DementiaNCT04120103
Doll Therapy on Patients With Moderate and Severe Dementia
A study testing Doll therapy and Routine nursing care in people with Dementia, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Dementia
- What is being tested?
- Doll therapy and Routine nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2019to 30 Oct 2019
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Doll Therapy on the Cognitive States and Agitation Levels of 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Doll therapy, Routine nursing care
- Keywords
- Dementia, Agitation, Cognitive status, Doll therapy
- 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
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Doll therapy | Experimental | 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. Receives: Behavioral: Doll therapy |
| Routine nursing care | Active comparator | 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. Receives: Other: Routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental Test
cognitive status
Measured: 2 months after the beginning intervention.
Cohen-Mansfield Agitation Inventory
Cognitive and agitation status
Measured: 2 months after the beginning intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start8 Apr 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile KÜTMEÇ YILMAZ, Aksaray University Training and Research Hospital
- Investigators
- Cemile KÜTMEÇ YILMAZ, Dr, Principal investigator, Aksaray University, Faculty of Health Science, Nursing Department, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120103
- Sponsor's protocol ID
- 2017/81
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yilmaz CK, Asiret GD. The Effect of Doll Therapy on Agitation and Cognitive State in Institutionalized Patients With Moderate-to-Severe Dementia: A Randomized Controlled Study. J Geriatr Psychiatry Neurol. 2021 Sep;34(5):370-377. doi: 10.1177/0891988720933353. Epub 2020 Jun 17.
PubMed 32552299
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Doll Therapy on the Cognitive States and Agitation Levels of Patients With Moderate and Severe Dementia
- ClinicalTrials.gov ID
- NCT04120103
- Acronym / sponsor ID
- 2017/81
- Conditions
- Dementia
- Keywords
- Dementia, Agitation, Cognitive status, Doll therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 9 Oct 2019 (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.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doll therapy | Experimental | Behavioral: Doll therapyExperimental: 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. |
| Routine nursing care | Active comparator | Other: Routine nursing careThe 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. |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 therapyThe 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. | Behavioural | Doll therapy |
| Routine nursing careThe 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. | Other | Routine nursing care |
Primary outcome
Standardized Mini Mental Test
Time frame: 2 months after the beginning intervention.
cognitive status
Cohen-Mansfield Agitation Inventory
Time frame: 2 months after the beginning intervention
Cognitive and agitation status
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 12 Aug 2021.
- Derived from this study: PubMed 32552299Yilmaz CK, Asiret GD. The Effect of Doll Therapy on Agitation and Cognitive State in Institutionalized Patients With Moderate-to-Severe Dementia: A Randomized Controlled Study. J Geriatr Psychiatry Neurol. 2021 Sep;34(5):370-377. doi: 10.1177/0891988720933353. Epub 2020 Jun 17.
- Individual participant dataSharing planned: No
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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.
Cemile KÜTMEÇ YILMAZ, Dr principal investigator
Aksaray University, Faculty of Health Science, Nursing Department, Turkey
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 and Routine nursing care in people with Dementia, run by Aksaray University Training and Research Hospital 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 4 inclusion and 3 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 12 Aug 2021. 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?
Standardized Mini Mental Test (time frame: 2 months after the beginning intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120103, which also lists 1 linked publication.
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 12 Aug 2021.