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The doll therapy as a first line treatment for behavioral and psychologic symptoms of dementia in nursing homes residents: a randomized, controlled study

Abstract

Background

Patients living with dementia are severely affected by the development of behavioral and psychologic symptoms (BPSD) which represent a burden for patients and caregivers. The use of psychotropic drugs in the control of BPSD is widely diffused, however the use of a first line non-pharmacologic approach is highly recommended.

Here we evaluate the effect of doll therapy (DT) in the management of BPSD, on the reduction of caregiver burden and delirium incidence in nursing home residents by a randomized controlled trial.

Methods

We enrolled fifty-two nursing homes residents living with dementia and BPSD. Subjects were randomized to DT (26) or standard treatment (ST, 26), we measured BPSD, caregiver burden and delirium with standard clinical scales at baseline, after 45 and 90 days.

In order to evaluate the presence of BPSD we used Neuropsychiatric Inventory (NPI) scale and the A.Di.CO scale, the caregiver burden was measured by the Greutzner scale and delirium by the Confusion Assessment Method (CAM) scale.

Results

DT was more effective in reducing agitation and aggressiveness as respect to ST. Moreover DT globally reduced the presence of BPSD as dysphoria, wandering and apathy. We observed a significant reduction of the professional caregiver burden and the incidence of delirium was significantly reduced in subjects treated with DT.

Conclusions

We show that DT is more effective that ST in the control of BSPD in patients affected by moderate to severe dementia. Moreover we suggest that DT may effective in reducing the incidence of delirium.

Trial registration

Retrospectively registered in ClinicalTrials.gov the 10th June 2, 2021 trial registration number NCT04920591.

Peer Review reports

Introduction

During the clinical course of dementia, the appearance of behavioural and psychologic symptoms (BPSD) [1,2,3] severely worsen the burden of the disease. More than 80% of patients living with dementia will experience the development of BPSD, which often will cause institutionalization. BPSD include agitation, elation, wandering, depression, delusions and hallucinations [4, 5], these symptoms are difficult to manage with standard pharmacologic approach and represent a serious problem both for families and for professional caregivers in nursing homes [6, 7]. The presence of BPSD often leads to the use of multiple psychotropic drugs, as a consequence patients are exposed to severe adverse events with scarce therapeutic effect [4, 8]. Psychotropic drugs increases mortality [9] and reduce patients’ physical [10, 11] and cognitive performances [12]. De-prescribing has been proposed in order to reduce severe adverse events within a multicomponent intervention, showing improved health outcomes in old patients affected by cognitive impairment and BPSD [13]. Together with de-prescribing, several guidelines recommend the use of non-pharmacologic interventions as first line treatment for BPSD [14,15,16].

Amongst non-pharmacologic intervention, doll therapy (DT) has been proposed as an useful tool to reduce BPSD in patients affected by moderate to severe dementia, mostly in nursing homes [17]. Previous studies suggested that DT is useful in reducing agitation, psychotropic drug administration and in increasing patients’ quality of life [17,18,19]. However, despite some interesting results, published studies are mainly cohort, case-control and observational or exploratory studies [17, 20, 21].

Although the mechanism of action of DT is not fully explained, the attachment theory [21,22,23] has been evoked in order to explain its efficacy in the control of BPSD [21, 24]. Attachment behaviour is the tendency of every person to seek for protection and physical closeness when feeling vulnerable, this tendency persist during the whole life [25], and is particularly important in patients affected by dementia. During the course of the disease, patients become more vulnerable and some of the BPSD as wandering, dysphoria, anxiety, agitation and even aggressiveness might be interpreted as attachment requests. In this condition the doll, perceived as a translational object [19, 21, 24], catalyze patients’ attention and, hence, may reduce the attachment requests [26]. The observation of patients affected by dementia interacting with the doll shows that they treat the doll as a real baby needing care and hence they might replace their attachment request with caregiving behaviours. Frequently patients interact with the doll taking care of her needs, reassuring and lulling her. Following this theory we postulated that DT may also reduce the incidence of delirium catalyzing patients’ attention.

Despite the theoretic premises and some interesting experimental data, we are in need of controlled clinical trials to support the clinical efficacy of DT in the control of BPSD, in the reduction of caregiver burden and in the reduction of delirium.

The present study evaluate, with a randomized controlled approach, the efficacy of DT as respect to standard clinical approach in the management of BPSD, in the reduction of caregiver burden and in the reduction of delirium incidence in patients affected by moderate to severe dementia living in nursing homes.

Methods

Study design

This is a randomized controlled trial with two parallel arms, here we assess the effect of DT compared with Standard clinical Treatment (ST) on BPSD and on the caregiver burden in persons with dementia residents in two Italian nursing homes. The Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-pharmacologic treatments has been applied [27].

Ethical considerations and consent to participate

The Ethical Committee “Comitato Etico Interaziendale AO Città della Salute e della Scienza di Torino” approved the study (Ref. no. CE il 04/10/2018 protocol number 0098548). Written informed consent was obtained from all the participants, in patients with impaired capacity to consent a proxy consent was obtained.

