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Doll Therapy on Patients With Moderate and Severe Dementia

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Doll therapy
Routine nursing care
Sponsored by
Aksaray University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Dementia, Agitation, Cognitive status, Doll therapy

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cemile KÜTMEÇ YILMAZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Doll therapy

Routine nursing care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Standardized Mini Mental Test
cognitive status
Cohen-Mansfield Agitation Inventory
Cognitive and agitation status

Secondary Outcome Measures

Full Information

First Posted
August 1, 2019
Last Updated
August 10, 2021
Sponsor
Aksaray University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04120103
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Agitation, Cognitive status, Doll therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doll therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine nursing care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Doll therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine nursing care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Standardized Mini Mental Test
Description
cognitive status
Time Frame
2 months after the beginning intervention.
Title
Cohen-Mansfield Agitation Inventory
Description
Cognitive and agitation status
Time Frame
2 months after the beginning intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemile KÜTMEÇ YILMAZ, Dr
Organizational Affiliation
Aksaray University, Faculty of Health Science, Nursing Department, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cemile KÜTMEÇ YILMAZ
City
Merkez
State/Province
Aksaray
ZIP/Postal Code
68100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32552299
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.
Results Reference
derived

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Doll Therapy on Patients With Moderate and Severe Dementia

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