Doll Therapy on Patients With Moderate and Severe Dementia

Dementia Clinical Trial

Official title:

Effect of Doll Therapy on the Cognitive States and Agitation Levels of Patients With Moderate and Severe Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120103
• Other study ID #: 2017/81
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: August 2021
• Source: Aksaray University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Doll therapy
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.

Other:
• Routine nursing care
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.

Locations

Country	Name	City	State
Turkey	Cemile KÜTMEÇ YILMAZ	Merkez	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized Mini Mental Test	cognitive status	2 months after the beginning intervention.
Primary	Cohen-Mansfield Agitation Inventory	Cognitive and agitation status	2 months after the beginning intervention