Doll Therapy on Patients With Moderate and Severe Dementia

Sponsor
Aksaray University Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04120103
Collaborator
(none)
29
1
2
6.7
4.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Doll therapy
  • Other: Routine nursing care
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Doll Therapy on the Cognitive States and Agitation Levels of Patients With Moderate and Severe Dementia
Actual Study Start Date :
Apr 8, 2019
Actual Primary Completion Date :
Oct 30, 2019
Actual Study Completion Date :
Oct 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Doll therapy

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
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.

Active Comparator: 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. 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
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.

Outcome Measures

Primary Outcome Measures

  1. Standardized Mini Mental Test [2 months after the beginning intervention.]

    cognitive status

  2. Cohen-Mansfield Agitation Inventory [2 months after the beginning intervention]

    Cognitive and agitation status

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cemile KÜTMEÇ YILMAZ Merkez Aksaray Turkey 68100

Sponsors and Collaborators

  • Aksaray University Training and Research Hospital

Investigators

  • Principal Investigator: Cemile KÜTMEÇ YILMAZ, Dr, Aksaray University, Faculty of Health Science, Nursing Department, Turkey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cemile KÜTMEÇ YILMAZ, Principal Investigator, Aksaray University Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04120103
Other Study ID Numbers:
  • 2017/81
First Posted:
Oct 9, 2019
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cemile KÜTMEÇ YILMAZ, Principal Investigator, Aksaray University Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021