Table 1.

Characteristics of the studies included in the systematic review.

Author	Type of Study and Participants				Characteristics of the Intervention of Doll Therapy					Results
	n	Study	Age (Yrs)	Sex	Inclusion Criteria	Emplacement	Experimental Group	Control Group	Outcome Measure
Moyle, 2018 [29]	35	RCT	<65 years	Female	<65 years, dementia diagnosis; documented history (in last four weeks) of anxiety, agitation, or aggressiveness.	Residents were recruited from five LTC facilities located within a 60 km radius of the Brisbane Central Business District (Queensland, Australia)	Doll Therapy	Usual treatment	Mini Mental CMAI-SF; OERS	Clinically significant improvements in the well-being of residents in comparison with the usual care, but there were no improvements in anxiety, agitation, and aggressiveness.
Balzoti 2018 [31]	30	Non-randomized clinical trial	<65 years	25 Females 10 Males	Severe to low cognitive impairment, behavioral disorders, <65 years, dementia.	Residenza Sociosanitaria Assistenziale per Anziani “Storelli” in Bisceglie (Italia)	1. Doll therapy 2. Gestural-verbal treatment	No intervention	NPI-Q	Doll therapy was effective for the reduction of agitated and irritable behaviors. No changes in apathy were found.
Cantarella, 2018 [28]	32	RCT	<70 years	26 Females 6 Males	Punctuation of ≥5 in the Short Portable Mental Status Questionnaire; <70 years; dementia diagnosis, post-traumatic stress disorder according to doctors; no participation in other non-pharmacological interventions before or during the study; without severe sensorial or perceptive deficiencies or ongoing mourning; and the capacity of understanding easy messages and producing sentences.	Residential facilities	Doll Therapy	Hand-warmer	SPMSQ EBS	Significative reduction in post-traumatic stress disorder, relief of negative feelings, fulfilling of attachment needs, and the reduction of the feeling of loneliness. Several aspects that influence food intake, such as anguish, improved but not enough to improve the eating behavior.
Yilmaz, 2020 [30]	29	RCT	82–89 years	15 Females 14 Males	Moderate-severe dementia, motor abilities needed to hold and caress a doll, adequate visual and auditive functions, and ability to communicate in Turkish.	A. KadirU¨ c¸yıldız, elder facility	Doll Therapy	No intervention	SMMSE CMAI NPI-Q	Statistically significant improvements in agitation and behavior problems. Cognition did not improve.
Shin, 2015 [20]	62	pre-post	82.4 years	86.3% Females 74.5% Males	Slight-severe cognitive impairment, three months residing in the nursing home.	Korea nursing home	Doll Therapy	-	SMMSE QUALID	Statistically significant decrease in the use of swear words, shouts, aggressive episodes, and less obsessive behaviors. Erratic wandering episodes were reduced as well. There were found positive changes in moods and physical appearance, a decrease of depression, and an increment of the interactions with other individuals, but without significant differences.
Mackenzie, 2006 [33]	14	Pilot study	75–94 years	12 Females 2 Males	-	Nursing home	Doll Therapy	-	Ad hoc questionnaire	Increase in social interaction. The participants seemed to be happier and less agitated. They were also more receptive towards personal care activities; erratic wandering episodes were reduced.
Cohen-Mansfield, 2014 [32]	93	Exploratory study	85.9 years	73% Females	Three months residing at a nursing home, behavior disorders, <60, dementia diagnosis.	Maryland nursing home	Doll Therapy	-	MMSE CAR LMBS	There was a rejection of Doll Therapy; it is associated with a low social level. In spite of this, it was one of the most used therapies and obtained a relatively high rate for the impact on the behavioral symptoms.

CAR: Change Assessment Rating; CMAI-SF: Cohen-Mansfield Agitation Inventory-Short Form; EBS: Eating Behavior Scale; LMBS: Lawton’s Modified Behavior Stream; LTC: Long term care; MMSE: Mini-Mental Status Examination; NPI-Q: Neuropsychiatric Inventory Questionnaire; OERS: Observed Emotion Rating Scale; QUALID: quality of life in late-stage dementia; SMMSE: Standardized Mini-Mental State Examination; SPMSQ: short portable mental status questionnaire; RCT: randomized controlled trial.