Doll Therapy on Patients With Moderate and Severe Dementia

NCT04120103 | Completed

• 1 other identifier: 2017/81
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Dementia; Agitation; Cognitive status; Doll therapy

Outcome Measures

Primary Outcomes (2)

• Standardized Mini Mental Test

  cognitive status

  2 months after the beginning intervention.

• Cohen-Mansfield Agitation Inventory

  Cognitive and agitation status

  2 months after the beginning intervention

Study Arms (2)

Doll therapy

EXPERIMENTAL

Experimental: Doll Therapy Intervention A total of 30 patients were included in the study. All patients that meet the study inclusion criteria will be included in the study The patients in the intervention group will have Doll therapy for 60 days and weekly patient visits. The study will be started with control group patients. At the beginning of the study and after 60 days, "Introductory Information Form", Mini Standard Mini Mental Test "and" Cohen-Mansfield Agitation Inventory "will be applied to patients in intervention and control groups for data collection. Dementia patients will be given a baby, patients will be followed for two months. There will be monitoring once a week.

Behavioral: Doll therapy

Routine nursing care

ACTIVE COMPARATOR

The nursing care provided by the institution was applied to the dementia patients in the routine nursing care group. Routine nursing care group interventions in the institution; Monitoring of life signs, application of drug treatments, participation in social activities such as listening to music, reading prayer, initiatives such as assisting patients in performing daily living activities. There was no intervention other than routine care. The patients were followed up for two months.The patients were followed up for two months.Data collection forms were applied at the beginning, first and second months of the study.

Other: Routine nursing care

Interventions

Doll therapy BEHAVIORAL

The patient will then be given the doll to be used in the research by the caregiver and the researcher. Intervention group (accepting the baby) will be evaluated in terms of interaction with the baby, communication with employees and other patients and participation in daily life activities for 60 days. In addition, the agitation symptoms of the patients during the 60 days they spend with the baby will be evaluated by CMAI and cognitive level by MMSE.

Doll therapy

Routine nursing care OTHER

The nursing care provided by the institution was applied to the dementia patients in the routine nursing care group. Routine nursing care group interventions in the institution; Monitoring of life signs, application of drug treatments, participation in social activities such as listening to music, reading prayer, initiatives such as assisting patients in performing daily living activities.

Routine nursing care

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Cemile KÜTMEÇ YILMAZ

Merkez, Aksaray, 68100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32552299 DERIVED

MeSH Terms

Conditions

Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Cemile KÜTMEÇ YILMAZ, Dr

  Aksaray University, Faculty of Health Science, Nursing Department, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: October 9, 2019
• Study Start: April 8, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)