Dementia, Agitation
Conditions
Keywords
dementia, doll therapy, nursing, daily activity, nutrition
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.
Interventions
BEHAVIORALdoll therapy
Doll therapy applied to the experimental group 4 days a week.
Sponsors
Karadeniz Technical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the inherent nature of doll therapy, blinding of participants and the researcher administering the intervention was not feasible. Participants were aware if they were receiving doll therapy, and the researcher delivering the therapy was also aware of the assigned group. However, to minimize detection bias, all outcome assessors who administered the CMAI, EdFED, and Katz ADL were rigorously blinded to group allocation. These assessors were specifically instructed not to inquire about or discuss the participants' treatment assignments.
Intervention model description
pre-test and post-test case control
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Edinburgh feeding evaluation in dementia (EdFED) scale (Nutrition) | 12 week | One standardized assessment tool administered to both the moderate and severe dementia groups at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12). These tool included the EdFED. The scale consists of 11 items and can be administered in less than five minutes. The first 10 items address feeding behaviors during meals; each item is scored based on the frequency of occurrence. If the behavior does not occur during meals, it is scored as never (0 points), if it occurs 2-3 times a week it is scored as sometimes (1 point), and if it occurs more than 4 times a week, it is scored as often (2 points). There is no cutoff score or reverse scoring in the scale. The total score obtained from the first 10 items ranges from 0 to 20, with a score of 20 indicating the most severe condition. The total score can be used to track changes in the patient's nutritional status. The level of support the patient requires is determined by item 11. |
| Cohen-Mansfield Agitation Inventory (Agitation) | 12 week | One standardized assessment tool administered to both the moderate and severe dementia groups at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12). These tool included the CMAI. The CMAI uses a Likert scale, where each item is scored from 1 never to 7 several times per hour. The total score is calculated based on a maximum of 32 items, with a possible total score range from 29 to 181. |
| Katz Daily Life Activities Scale (Daily activities) | 12 week | One standardized assessment tool administered to both the moderate and severe dementia groups at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12). These tool included the Katz ADL. The scale assigns scores to daily activities such as bathing, dressing, toileting, mobility, continence, and feeding. Based on the total score, the individual's level of dependence is classified as follows: 0-6 points indicate dependence, 7-12 points indicate partial dependence, and 13-18 points indicate independence. Each item on the Katz ADL scale includes response options indicating whether the individual is independent, partially dependent, or dependent. The scale assesses six fundamental activities: bathing, dressing, toileting, transferring, continence, and feeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Edinburgh feeding evaluation in dementia (EdFED) scale (Nutrition) | 12 week | One standardized assessment tool administered to both the moderate and severe dementia groups at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12). These tool included the EdFED. The scale consists of 11 items and can be administered in less than five minutes. The first 10 items address feeding behaviors during meals; each item is scored based on the frequency of occurrence. If the behavior does not occur during meals, it is scored as never (0 points), if it occurs 2-3 times a week it is scored as sometimes (1 point), and if it occurs more than 4 times a week, it is scored as often (2 points). There is no cutoff score or reverse scoring in the scale. The total score obtained from the first 10 items ranges from 0 to 20, with a score of 20 indicating the most severe condition. The total score can be used to track changes in the patient's nutritional status. The level of support the patient requires is determined by item 11. |
| Cohen-Mansfield Agitation Inventory (Agitation) | 12 week | One standardized assessment tool administered to both the moderate and severe dementia groups at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12). These tool included the CMAI. The CMAI uses a Likert scale, where each item is scored from 1 never to 7 several times per hour. The total score is calculated based on a maximum of 32 items, with a possible total score range from 29 to 181. |
| Katz Daily Life Activities Scale (Daily activities) | 12 week | One standardized assessment tool administered to both the moderate and severe dementia groups at three time points: at the beginning of the study, at the midpoint (week 6), and at the end (week 12). These tool included the Katz ADL. The scale assigns scores to daily activities such as bathing, dressing, toileting, mobility, continence, and feeding. Based on the total score, the individual's level of dependence is classified as follows: 0-6 points indicate dependence, 7-12 points indicate partial dependence, and 13-18 points indicate independence. Each item on the Katz ADL scale includes response options indicating whether the individual is independent, partially dependent, or dependent. The scale assesses six fundamental activities: bathing, dressing, toileting, transferring, continence, and feeding. |
Countries
Turkey (Türkiye)
Outcome results
None listed