Participants

Patients residents in two Italian nursing homes (“Casa di Riposo Borsetti Sella Facenda in Mosso Biella (BI) and the “Residenza per anziani Don Giuseppe Eandi” in Lagnagsco (CN)) were enrolled in the study between the 1 January 2019 and 31 October 2019 according with the following inclusion/exclusion criteria.

Inclusion criteria

Age ≥ 65 years; diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2; presence of agitation and/or aggressiveness defined as A.Di.Co score ≥ 2; manual and visual abilities sufficient to interact with the doll.

Exclusion criteria

Age < 65 years; patients/relative refuse to participate; mild forms of dementia (CDR < 2); contraindication for DT; life expectancy lower than 3 months; negative interaction with the doll.

The experience of mournful events related to parental experience is considered a contraindication for the DT [28].

Patients were randomly assigned to DT or ST, the randomization was carried on computer-generated tables by the principal investigator; the patients received a consecutive number after enrolment and were subsequently allocated to randomization list, as described by Kim and Shin [29].

Intervention

The doll used in the study is the “empathy doll” (Fig. 1), nurses responsible for doll administration received detailed information on the aim of using DT and on the study procedure. The intervention has been fully described in our previous study [30]. The investigators informed professional and family caregivers on the mean and efficacy of DT in patients affected by dementia and BPSD, the caregiver were allowed to ask questions and received detailed answers, the concern about possible infantilization of the patients has been clearly addressed and discussed. At the end of the discussion an informative brochure on BPSD in dementia and on the role of DT was given to the caregivers, as described in our previous study [30].

Fig. 1
figure1

Empathy dolls. The pictures show the dolls used in the study (panel A), interaction between patient and doll (panel B)

The patients’ interaction with the doll was evaluated with standard methods using the Engagement Observation Rating Tool for Doll Therapy, this tool is derived from the Observational Measurement of Engagement (OME) [31] and is described in details in [32]. Patients’ interaction with doll was observed for 7 days prior to randomization and rated on the first and the last day of the week. Patients with positive attitude towards the doll were included in the study and randomized to DT or standard treatment (ST). Patients with negative interaction (refuse the doll, become agitated and or aggressive) or neutral attitude (ignore the doll) were excluded from the study.

In DT group the doll were administered two times a day for 2 hours in the morning, 2 hours in the afternoon and pro re nata (PRN) in case of agitation, aggressiveness and /or wandering. The administration of DT was the first choice in case of agitation, aggressiveness and /or wandering; if the symptoms persist, the use of pharmacologic treatment was allowed and noted. The patient can freely interact with the doll and if he/she refuses the doll, the caregiver would not insist, this type of intervention has been described in details in [30].

In the control group, the caring physician freely chose the kind of pharmacological intervention, according with standard clinical care (ST). DT and controls were comparable for antipsychotic baseline treatment (Table 1).

Table 1 Antipsychotic treatment at baseline and after 90 days of follow-up according to randomization. Percentage and confidence of intervals (CI) are shown

Outcomes

Primary outcomes were the reduction of BPSD and the reduction of professional caregiver burden.

Secondary outcome was the reduction of delirium.

Analyzed variables

Presence of BPSD was evaluated with the Neuropsychiatric Inventory (NPI) scale [33] and with the A.Di.CO scale to specifically evaluate agitation and aggressiveness [30]. The A.Di.Co scale is a scale derived from the DISCO scale [34, 35], it evaluates the presence of BPSD using 10 items dived in clusters, the presence of moderate to severe agitation is scored 2.

The NPI scale was administered in a semi-structured interview setting with a close professional caregiver according with standard clinical practice described in [36]. The use of NPI allow us to evaluate the presence of several BPSD and to rate their frequency and severity. NPI evaluates different BPSD as described in [36, 37] and namely delusions, apathy, hallucinations, disinhibition, agitation/aggression, irritability, depression/dysphoria, aberrant motor behaviour, anxiety, night time behaviour disturbances, euphoria, and appetite and eating abnormalities. Each item receive a score on a 4-point scale for the frequency (0 = never, 1 = less than once a week, 2 = at least once a week, 3 = more than one a week, but less than once a day, 4 = every day). The severity of the symptom is evaluated on a 3-point scale ranging from 1 to 3 (1 = mild, 2 = moderate, 3 = severe (requires pharmacologic treatment). The distress of the caregiver regarding the behaviour is evaluated by a score ranging from 0 to 5 (0 = no stress, 1 = minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = very severe). The NPI total score ranges from 0 to 144 [36].

In order to specifically evaluate the professional caregiver burden the Gruetzner scale [38] was used, the presence of delirium was evaluated by the use of the Confusion Assessment Method (CAM) scale [39]. Cognition and functional status were evaluated by the Short Portable Mental Questionnaire (SPMQ) [40], the Activity of Daily Living (ADL) scale and the Instrumental Activity of Daily Living (IADL) score [41] respectively.

