nosignificantdifferencesbetween-groups.TheNSC groupshowedastatisticallysignificantdifference attheendoftheinterventionperiodfrombaseline. TherewasnosignificantdifferenceinCSDDinthe NSCgroupwhencomparingmeanscoresatTime2 andTime3(Table3).
Cognitiveperformance,functionalstatus,and qualityoflife
WithregardtotheS-MMSEneithertheNSCgroup (meanchangescore5.59 ± 5.66versus7.43 ± 8.17, p =0.812)northecontrolgroup(meanchangescore 6.67 ± 9.28versus10.61 ± 7.34, p =0.443)showed statisticallysignificantdifferencesattheendof thetreatmentperiodfrombaseline.Concerningthe BANS-StheNSCgroupshowedstatisticallysignificantimprovementattheendoftheinterventionperiod frombaseline(meanchangescore15.62 ± 6.01versus17.97 ± 4.92, p =0.05).Therewasnosignificant differenceinBANS-SintheNSCgroupwhencomparingmeanscoresatTime2andTime3(p =0.263). InregardtotheQUALIDtheNSCgroupshoweda statisticallysignificantimprovementattheendofthe treatmentperiodfrombaseline(meanchangescore 19.59 ± 8.77versus25.83 ± 8.12, p =0.003).There wasnosignificantdifferenceinQUALIDintheNSC groupwhencomparingmeanscoresatTime2and Time3(p =0.467).
Occupationaldisruptiveness
ConcerningtheNPI-NH-OD,theMMRManalysisshowedastatisticallysignificantinteractioneffect betweentimeandtreatment(p =0.042).TheNSC groupperformedbetterthanthecontrolgroupat Time2(meanchangescore–9.67 ± 7.67versus –7.66 ± 6.08, p =0.003)andshowedanimprovement alreadyatTime1(Fig.4).TheNSCgroupshowed astatisticallysignificantdifferenceattheendofthe interventionperiodfrombaseline(Table3).There wasnosignificantdifferenceinNPI-NH-ODinthe NSCgroupwhencomparingmeanscoresatTime2 andTime3(Table3).
DISCUSSION
Thisstudywasperformedtoexploretheefficacy oftheNSCinthetreatmentofBPSDinnursinghome
residentswithmoderateandseveredementia,primarilyoftheAlzheimer’stype.Thetreatmentwiththe NSCwaswelltoleratedandwasassociatedwitha beneficialeffectonoverallBPSD.PwDtreatedwith theNSCshowedstatisticallysignificantsuperiority ontheNPI-NHoverPwDinthecontrolgroup.
TheNSCshowedbenefitsinmostofBPSD. Notably,itsuseyieldedsignificantbenefitregarding agitation,apathy,irritability,disinhibition,aberrant motoractivity,andeuphoriaoverthe12-weekof treatment.Consistentwiththesignificantreductionin theNPI-NHagitationdomainscore,wealsofounda significantdecreaseintheCMAIscore.Importantly, theNPI-NH-ODtotalscoreimprovedsignificantly inthetreatmentgroup.Inaddition,ourfindingsalso showedsignificantimprovementintheresidents´ functionalstatusandqualityoflifeover12weeks.
Previousstudieshavehighlightedthattheuseof arockingchairhaspotentialbenefitsinthetreatmentofBPSD,whiledemonstratingaverylowrisk ofharm[14–16].Theefficacyinimprovingthepsychologicalwell-beingandbalanceusingaplatform rockingchairwasexaminedin25PwDadmitted tonursinghomesfor6weeks[14].PwDshowed smallimprovementsindepression,anxietyandpain medicationusebutfoundnoimprovementinagitation.Inaquasi-experimental,repeated-measures designstudy[15]theeffectsofagliderswingon emotions,relaxation,andaggressivebehaviorsina groupof30nursinghomeresidentswithdementia wereevaluatedfor10days.Thegliderintervention significantlyimprovedemotionalstateandaggressivesymptomswereobservedtodecreasefromthe beginningoftreatmentuntilaftertheendoftreatment. Morerecently,inasingle-casestudy[16],performed usingamixed-methodsapproach,sixPwDinanursinghomesettingusedtheNSCforameannumber offivetimesperweek,foreightweeksintotal.The resultsindicatedadecreaseinBPSDsymptomsand increasedqualityoflifeuponusingtheNSC.
