UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048719 |
|---|---|
| Receipt number | R000055511 |
| Scientific Title | Effect of art workshops with an invited modern artist on elderly people living in a facility |
| Date of disclosure of the study information | 2022/08/22 |
| Last modified on | 2025/02/26 13:29:29 |
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Basic information
Public title
Effect of art workshops with an invited modern artist on elderly people living in a facility
Acronym
Effect of art workshops with an invited modern artist on elderly people living in a facility
Scientific Title
Effect of art workshops with an invited modern artist on elderly people living in a facility
Scientific Title:Acronym
Effect of art workshops with an invited modern artist on elderly people living in a facility
Region
| Japan |
Condition
Condition
people with dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the effects of art workshops with an invited modern artist on elderly people living in a facility for the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)The Scale of Experiencing with Regard to Arts Therapy Revised (SEAT-R) developed by Dr.Daiki Kato
Key secondary outcomes
(2) Two-dimensional Mood Scale-Short Term(TDMS-ST)(3)WHO-QOL26(4)Geriatric depression scale (GDS15) (5)Neuropsychiatric Inventory Nursing Home Version(NPI-NH)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The following program was held for subjects over 6weeks.Provision of art workshops by an invited modern artist: Participants created artwork in sessions held for 40 minutes once a week. Control: Rest time
Interventions/Control_2
The following program was held for subjects over 6weeks.Rest time. Control: Provision of art workshops by an invited modern artist: Participants created artwork in sessions held for 40 minutes once a week.
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
People with mild cognitive impairment (MCI) to moderate cognitive impairment of CDR <=2, people who can hold a conversation, people who consented to the study.
Key exclusion criteria
Visual hallucinations, severe hearing loss, severe visual impairment, unstable physical condition
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakubo |
Organization
Josai International Unversity
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyo, Togane-Shi, Chiba
TEL
0475-55-7041
kawakubo@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakubo |
Organization
Josai International University
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyo, Togane-Shi, Chiba
TEL
0475-55-7041
Homepage URL
kawakubo@jiu.ac.jp
Sponsor or person
Institute
Josai International University
Institute
Department
Personal name
Funding Source
Organization
SOYOKAZE Co., Ltd. former Unimat Retirement Community Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gunma Unversity
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Josai International University
Address
1 Gumyo, Togane-Shi, Chiba
Tel
0475-55-7832
resarch-c@jiu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社ユニマット リタイアメント・コミュニティの高齢者施設（シニアマンション）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 22 | 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
64
Results
In comparisons before and after the art intervention period, there were no significant difference in the WHO-QOL 26 and GDS scores. before and after the control period, there were no significant differences in the WHO-QOL 26 or GDS scores. With the TDMS-ST, vitality increased significantly in the finger puppet, light box, paper cut art, and corsage sessions, and arousal increased significantly in the paper cut art and corsage sessions. However, a decrease was seen in stability in the corsage session.
Results date posted
| 2025 | Year | 02 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
In the works
Date of the first journal publication of results
Baseline Characteristics
Of the 64 people who consented to the study, the participants were 39 people in whom all four measurements could be made, after excluding those who withdrew. They included six men and 33 women (mean age 87.4 plus or minus 5.7 years). There was no dementia in 21 people (54%), dementia independence level I in nine people (23%), IIa in two people (5%), and IIb in seven people (18%).
Participant flow
Six types of art workshop sessions, finger puppets, light boxes, paper cut art, first island, personal history, and corsage, were held once a week for approximately one hour by six contemporary artists.
Adverse events
no
Outcome measures
WHO-QoL26, GDS, TDMS-ST
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 23 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 29 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055511