Age and gender were also recorded. Data analyses were blinded as respect to patients’ treatment.

Variables of interest were collected at baseline, after 45 and 90 days of intervention (Fig. 2).

Fig. 2
figure2

Study flow chart. The diagram shows the study design with the number of patients at each visit

Statistical analyses

As no previous study measured the efficacy of DT in using A.Di.CO and NPI, in the period of the study drawing, the power analysis was conducted using an estimated large effect size (f = 0.40), an alpha level of 0.05, and a power of 0.8. A sample size of 52 is necessary (26 each group) for primary outcomes [42].

All the analyzed variables were tested for normality by the kurtosis test and they were all normally distributed. Patients randomized to DT were compared to patients randomized to ST by one-way ANOVA for continuous variables and by χ2 test for gender. The effect of DT was evaluated per protocol using the two-way ANOVA for repeated measurements for continuous variables and by χ2 test for trends for the incidence of delirium.

SPSS 25.0 were used for the statistical analyses and p < 0.05 was considered statistically significant. Graphs were drawn using GraphPad 8.0 for Windows.

Results

Sixty-one residents in nursing homes were eligible to the study, of those 52 were recruited. Three residents refused to participate whereas six (9.6%) have a neutral or negative interaction with the doll, general characteristics of patients included in the study versus patients excluded were similar (data not shown).

The DT group did not significantly differs from patients in ST group for age, gender, cognitive performance, level of independence, presence of delirium, presence of BPSD; the only variable that significantly differs in the two groups was the professional caregiver burden measured by the Greutzner scale, which was significantly higher in DT group (Table 2). In order to correct for possible effects of baseline differences on the follow-up a Sidak’s multiple comparisons test was run-out, there were no significant difference in any of the analysed variables (data not shown).

Table 2 General characteristics of patients according with treatment group. Mean ± SE are shown, p values were calculated by one-way ANOVA and by χ2 test for gender

There were no dropouts during the study and the DT was well accepted during the whole study by patients and caregivers.

DT is effective in reducing BPSD and caregiver burden

DT was more effective in reducing agitation and aggressiveness as respect to ST, in particular we observed a significant reduction in the A.Di.Co score (Fig. 3 A) and in the items of NPI rating agitation (Fig. 3C). Moreover DT globally reduced the presence of BPSD as shown by the reduction of NPI global score (Fig. 3B), in particular we observed a significant amelioration of dysphoria (Fig. 3D), wandering (Fig. 3F) and apathy (Fig. 3E).

Fig. 3
figure3

Doll therapy is effective in the control of BPSD. Effect of DT versus ST on the control of BPSD measures by A.Di.CO (panel A), NPI global score (Panel B), NPI score for agitation (panel C), NPI score for dysphoria (panel D), NPI score for apathy (panel E), NPI score for wandering (panel F). Results of two-way ANOVA for repeated measurements are shown in the box, significant differences versus baseline are indicated by the star (*)

Eight patients out of 26 (30.7%) needed DT administration for appearance of agitation and aggressiveness. The DT was administered PRN 32 times and was effective in calming the patients 28 times (87.5%), in 4 occasion psychotropic drugs were needed to control BPSD.

We observed no significant difference in the kind of chronic antipsychotic treatment administration at baseline and after 90 days of follow-up in DT and ST groups (Table 1), nor in the dose used (data not shown).

Moreover, we observed a significant reduction of the professional caregiver burden (Fig. 4A).

Fig. 4
figure4

Doll therapy is effective in reducing the caregiver burden and the incidence of delirium. Effect of DT versus ST on the caregiver burden measured with the Greutzner scale (panel A) the results of two-way ANOVA for repeated measurements are shown in the box in panel A, significant differences versus baseline are indicated by the star (*). Incidence of delirium in DT group (panels B) and in ST group (panel C), both absolute number and percentage of patients is shown. Results for the χ2 test for trends are shown in the box

DT is effective in reducing incidence of delirium

As secondary outcome, we measured the incidence of delirium with the CAM scale; our hypothesis was that the doll, as transitional object, might catalyze patients’ attention and reduce the risk of delirium. Interestingly in the subjects treated with DT, incidence of delirium was significantly reduced (Fig. 4B).

Discussion

The use of doll treatment may be useful as a non-pharmacologic approach to control BPSD in patients with moderate to advanced forms of dementia [15]. Despite some evidences on the efficacy of this approach [17], its use is still not widespread because of some ethical concerns and lack of solid scientific evidences. Amongst the ethical concerns feelings of infantilizing the patient [43] and difficulties in finding the target patient for the treatment [44] have been raised.