Therefore,basedonourfindingsandthoseprovidedbyearlystudies,apotentialtherapeuticroleof theNSCinthetreatmentofdementiaBPSDbased onitsabilitytoofferpatients,inanintegratedway,a sensoryexperiencethatbringsthebenefitsofmusic therapy,therapeutictactilestimulation,vestibular stimulation,multi-sensorystimulationandrelaxation shouldbeconsidered.Althoughlessandlessfrequently,sometimesPwD,especiallythosewhoare institutionalized,maybeinasituationofsensory deprivationor,conversely,exposedtoexcessiveenvironmentalstimulation,whichmaycontributetotheir
experiencingasenseofintrapsychicdiscomfort,thus favoringtheonsetofBPSDsuchasagitation,anxiety orirritability[35,36].Therefore,interventionswith residentsshouldfacilitatetheachievementofabalancebetweenstimulationandsensorycalm[12].In thissense,proceduresthatfavormultisensorystimulationsuchastheNSCareaveryappropriateoption inthesepatientsandcancontributetoachievearelaxingandstimulatingenvironmentatthesametime [37,38].
AscarestaffstatedtheNSCwasconsideredan affordable,easytouse,nonlabourintensiveinterventioninthecareofPwD.Whencarestaffwas askedtowhatextenttheuseoftheNSChelped them,mostbelievedthatitimprovedthequality ofcare,freedupstafftimeandcontributedtoa calmerandmorepleasantenvironmentforeveryone.Carestaffinthetreatmentgroupbenefitedfrom thebehavioralimprovementthatpatientsexperienced andreportedlessoccupationaldisruptivenessonNPINH-ODscoresthanstaffinthecontrolgroup.Thisis consistentwithresearchshowingtherelevantrolethat thepresenceofBPSDhasontheburdenofnursing homestaff[39,40].
Inthesameline,toevaluatecaregiveropinion, amulticentersurveywasconductedamonglong termcarefacilitiesinseveralEuropeancountries. Carestaffreportedtheiropinionoftheutilityofthe NSCinthemanagementofBPSD.Mostrespondents believedthatthequalityofcareprovidedimproved, theyhadmoretimeforcareandhelpedcreateacalmer environmentandpatientfriendly[17].
Interestingly,PwDintheNSCgroupshowed significantimprovementinfunctionalcapacityand qualityoflifeasmeasuredbytheBANS-Sand QUALIDat14-weekfollow-up.QualityoflifeisdifficulttomeasureinPwD,butitisbelievedtobe influenced,amongothersfactors,bythepresence ofBPSD[41].Thesebenefitscouldberelatedto thelong-terminterventionandperson-centeredtherapeuticprocessdevelopedinthisstudy,whichbetter matchingspecificinterventionstospecificindividuals.Applyingthismultisensoryapproachbasedon thespecificstimuliofferedbytheNSCandaccompanyingsupportfromthededicatednurseassistant enhancesthepersonalizationofinterventionsfor participantsandincreasesthechanceofefficacious findings.ThespecificstimuliofferedbytheNSCand developedthroughindividualizedcareinfeasibleand structuredsessionswerewellaccepted,withnonegativeeffects.Thisisinlinewithotherresultsshowing thatperson-centeredinterventionsshoweffectson
reducingBPSDandimprovingqualityoflifein dementiacare[42,43].
