Doll Therapy for Agitated Elderly Dementia People

NCT ID: NCT06578819

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-05-31

Brief Summary

This study is designed to determine the effect of doll therapy on the levels of agitation, nutrition, and daily living activities in elderly patients with dementia and agitation.

Detailed Description

Elderly patients with agitation and dementia incur significant costs for healthcare services. Additionally, it is known that agitation can impose a burden on caregivers and has the potential to cause harm to the individual and those around them. This study is planned to determine the effect of doll therapy on the levels of agitation, nutrition, and daily living activities in elderly patients with dementia and agitation.

Conditions

Dementia; Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

experimental group (moderate dementia)

Prior to the start of the study, the MMSE was administered to identify patients in the experimental group with severe and moderate dementia. Patients who scored between 0 and 17 on the MMSE were classified as having severe dementia, while those who scored between 18 and 23 were classified as having moderate dementia and included in the study. Before the intervention began, the vital signs of elderly patients with dementia were recorded and documented using the Structured Patient Information Form.

Toy doll therapy was administered by the same researcher to elderly dementia patients who scored 35 or higher on the long form of the CMAI. In accordance with the principles of toy doll therapy as outlined in the literature, the intervention was conducted four days per week over a total period of 12 weeks for agitated elderly patients with dementia.

Three standardized assessment tools were administered to both the moderate and severe dementia groups at three time point

Group Type: EXPERIMENTAL

doll therapy

Intervention Type: BEHAVIORAL

Doll therapy applied to the experimental group 4 days a week.

control group (moderate dementia)

Before the study commenced, the MMSE was administered to identify patients in the control group with moderate and severe dementia. Patients scoring between 0 and 17 were classified as having severe dementia, while those scoring between 18 and 23 were classified as having moderate dementia and included in the study. Prior to the start of the intervention, the vital signs of elderly patients with dementia were recorded and documented using the Structured Patient Information Form.

Elderly dementia patients who scored above 35 on the long form of the CMAI were included in the control group. No intervention was administered to either subgroup (moderate and severe dementia patients) in the control group. These patients continued to receive their routine medical care and treatment.

Patients in the control group were assessed using the CMAI, the EdFED, and the Katz ADL at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12).

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group (severe dementia)

Prior to the start of the study, the MMSE was administered to identify patients in the experimental group with severe and moderate dementia. Patients who scored between 0 and 17 on the MMSE were classified as having severe dementia, while those who scored between 18 and 23 were classified as having moderate dementia and included in the study. Before the intervention began, the vital signs of elderly patients with dementia were recorded and documented using the Structured Patient Information Form.

Toy doll therapy was administered by the same researcher to elderly dementia patients who scored 35 or higher on the long form of the CMAI. In accordance with the principles of toy doll therapy as outlined in the literature, the intervention was conducted four days per week over a total period of 12 weeks for agitated elderly patients with dementia.

Three standardized assessment tools were administered to both the moderate and severe dementia groups at three time point

Group Type: EXPERIMENTAL

doll therapy

Intervention Type: BEHAVIORAL

Doll therapy applied to the experimental group 4 days a week.

control group (severe dementia)

Before the study commenced, the MMSE was administered to identify patients in the control group with moderate and severe dementia. Patients scoring between 0 and 17 were classified as having severe dementia, while those scoring between 18 and 23 were classified as having moderate dementia and included in the study. Prior to the start of the intervention, the vital signs of elderly patients with dementia were recorded and documented using the Structured Patient Information Form.

Elderly dementia patients who scored above 35 on the long form of the CMAI were included in the control group. No intervention was administered to either subgroup (moderate and severe dementia patients) in the control group. These patients continued to receive their routine medical care and treatment.

Patients in the control group were assessed using the CMAI, the EdFED, and the Katz ADL at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

doll therapy

Doll therapy applied to the experimental group 4 days a week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Aged 65 years or older, met the DSM-IV diagnostic criteria for dementia, clinical diagnosis of Alzheimer's disease, diagnosis of dementia (moderate or severe) confirmed by a neurologist, must be able to swallow tablets, had sufficient hand motor skills to hold and care for a doll, had adequate visual acuity to recognize the doll, had no significant communication impairments, were personally willing to participate in the study, had the consent of their legal guardians or family members for participation in the study. Exhibiting agitation, defined as a score of 35 or higher on the long form of the CMAI.

Exclusion Criteria

Participants were excluded from the study if they had a diagnosis of mild dementia, were experiencing an acute exacerbation of a systemic illness, or had a diagnosed psychological disorder, Insulin dependent diabetes and thyroid disease. Additionally, elderly individuals who experienced difficulty accepting and forming a relationship with the doll after two attempts were excluded from the study. Those who initially accepted the doll but later abandoned it were also excluded. Lastly, participants who reported that the doll triggered negative associations or adverse emotional responses were excluded.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

AYNUR CİN

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AYNUR CIN, DR

Role: STUDY_DIRECTOR

Gümüşhane Universıty

Locations

Kelkit State Hospital

Kelkit, Gümüşhane Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

25/10/2023 date and 2023/5

Identifier Type: -

Identifier Source: org_study_id