In our study, after adequate information, no family nor professional caregiver rise objection and refuse the use of DT. We proposed the use of DT only after a careful observation of patients interaction with the doll, this observation allow us to exclude patients that have a neutral or negative interaction with the doll, thus maximizing the possible positive effects of the treatment and avoiding discomfort for the patients. We observed the interaction of the subjects with the doll for 7 days, during this period, only six subjects have a neutral or negative interaction, and none of them becomes aggressive and agitated after DT administration, they simply refuse the doll. We did not find significant differences between residents refusing and accepting the doll, hence we recommend proposing the doll and observing the patients reaction in order to choose the best candidates for the DT.

The lack of solid scientific evidences on DT is mainly due to the difficult in standardization of non-pharmacologic intervention; some attempt towards standardization of DT have been done with well-designed randomized controlled clinical trials [20, 45,46,47]. The randomized-controlled clinical trials agree on the efficacy of DT in ameliorating BPSD in nursing home residents. In particular Ylmaz & Asiret show a reduction in the agitation and others BPSD and an increase in the patients’ cognitive performance [47]. Here we show that DT was even more effective than ST in reducing agitation and aggressiveness. In our recent work on an acute care geriatric unit we observed the same effect over a shorter period [30].

Beside the effect on agitation and aggressiveness, we observed a reduction of dysphoria and wandering and an amelioration of apathy. The reduction of apathy and dysphoria observed in our study confirms the results of previous non randomized-controlled studies suggesting that DT may stimulate patients’ perception [28], ameliorating their communication abilities, their self-esteem and overall quality of life [48, 49]. Our data suggest that DT is also effective in controlling agitation and/or aggressiveness PRN, nevertheless, we do not find significant difference in chronic antipsychotic drugs during DT. The evaluation of change in chronic antipsychotic treatment was not stated as end point in our study, hence it is not possible to drawn significant conclusion from this observation.

Thanks to the effects on BPSD, DT significantly reduced the perceived professional caregiver burden; this might contribute to higher quality of care for persons living with dementia [50], hence this is one of the main goals of treating BPSD.

Delirium is common amongst older patients and the risk of developing delirium is increased by the presence of cognitive impairment [51, 52]. The prevention of delirium is of paramount importance, ameliorates patients clinical outcome and comfort [53, 54]. Non-pharmacologic approaches have been suggested for the prevention of delirium [53] and, although sparse, data currently available suggest efficacy for some tools as appropriate lighting, the use of calendar and clocks to reduce delirium incidence. Moreover, music therapy have been evaluated as possible tool to reduce delirium, a paper from Jonson and colleagues suggests that music therapy may reduce physiologic variations associated to delirium as hearth rate and systolic blood pressure, however it provides no direct evidence of delirium prevention [55].

This is the first study investigating the possible role of DT in the prevention of delirium in patients affected by dementia. Here we show that patients treated with DT have a lower incidence of delirium measured by the CAM scale. The exact mechanisms is currently unknown, we hypothesize that DT may act on one of the factors causing delirium, according with the Hospital Elder Life Program this are: orientation, therapeutic activities, early mobilization, vision/hearing optimization, oral volume repletion, and sleep enhancement [56]. Interaction with the doll may be considered as a therapeutic activity catalysing patients’ attention and reducing the risk of delirium.

As major limitation of our study, we acknowledged the interaction between the health care professionals and the patients at the moment of DT administration, we cannot exclude an effect of such interaction in calming down the patients. However also in the ST group the staff interact with the patient when administering the treatment, usually the health care professional explain to the patients the treatment that is about to receive and help him/her in taking the drugs, nevertheless this type of behavioral intervention was not standardized. On this regard, it is interesting to underline that the comparison of DT with common clinical practice allow us to generalize our findings.

We gave detailed information on potential benefit of the DT in subjects living with dementia to the nursing home staff, mainly to avoid the concerns about possible infantilization of the patients, however these information may led to detection bias. This limitation is intrinsic to the use of non-pharmacological intervention and to the use of scales that require an evaluation of the patients’ behavior to assess the intervention efficacy.

In conclusion, DT may be an option for the treatment of BPSD in nursing home residents affected by severe to moderate dementia providing a careful evaluation of doll acceptance both from patients and family. On this regard the professional caregiver must be formed in order to correctly present the treatment to the patient and his/her family.

Here we show, for the first time in literature, a possible effect of DT in reducing the incidence of delirium, these data needs to be further explore with an ad hoc designed trial.

Availability of data and materials

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. 1.

    Lyketsos CG, Carrillo MC, Ryan JM, Khachaturian AS, Trzepacz P, Amatniek J, et al. Neuropsychiatric symptoms in Alzheimer’s disease. Alzheimers Dement. 2011;7(5):532–9. https://0-doi-org.brum.beds.ac.uk/10.1016/j.jalz.2011.05.2410.

    Article  PubMed  PubMed Central  Google Scholar 

  2. 2.

    Geda YE, Schneider LS, Gitlin LN, Miller DS, Smith GS, Bell J, et al. Neuropsychiatric symptoms in Alzheimer’s disease: past progress and anticipation of the future. Alzheimers Dement. 2013;9(5):602–8. https://0-doi-org.brum.beds.ac.uk/10.1016/j.jalz.2012.12.001.