Whenconsideringtheresultsofanintervention, itisimportanttoconsidernotonlystatisticallysignificantimprovementsbutalsoclinicallysignificant efficacy.Forthispurpose,itisnecessarytocompare theobservedchangeswithdifferencesthatareconsideredclinicallyrelevant.Forclinicaltrialsindementia oftheAlzheimer’stype,ithasbeenassumedthatdifferencesassmallas4.5pointsontheNPI-NH[44]are clinicallyrelevant.Inourstudy,averagedifferences thatweobservedonNPI-NHoverthe12weeksstudy periodexceededthisclinicallyrelevantdifference (meandifferencewithingroup=–19.92pointsand meandifferencebetweengroups=–16.28points).In addition,themagnitudeoftheobservedeffecton BPSDcouldbecontextualizedusingstandardized effectsizes.Inlinewiththis,theclinicalrelevance ofthesignificanteffectoftheNSConbehavioraltest scorescouldbesupportedbythemagnitudeofthe betweengroupeffectsizeswithamedianCohen’s d of0.51.
AstrengthofthisworkcomparedtopreviousstudieswasthehighernumberofPwDevaluatedand itsdesignasaRCT.Inaddition,theparticipantsin thestudyunderwentacomprehensivebehavioraland functionalevaluationwithwidelyusedoutcomemeasuresfocusedonreducingobservationbias.However, herearealsosomelimitationsthatshouldbeconsidered.Thisstudywascarriedoutintwositesand, thereforethegeneralizationofitsfindingstoother settingsandPwDshouldbeinterpretedwithcaution. Althoughtheresearchteamwasblindedtothegroup assignedtothePwD,theoutcomemeasureswere obtainedfromcarestaffwhowerenotcompletely blindedtotheintervention.Asaresult,although mucheffortwasputintomitigatingbias,itisnecessarytoconsiderthepossiblebiasfromthecarestaff whenreportBPSD.Itwasnotfeasibleforthestaff memberstobecompletelyunawareoftheexperimentalconditionofthePwD,andthiscouldhavebiased theratingsontheevaluationinstruments.Although carestaffwasnotpresentduringthetreatmentdeliverytheycouldhavereceivedanecdotalinformation fromotherstaffmembers.
Anotherpotentialsourceofbiascomesfrom theassessmentofalloutcomemeasuresthatwere answeredbythecarestaff.Acriticalpointabout person-centeredapproachesisthatinterventionstargetingBPSDshouldbetailoredtoeachindividualand circumstances,whichchangeandpossiblyreflectdifferentunmetneedsovertime.Infact,tailoringmusic
toindividualpreferencesseemstobemoreeffectiveatreducingBPSD(e.g.,agitation)thanapplying genericclassicalorrelaxationmusic.Itshouldalso benotedthattheapplicationofthisapproachmay providemorespecific,butlessgeneralizable,results. Finally,weacknowledgethepotentialforassessment bias,asPwD(andevenstaffmembers)gotmore attentiontothemselvesthroughouttheintervention period,i.e.,HawthorneEffect.
Conclusions
Theseresultsmayhaveclinicalsignificancein choosingnon-pharmacologicaltherapiesforBPSD inPwD.ThereductioninoverallBPSDalongwith decreasedincaregiveroccupationaldisruptiveness andimprovedqualityoflifeforresidentssuggest thattheNSCrepresentsanencouragingnewnonpharmacologicalapproachtoimprovingBPSDof nursinghomeresidentswithdementia.Theresults suggestthatNSCisaninterventionwithpotentialinterestforuseinnursinghomesaspartof thePwDcareplan.Thisstudyshouldinspirethe designoffuturelong-termrandomizedcontrolledtrialsthatcontributetosupportingtheuseoftheNSCas anon-pharmacologicalperson-centeredintervention forimprovingBPSDinPwDinnursinghomes.
ACKNOWLEDGMENTS
TheauthorswishtothankARJOforprovidingthe NSCforthisstudy.Wewishtothankpatientsand caregiversfortheirparticipationinthestudy.There wasnofinancialcompensationforeitherthepatients orthestaffofthetworesidencesthatparticipatedin thestudy.TheNSCwasprovidedforthestudypurposesonlyandwasremovedfromthenursinghomes byARJOattheendofthestudy.
FUNDING
Theauthorshavenofundingtoreport.
CONFLICTOFINTEREST
Theauthorshavenoconflictofinteresttoreport.
DATAAVAILABILITY
Thedatasetsusedand/oranalyzedduringthe currentstudyareavailablefromthecorresponding authoruponreasonablerequest.
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