Clinical trial NCT04120103: Doll Therapy on Patients With Moderate and Severe Dementia
Official title: Effect of Doll Therapy on the Cognitive States and Agitation Levels of Patients With Moderate and Severe Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Agitation
Cognitive status
Doll therapy
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 29
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Doll therapy is one of the non-pharmacological methods that can be practiced in managing the symptoms of dementia patients. Nurses can practice doll therapy independently, and literature reports that it has positive effects on the behaviors, moods, emotions, cognitive states and social life of patients with moderate and severe dementia. Our country had no study that investigated the effect of doll therapy in managing the cognitive and behavioral symptoms of dementia patients. This project is a randomized controlled trial that aims to investigate the effect of Doll therapy on the cognitive states and agitation levels of patients with moderate and severe dementia.

Detailed description: Dementia is a progressive neurodegenerative disease increasing in prevalence due to the aging population that grows in parallel with the increased life expectancy at birth in recent years. It is characterized with a progressive deterioration in cognitive abilities and memory. Due to the increasing losses in cognitive and physical functions, people with dementia become in need of nursing over time. Agitation is the most common behavioral symptom.

Agitation is defined as improper verbal, vocal and motor activity that are not purposeful and are not caused by confusion. Verbal and physical aggression, restlessness, aimless wandering, profanity, self-harm, continuous and repetitive questioning behavior emerges.Agitation should be managed with reliable and tolerable, effective methods in order to affect the quality of life of both the patient and the caregiver negatively.

Doll therapy is one of the non-pharmacological methods that can be practiced in managing the symptoms of dementia patients. Nurses can practice doll therapy independently, and literature reports that it has positive effects on the behaviors, moods, emotions, cognitive states and social life of patients with moderate and severe dementia.Our country had no study that investigated the effect of doll therapy in managing the cognitive and behavioral symptoms of dementia patients. This study is a randomized controlled trial that aims to investigate the effect of Doll therapy on the cognitive states and agitation levels of patients with moderate and severe dementia.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with moderate to severe dementia (those with a SMMT score of 17 or less)
* Having dexterity to hold or caress a baby
* No problem with communication obstruction
* Dementia patients who agree to participate in the study

Exclusion Criteria:

* Mild stage dementia,
* Diagnosed with neurological or psychiatric diseases other than dementia, not accepting the baby despite two attempts,
* Rarely agitated dementia patients with baby dolls

Primary outcomes:
measure: Standardized Mini Mental Test
timeFrame: 2 months after the beginning intervention.
measure: Cohen-Mansfield Agitation Inventory
timeFrame: 2 months after the beginning intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Cemile KÜTMEÇ YILMAZ
state: Aksaray
Study officials:
affiliation: Aksaray University, Faculty of Health Science, Nursing Department, Turkey
name: Cemile KÜTMEÇ YILMAZ, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yilmaz CK, Asiret 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. 2021 Sep;34(5):370-377. doi: 10.1177/0891988720933353. Epub 2020 Jun 17.