    Article  PubMed  PubMed Central  Google Scholar 

  3. 3.

    Ismail Z, Smith EE, Geda Y, Sultzer D, Brodaty H, Smith G, et al. Neuropsychiatric symptoms as early manifestations of emergent dementia: provisional diagnostic criteria for mild behavioral impairment. Alzheimers Dement. 2016;12(2):195–202. https://0-doi-org.brum.beds.ac.uk/10.1016/j.jalz.2015.05.017.

    Article  PubMed  Google Scholar 

  4. 4.

    Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015;350(mar02 7):h369. https://0-doi-org.brum.beds.ac.uk/10.1136/bmj.h369.

    Article  PubMed  PubMed Central  Google Scholar 

  5. 5.

    Petrovic M, Hurt C, Collins D, Burns A, Camus V, Liperoti R, et al. Clustering of behavioural and psychological symptoms in dementia (BPSD): a European Alzheimer’s disease consortium (EADC) study. Acta Clin Belg. 2007;62(6):426–32. https://0-doi-org.brum.beds.ac.uk/10.1179/acb.2007.062.

    CAS  Article  PubMed  Google Scholar 

  6. 6.

    Deborah Koder GEH. Staff’s views on managing symptoms of dementia in nursing home residents. Nurs Older People. 2014;26(10):31–6. https://0-doi-org.brum.beds.ac.uk/10.7748/nop.26.10.31.e638.

    Article  PubMed  Google Scholar 

  7. 7.

    van den Kieboom R, Snaphaan L, Mark R, Bongers I. The Trajectory of Caregiver Burden and Risk Factors in Dementia Progression: A Systematic Review. J Alzheimers Dis. 2020;77:1107–15.

    Article  Google Scholar 

  8. 8.

    Gulla C, Selbaek G, Flo E, Kjome R, Kirkevold Ø, Husebo BS. Multi-psychotropic drug prescription and the association to neuropsychiatric symptoms in three Norwegian nursing home cohorts between 2004 and 2011. BMC Geriatr. 2016;16(1):115. https://0-doi-org.brum.beds.ac.uk/10.1186/s12877-016-0287-1.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  9. 9.

    Maher AR, Maglione M, Bagley S, Suttorp M, Hu J-H, Ewing B, et al. Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis. JAMA. 2011;306(12):1359–69. https://0-doi-org.brum.beds.ac.uk/10.1001/jama.2011.1360.

    CAS  Article  PubMed  Google Scholar 

  10. 10.

    Bergh S, Selbæk G, Engedal K. Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial. BMJ. 2012;344(mar09 1):e1566. https://0-doi-org.brum.beds.ac.uk/10.1136/bmj.e1566.

    CAS  Article  PubMed  Google Scholar 

  11. 11.

    Helvik A-S, Høgseth LD, Bergh S, Šaltytė-Benth J, Kirkevold Ø, Selbæk G. A 36-month follow-up of decline in activities of daily living in individuals receiving domiciliary care. BMC Geriatr. 2015;15(1):47. https://0-doi-org.brum.beds.ac.uk/10.1186/s12877-015-0047-7.

    Article  PubMed  PubMed Central  Google Scholar 

  12. 12.

    Bierman EJM, Comijs HC, Gundy CM, Sonnenberg C, Jonker C, Beekman ATF. The effect of chronic benzodiazepine use on cognitive functioning in older persons: good, bad or indifferent? Int J Geriatr Psychiatry. 2007;22(12):1194–200. https://0-doi-org.brum.beds.ac.uk/10.1002/gps.1811.

    CAS  Article  PubMed  Google Scholar 

  13. 13.

    Gedde MH, Husebo BS, Mannseth J, Kjome RLS, Naik M, Berge LI. Less is more: the impact of Deprescribing psychotropic drugs on behavioral and psychological symptoms and daily functioning in nursing home patients. Results from the cluster-randomized controlled COSMOS trial. Am J Geriatr Psychiatry. 2021;29(3):304–15. https://0-doi-org.brum.beds.ac.uk/10.1016/j.jagp.2020.07.004.

    Article  PubMed  Google Scholar 

  14. 14.

    Abraha I, Rimland JM, Trotta FM, Dell’Aquila G, Cruz-Jentoft A, Petrovic M, et al. Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series. BMJ Open. 2017;7(3):e012759. https://0-doi-org.brum.beds.ac.uk/10.1136/bmjopen-2016-012759.

    Article  PubMed  PubMed Central  Google Scholar 

  15. 15.

    Lyketsos CG, Colenda CC, Beck C, Blank K, Doraiswamy MP, Kalunian DA, et al. Position statement of the American Association for Geriatric Psychiatry regarding principles of care for patients with dementia resulting from Alzheimer disease. Am J Geriatr Psychiatry. 2006;14(7):561–72. https://0-doi-org.brum.beds.ac.uk/10.1097/01.JGP.0000221334.65330.55.

