UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057508 |
|---|---|
| Receipt number | R000065673 |
| Scientific Title | Effectiveness of a Play Program Using Akachan Dolls for Elderly Residents in Institutions |
| Date of disclosure of the study information | 2025/04/06 |
| Last modified on | 2025/04/06 22:18:25 |
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Basic information
Public title
Effectiveness of a Play Program Using Akachan Dolls for Elderly Residents in Institutions
Acronym
Effectiveness of a Play Program Using Akachan Dolls for Elderly Residents in Institutions
Scientific Title
Effectiveness of a Play Program Using Akachan Dolls for Elderly Residents in Institutions
Scientific Title:Acronym
Effectiveness of a Play Program Using Akachan Dolls for Elderly Residents in Institutions
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of the "Play with Baby Dolls Program" for the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) NPI-NH (assessment of nursing care burden and severity of BPSD of facility staff), (2) QOL-D (QOL assessment of elderly dementia patients), (3) Face Scale (QOL assessment of elderly dementia patients), (6) Play (play) program evaluation form using a baby doll
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The "PLay Program with Baby Dolls" will be implemented with "Taatan" dolls on the elderly in a senior care facility and evaluated before and after. The program consists of a menu of 12 sessions. The program will be implemented once or twice a week depending on the convenience of the facility. 1 to 12 sessions will be conducted. (Intervention period: 1.5 to 3 months.) The implementation period will be from the approval of the Ethics Committee in 2025 to the end of November 2025. (conducting reminiscence using the baby dolls). The baby dolls will be given to the research subjects who have given their consent before the start of the research, and the reminiscence method will be conducted with them. In the first half of the program, each baby doll will be named by the research subjects. The names will then be introduced in a group consisting of the elderly subjects and research assistants who have given their consent before the start of the study. In the second half of the program, a play session will be conducted in a group consisting of several to nine elderly subjects and three research assistants who have given their consent before the start of the study, based on the theme of the reminiscence method. The play will be followed by a farewell ceremony for the baby dolls. After the first six sessions, singing will be included from the sixth to the twelfth session.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Target Elderly Persons
(1) Persons residing in facilities where elderly people live
(2) Persons who have been diagnosed with dementia or who have a level of independence in daily living I or higher for the elderly with dementia
(3) Persons who have given consent for the research survey
Caregivers
(1) Must be a staff member who routinely cares for elderly residents in a facility where they live
(2) Who have given consent for the research study
Key exclusion criteria
Target Elderly Persons
Persons with illnesses that would interfere with their participation in this study (persons who have been advised by their physicians not to participate).
Caregivers
The employee must be a staff member who does not normally care for elderly residents in a facility where the elderly live.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Uchida |
| Middle name | |
| Last name | Yoko |
Organization
Graduate School of Health Sciences, Gunma University
Division name
Graduate School of Health Sciences, Gunma University
Zip code
371-0034
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8931
yuchida@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Uchida |
| Middle name | |
| Last name | Yoko |
Organization
Graduate School of Health Sciences, Gunma University
Division name
Graduate School of Health Sciences, Gunma University
Zip code
371-0034
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8931
Homepage URL
yuchida@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Health Sciences, Gunma University
Address
3-39-22 Showa-machi, Maebashi, Gunma
Tel
027-220-8931
yuchida@gunma-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HS2024-288
Org. issuing International ID_1
Gunma University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065673
