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NCT Number: NCT04120103

Doll Therapy on Patients With Moderate and Severe Dementia

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.

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Key information

Conditions

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

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cemile KÜTMEÇ YILMAZ

Merkez, Aksaray, 68100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Standardized Mini Mental Test

    Time frame: 2 months after the beginning intervention.

    cognitive status

  2. Cohen-Mansfield Agitation Inventory

    Time frame: 2 months after the beginning intervention

    Cognitive and agitation status

Sponsors and collaborators

Lead sponsor

Aksaray University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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