    Article  PubMed  Google Scholar 

  16. 16.

    Seitz DP, Brisbin S, Herrmann N, Rapoport MJ, Wilson K, Gill SS, et al. Efficacy and feasibility of nonpharmacological interventions for neuropsychiatric symptoms of dementia in long term care: a systematic review. J Am Med Dir Assoc. 2012;13:503–6 e2.

    Article  Google Scholar 

  17. 17.

    Ng QX, Ho CYX, Koh SSH, Tan WC, Chan HW. Doll therapy for dementia sufferers: a systematic review. Complement Ther Clin Pract. 2017;26:42–6. https://0-doi-org.brum.beds.ac.uk/10.1016/j.ctcp.2016.11.007.

    Article  PubMed  Google Scholar 

  18. 18.

    Green L, Matos P, Murillo I, Neushotz L, Popeo D, Aloysi A, et al. Use of dolls as a therapeutic intervention: relationship to previous negative behaviors and pro re nata (prn) Haldol use among geropsychiatric inpatients. Arch Psychiatr Nurs. 2011;25(5):388–9. https://0-doi-org.brum.beds.ac.uk/10.1016/j.apnu.2011.05.003.

    Article  PubMed  Google Scholar 

  19. 19.

    Mitchell G, McCormack B, McCance T. Therapeutic use of dolls for people living with dementia: A critical review of the literature. Dementia. 2014;15(5):976–1001. https://0-doi-org.brum.beds.ac.uk/10.1177/1471301214548522.

    Article  PubMed  Google Scholar 

  20. 20.

    Cantarella A, Borella E, Faggian S, Navuzzi A, De Beni R. Using dolls for therapeutic purposes: a study on nursing home residents with severe dementia. Int J Geriatr Psychiatry. 2018;33(7):915–25. https://0-doi-org.brum.beds.ac.uk/10.1002/gps.4872.

    CAS  Article  PubMed  Google Scholar 

  21. 21.

    Pezzati R, Molteni V, Bani M, Settanta C, Di Maggio MG, Villa I, et al. Can doll therapy preserve or promote attachment in people with cognitive, behavioral, and emotional problems? A pilot study in institutionalized patients with dementia. Front Psychol. 2014;5:342. https://0-doi-org.brum.beds.ac.uk/10.3389/fpsyg.2014.00342.

    Article  PubMed  PubMed Central  Google Scholar 

  22. 22.

    Browne CJ, Shlosberg E. Attachment theory, ageing and dementia: a review of the literature. Aging Ment Health. 2006;10(2):134–42. https://0-doi-org.brum.beds.ac.uk/10.1080/13607860500312118.

    CAS  Article  PubMed  Google Scholar 

  23. 23.

    Miesen BML. Alzheimer’s disease, the phenomenon of parent fixation and bowlby’s attachment theory. Int J Geriatr Psychiatry. 1993;8(2):147–53. https://0-doi-org.brum.beds.ac.uk/10.1002/gps.930080207.

    Article  Google Scholar 

  24. 24.

    Bisiani L, Angus J. Doll therapy: a therapeutic means to meet past attachment needs and diminish behaviours of concern in a person living with dementia--a case study approach. Dementia (London). 2013;12(4):447–62. https://0-doi-org.brum.beds.ac.uk/10.1177/1471301211431362.

    Article  Google Scholar 

  25. 25.

    Bowlby J. The making and breaking of affectional bonds: I. Aetiology and psychopathology in the light of attachment theory. Br J Psychiatry. 1977;130(3):201–10. https://0-doi-org.brum.beds.ac.uk/10.1192/bjp.130.3.201.

    CAS  Article  PubMed  Google Scholar 

  26. 26.

    Stephens A, Cheston R, Gleeson K. An exploration into the relationships people with dementia have with physical objects: An ethnographic study. Dementia. 2012;12(6):697–712. https://0-doi-org.brum.beds.ac.uk/10.1177/1471301212442585.

    Article  PubMed  Google Scholar 

  27. 27.

    Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295–309. https://0-doi-org.brum.beds.ac.uk/10.7326/0003-4819-148-4-200802190-00008.

    Article  PubMed  Google Scholar 

  28. 28.

    Tamura T, Nakajima K, Nambu M, Nakamura K, Yonemitsu S, Itoh A, et al. Baby dolls as therapeutic tools for severe dementia patients. Gerontechnology. 2001;1(2):111–8. https://0-doi-org.brum.beds.ac.uk/10.4017/gt.2001.01.02.004.00.

    Article  Google Scholar 

  29. 29.

    Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014;6(1):103–9. https://0-doi-org.brum.beds.ac.uk/10.4055/cios.2014.6.1.103.

    Article  PubMed  PubMed Central  Google Scholar 

  30. 30.

    Efficacy of Doll thErapy compared with standard treatment in the control of behavioral and psychologic Symptoms and CaRegIver Burden in dEmentia: DESCRIBE a randomized, controlled study - eSciPub Journals. https://escipub.com/ijoar-2021-02-1905/. Accessed 10 May 2021.

