Evidence map›Paper›PMID 32014029›Full record

ArticleTrials2020

Doll therapy intervention for women with dementia living in nursing homes: a randomized single-blind controlled trial protocol.

Roberta Vaccaro, Roberta Ballabio, Valentina Molteni, Laura Ceppi, Benedetta Ferrari, Marco Cantù, Daniele Zaccaria, Carla Vandoni, Rita Bianca Ardito, Mauro Adenzato and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03224143 (Doll Therapy Efficacy for People With Dementia Living in Nursing Homes), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

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

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

2 · The registry

The trial behind it

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

NCT03224143 naunknown statusnot on this map

Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial

TypeinterventionalSponsorUniversity of Applied Sciences and Arts of Southern SwitzerlandRan2017 to 2020Enrolled128ConditionsDementiaArmsDoll Therapy Intervention, active control group (SI)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
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  5. Article
4 · The record

Corrections and comments

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

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 2 countries.

Roberta VaccaroGolgi Cenci Foundation, Corso San Martino 10, 20081, Abbiategrasso, Italy. r.vaccaro@golgicenci.it.ORCID http://orcid.org/0000-0003-1124-6105
Roberta BallabioDipartimento di Economia Aziendale e Socio Sanitaria (SUPSI), Centro Competenza Anziani, Manno, Switzerland.
Valentina MolteniDipartimento di Economia Aziendale e Socio Sanitaria (SUPSI), Centro Competenza Anziani, Manno, Switzerland.
Laura CeppiSchool of Cognitive Therapy, Como, Italy.
Benedetta FerrariDipartimento di Medicina di Laboratorio EOLAB, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
Marco CantùDipartimento di Medicina di Laboratorio EOLAB, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
Daniele ZaccariaGolgi Cenci Foundation, Corso San Martino 10, 20081, Abbiategrasso, Italy.
Carla VandoniSchool of Cognitive Therapy, Como, Italy.
Rita Bianca ArditoDepartment of Neuroscience 'Rita Levi Montalcini', University of Turin, Turin, Italy.
Mauro AdenzatoDepartment of Psychology, University of Turin, Turin, Italy.
Barbara PolettiDepartment of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS, Milan, Italy.
Antonio GuaitaGolgi Cenci Foundation, Corso San Martino 10, 20081, Abbiategrasso, Italy.
Rita PezzatiDipartimento di Economia Aziendale e Socio Sanitaria (SUPSI), Centro Competenza Anziani, Manno, Switzerland.
Fondazione Golgi Cenci · ITUniversity of Applied Sciences and Arts of Southern Switzerland · CHEnte Ospedaliero Cantonale · CHUniversity of Turin · ITIRCCS Istituto Auxologico Italiano · IT

Funding

Alzheimer Switzerland Association section of Canton Ticino 2CSRD VA 1Fidinam Foundation 3FOUNDATION FOR THE STUDY OF NEURODEGENERATIVE DISEASES OF ADULTS AND THE ELDERLY 4Pica Alfieri Foundation 6Riziero Rezzonico Foundation 5School of Cognitive Psychotherapy 7
6 · The paper itself

Abstract

backgroundDoll therapy is a non-pharmacological intervention for people with dementia aimed to reduce distressing behaviours. Reliable results on the efficacy of Doll therapy for people with dementia are needed. The concept of attachment theorised by Bowlby has been proposed to explain the Doll therapy process, but it has not been proven to influence the response to doll presentation. METHODS/

designThis single-blind, randomised controlled trial will involve people with dementia living in nursing homes of the Canton Ticino (Switzerland). Participants will be randomised to one of two interventions: Doll Therapy Intervention or Sham Intervention with a non-anthropomorphic object, using a 1:1 allocation ratio. The two interventions will consist of 30 daily sessions lasting an hour at most, led by a trained nurse for an hour at most. We will enrol 64 participants per group, according to power analysis using an estimated medium effect size (f = 0.25), an alpha level of 0.05, and a power of 0.8. The primary goal is to test the efficacy of the Doll Therapy Intervention versus the Sham Intervention as the net change in the following measures from baseline to 30 days (blinded outcomes): the Neuropsychiatric Inventory-Nursing Home administered by a trained psychologist blinded to group assignment, the professional caregivers' perceived stress scale of the Neuropsychiatric Inventory-Nursing Home, patients' physiological indices of stress (salivary cortisol, blood pressure and heart rate) and interactive behaviours. The secondary goal is to assess the relationship between attachment styles of people with dementia (detected by means of the Adult Attachment Interview to the patients' offspring) and their caregiving behaviours shown during the Doll Therapy Intervention. DISCUSSION: This is the first single-blind, randomised controlled trial on the efficacy of Doll therapy for dementia and an explanatory model of the response of people with dementia to doll presentation.

trial registrationClinicalTrials.gov, ID: NCT03224143. Retrospectively registered on 21 July 2017.

Indexed as

Nursing HomesCaregiversDementiaFemaleHumansNursesPlay TherapyPsychologyRandomized Controlled Trials as TopicSingle-Blind MethodSwitzerlandTreatment OutcomeAttachmentBehaviourCaregiversDementiaDoll therapy

Identifiers

PMID32014029
PMCPMC6998291
OpenAlexW3004849044

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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