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

Abstract

Background: Doll 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/design: This 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 registration: ClinicalTrials.gov, ID: NCT03224143. Retrospectively registered on

The Effect of Doll Therapy on Agitation and Cognitive State in Institutionalized Patients With Moderate-to-Severe Dementia: A Randomized Controlled Study

“…In addition, it has been suggested that such a surrogate for a real infant can revive the positive emotions of the parent-child relationship, 19 and that the lullabies, feeding, holding, and singing activities carried out for the sake of the "baby" can increase self-esteem. 24,25 Furthermore, it has been reported that doll therapy creates a therapeutic bond, 9,26 promotes feelings of calmness and competence, provides sensory stimulation, and contributes to the development of communication with the patient's external environment and caregivers. 18,11,24,25 Studies in the literature have demonstrated similar results, 9,11,16,17,27 and it has been reported that doll therapy has conferred positive effects on behavioral, psychological, emotional, and cognitive problems, as well as the social lives of institutionalized patients with severe dementia.…”

Doll Therapy Intervention Reduces Challenging Behaviours of Women with Dementia Living in Nursing Homes: Results from a Randomized Single-Blind Controlled Trial

“…DTI offers relevant advantages in terms of costs-effectiveness: unlike other nonpharmacological treatments (e.g., pets, music, or art therapy), it does not necessarily require the presence of a skilled therapist but can be carried out within 24 h by nursing home staff (nurses, assistants) if they are properly trained and supervised. As previously described [ 7 , 29 ], PWD take care of the dolls even in the absence of a professional caregiver.…”

“…The intervention procedure has been described in detail elsewhere [ 29 ]. Participants attended daily DTI or SI sessions for a maximum of one hour, led by a trained professional caregiver.…”

“…We expected an increase in the interaction with the object (doll), as the exploration and caregiving behaviours during the object presentation were recorded at the first and 30th session by a trained psychologist who filled an observational grid developed for the aims of the present study [ 29 ]. It includes four kinds of behavioural responses: i.e., i. object presentation; ii.…”