  31. 31.

    Cohen-Mansfield J, Marx MS, Dakheel-Ali M, Regier NG, Thein K. Can persons with dementia be engaged with stimuli? Am J Geriatr Psychiatry. 2010;18(4):351–62. https://0-doi-org.brum.beds.ac.uk/10.1097/JGP.0b013e3181c531fd.

    Article  PubMed  PubMed Central  Google Scholar 

  32. 32.

    Braden BA, Gaspar PM. Implementation of a baby doll therapy protocol for people with dementia: innovative practice. Dementia (London). 2015;14(5):696–706. https://0-doi-org.brum.beds.ac.uk/10.1177/1471301214561532.

    Article  Google Scholar 

  33. 33.

    Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The neuropsychiatric inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994;44(12):2308–14. https://0-doi-org.brum.beds.ac.uk/10.1212/WNL.44.12.2308.

    CAS  Article  PubMed  Google Scholar 

  34. 34.

    Wing L, Leekam SR, Libby SJ, Gould J, Larcombe M. The diagnostic interview for social and communication disorders: background, inter-rater reliability and clinical use. J Child Psychol Psychiatry. 2002;43(3):307–25. https://0-doi-org.brum.beds.ac.uk/10.1111/1469-7610.00023.

    Article  PubMed  Google Scholar 

  35. 35.

    Fenzio F. Manuale di consulenza pedagogica in ambito familiare, giuridico e scolastico 2017. Youcanprint.

    Google Scholar 

  36. 36.

    Cummings JL. The neuropsychiatric inventory: assessing psychopathology in dementia patients. Neurology. 1997;48(5 Suppl 6):10S–6S. https://0-doi-org.brum.beds.ac.uk/10.1212/WNL.48.5_Suppl_6.10S.

    Article  Google Scholar 

  37. 37.

    Swinnen N, Vandenbulcke M, de Bruin ED, Akkerman R, Stubbs B, Firth J, et al. The efficacy of exergaming in people with major neurocognitive disorder residing in long-term care facilities: a pilot randomized controlled trial. Alzheimers Res Ther. 2021;13(1):70. https://0-doi-org.brum.beds.ac.uk/10.1186/s13195-021-00806-7.

    Article  PubMed  PubMed Central  Google Scholar 

  38. 38.

    Olin K. Perceived caregiver burden as a function of differential coping strategies: (410202005–016); 1995. https://0-doi-org.brum.beds.ac.uk/10.1037/e410202005-016.

    Book  Google Scholar 

  39. 39.

    Inouye SK. Clarifying confusion: the confusion assessment method: a new method for detection of delirium. Ann Intern Med. 1990;113(12):941–8. https://0-doi-org.brum.beds.ac.uk/10.7326/0003-4819-113-12-941.

    CAS  Article  PubMed  Google Scholar 

  40. 40.

    Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients†. J Am Geriatr Soc. 1975;23(10):433–41. https://0-doi-org.brum.beds.ac.uk/10.1111/j.1532-5415.1975.tb00927.x.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  41. 41.

    Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970;10(1 Part 1):20–30. https://0-doi-org.brum.beds.ac.uk/10.1093/geront/10.1_Part_1.20.

    CAS  Article  PubMed  Google Scholar 

  42. 42.

    Faul F, Erdfelder E, Lang A-G, Buchner A. G*power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91. https://0-doi-org.brum.beds.ac.uk/10.3758/BF03193146.

    Article  Google Scholar 

  43. 43.

    Salari SM. Intergenerational partnerships in adult day centers: importance of age-appropriate environments and behaviors. Gerontologist. 2002;42(3):321–33. https://0-doi-org.brum.beds.ac.uk/10.1093/geront/42.3.321.

    Article  PubMed  Google Scholar 

  44. 44.

    James IA, Mackenzie L, Mukaetova-Ladinska E. Doll use in care homes for people with dementia. Int J Geriatr Psychiatry. 2006;21(11):1093–8. https://0-doi-org.brum.beds.ac.uk/10.1002/gps.1612.

    Article  PubMed  Google Scholar 

  45. 45.

    Balzotti A, Filograsso M, Altamura C, Fairfield B, Bellomo A, Daddato F, et al. Comparison of the efficacy of gesture-verbal treatment and doll therapy for managing neuropsychiatric symptoms in older patients with dementia. Int J Geriatr Psychiatry. 2019;34(9):1308–15. https://0-doi-org.brum.beds.ac.uk/10.1002/gps.4961.

    Article  PubMed  Google Scholar 

  46. 46.

    Moyle W, Murfield J, Jones C, Beattie E, Draper B, Ownsworth T. Can lifelike baby dolls reduce symptoms of anxiety, agitation, or aggression for people with dementia in long-term care? Findings from a pilot randomised controlled trial. Aging Ment Health. 2019;23(10):1442–50. https://0-doi-org.brum.beds.ac.uk/10.1080/13607863.2018.1498447.

