DementiaDTNCT06578819
Doll Therapy for Agitated Elderly Dementia People
A study testing doll therapy in people with Dementia and Agitation, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- doll therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kelkit State Hospital
Kelkit, Gümüşhane Province, 29600
About this study
Official title: Evaluating the Impact of Doll Therapy on Agitation, Nutritional Status, and Activities of Daily Living in Agitated Older Adults With Dementia: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- doll therapy
- Keywords
- dementia, doll therapy, nursing, daily activity, nutrition
- Medical subject headings
- Dementia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doll therapyBehavioural
Doll therapy applied to the experimental group 4 days a week.
| Study group | Role | What they receive |
|---|---|---|
| experimental group (moderate dementia) | Experimental | 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 Receives: Behavioral: doll therapy |
| control group (moderate dementia) | No intervention | 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). |
| experimental group (severe dementia) | Experimental | 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 Receives: Behavioral: doll therapy |
| control group (severe dementia) | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Edinburgh feeding evaluation in dementia (EdFED) scale (Nutrition)
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.
Measured: 12 week
Cohen-Mansfield Agitation Inventory (Agitation)
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.
Measured: 12 week
Katz Daily Life Activities Scale (Daily activities)
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.
Measured: 12 week
Secondary outcomes (3)
The Edinburgh feeding evaluation in dementia (EdFED) scale (Nutrition)
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.
Measured: 12 week
Cohen-Mansfield Agitation Inventory (Agitation)
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.
Measured: 12 week
Katz Daily Life Activities Scale (Daily activities)
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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Dec 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre-test and post-test case control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYNUR CİN, Gümüşhane Universıty
- Investigators
- AYNUR CIN, DR, Study director, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578819
- Sponsor's protocol ID
- 25/10/2023 date and 2023/5
- Acronym
- DT
- Status last verified
- Jul 2025
- First submitted
- 27 Aug 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: STUDY PROTOCOL
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Doll Therapy on Agitation, Nutritional Status, and Activities of Daily Living in Agitated Older Adults With Dementia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06578819
- Acronym / sponsor ID
- DT / 25/10/2023 date and 2023/5
- Keywords
- dementia, doll therapy, nursing, daily activity, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- pre-test and post-test case control
| Arm | Type | Receives |
|---|---|---|
| experimental group (moderate dementia) | Experimental | Behavioral: doll therapyPrior 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 |
| control group (moderate dementia) | No intervention | –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). |
| experimental group (severe dementia) | Experimental | Behavioral: doll therapyPrior 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 |
| control group (severe dementia) | No intervention | –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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doll therapyDoll therapy applied to the experimental group 4 days a week. | Behavioural | experimental group (moderate dementia), experimental group (severe dementia) |
Primary outcome
The Edinburgh feeding evaluation in dementia (EdFED) scale (Nutrition)
Time frame: 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)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
The Edinburgh feeding evaluation in dementia (EdFED) scale (Nutrition)
Time frame: 12 week
Cohen-Mansfield Agitation Inventory (Agitation)
Time frame: 12 week
Katz Daily Life Activities Scale (Daily activities)
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Yes. STUDY PROTOCOL
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYNUR CIN, DR study director
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doll therapy in people with Dementia and Agitation, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Edinburgh feeding evaluation in dementia (EdFED) scale (Nutrition) (time frame: 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.