    Article  PubMed  Google Scholar 

  47. 47.

    Yilmaz CK, Aşiret GD. The Effect of Doll Therapy on Agitation and Cognitive State in Institutionalized Patients With Moderate-to-Severe Dementia: A Randomized Controlled Study. J Geriatr Psychiatry Neurol. 2020;34:891988720933353.

    Google Scholar 

  48. 48.

    Cohen-Mansfield J, Thein K, Dakheel-Ali M, Regier NG, Marx MS. The value of social attributes of stimuli for promoting engagement in persons with dementia. J Nerv Ment Dis. 2010;198(8):586–92. https://0-doi-org.brum.beds.ac.uk/10.1097/NMD.0b013e3181e9dc76.

    Article  PubMed  PubMed Central  Google Scholar 

  49. 49.

    Ellingford J, James I, Mackenzie L, Marsland L. Using dolls to alter behaviour in patients with dementia. Nurs Times. 2007;103:36–7.

    Google Scholar 

  50. 50.

    Hirakawa Y, Chiang C, Aoyama A. A qualitative study on barriers to achieving high-quality, community-based integrated dementia care. J Rural Med. 2017;12(1):28–32. https://0-doi-org.brum.beds.ac.uk/10.2185/jrm.2927.

    Article  PubMed  PubMed Central  Google Scholar 

  51. 51.

    Davis DHJ, Skelly DT, Murray C, Hennessy E, Bowen J, Norton S, et al. Worsening cognitive impairment and neurodegenerative pathology progressively increase risk for delirium. Am J Geriatr Psychiatry. 2015;23(4):403–15. https://0-doi-org.brum.beds.ac.uk/10.1016/j.jagp.2014.08.005.

    Article  PubMed  PubMed Central  Google Scholar 

  52. 52.

    Witlox J, Eurelings LSM, de Jonghe JFM, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010;304(4):443–51. https://0-doi-org.brum.beds.ac.uk/10.1001/jama.2010.1013.

    CAS  Article  PubMed  Google Scholar 

  53. 53.

    Hipp DM, Ely EW. Pharmacological and nonpharmacological Management of Delirium in critically ill patients. Neurotherapeutics. 2012;9(1):158–75. https://0-doi-org.brum.beds.ac.uk/10.1007/s13311-011-0102-9.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  54. 54.

    Inouye SK, Westendorp RGJ, Saczynski JS. Delirium in elderly people. Lancet. 2014;383(9920):911–22. https://0-doi-org.brum.beds.ac.uk/10.1016/S0140-6736(13)60688-1.

    Article  PubMed  Google Scholar 

  55. 55.

    Johnson K, Fleury J, McClain D. Music intervention to prevent delirium among older patients admitted to a trauma intensive care unit and a trauma orthopaedic unit. Intensive Crit Care Nurs. 2018;47:7–14. https://0-doi-org.brum.beds.ac.uk/10.1016/j.iccn.2018.03.007.

    Article  PubMed  Google Scholar 

  56. 56.

    Inouye SK, Baker DI, Fugal P, Bradley EH. HELP dissemination project. Dissemination of the hospital elder life program: implementation, adaptation, and successes. J Am Geriatr Soc. 2006;54(10):1492–9. https://0-doi-org.brum.beds.ac.uk/10.1111/j.1532-5415.2006.00869.x.

    Article  PubMed  Google Scholar 

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Acknowledgements

Valeria Suriano (nurse) and Alice Barberis (nurse) recruited nursing homes residents.

Funding

The cultural association Leadership Experience Opportunity (LEO) district 108 donated the dolls.

Author information

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Authors

Contributions

FS enrolled the patients, participate in the study design and data analyses, MM participate in the study design and data analyses, PD designed the study, analyses the data and wrote the first draft of the manuscript. All authors reviewed the manuscript. The author(s) read and approved the final manuscript.

Corresponding author

Correspondence to Patrizia D’Amelio.

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Ethics approval and consent to participate

This research has been performed in accordance with the Declaration of Helsinki and have been approved by the Ethical Committee “Comitato Etico Interaziendale AO Città della Salute e della Scienza di Torino” approved the study (Ref. no. CE il 04/10/2018 protocol number 0098548). Written informed consent was obtained from all the participants, in patients with impaired capacity to consent a proxy consent was obtained.

Consent for publication

Not Applicable.

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The authors declare that they have no competing interests.

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Santagata, F., Massaia, M. & D’Amelio, P. The doll therapy as a first line treatment for behavioral and psychologic symptoms of dementia in nursing homes residents: a randomized, controlled study. BMC Geriatr 21, 545 (2021). https://0-doi-org.brum.beds.ac.uk/10.1186/s12877-021-02496-0

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Keywords

  • Dementia
  • Behavioral and psychologic symptoms of dementia
  • Nursing home
  • Doll therapy
  • Delirium
  • Non-pharmacological approach