UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061606 |
|---|---|
| Receipt number | R000070486 |
| Scientific Title | Effects of a Manicure Intervention on Mental Function and Behavioral and Psychological Symptoms of Dementia (BPSD) in Older Women with Dementia |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/18 00:13:19 |
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Basic information
Public title
Study on the Effects of a Manicure Intervention in Older Women with Dementia
Acronym
MANI-D Study
Scientific Title
Effects of a Manicure Intervention on Mental Function and Behavioral and Psychological Symptoms of Dementia (BPSD) in Older Women with Dementia
Scientific Title:Acronym
MANI-D Trial
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effects of a manicure intervention on behavioral and psychological symptoms of dementia (BPSD), cognitive function, quality of life (QOL), and caregiver burden in older women with dementia residing in welfare facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Version of the Neuropsychiatric Inventory Nursing Home Version
Key secondary outcomes
Mini Mental State Examination-Japanese
Japanese Version of the Zarit Caregiver Burden Interview
Quality of life assessed using the Quality of Life Questionnaire for Dementia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the intervention group received a manicure intervention for approximately 15 minutes once every two weeks for 6 months. The intervention consisted of the application of a base coat, colored manicure selected by the participant, and a top coat. The intervention was conducted individually in a quiet environment while communicating face-to-face with the participants.
Interventions/Control_2
Participants in the control group received hand and nail cleansing followed by moisturizing care. The duration and frequency of the intervention were the same as those in the intervention group.
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
Female
Key inclusion criteria
1. Older women diagnosed with dementia by a physician
2. Residents of welfare facilities
3. Participants able to maintain a seated position for approximately 20 minutes during the intervention
4. Participants without skin problems or allergies affecting the hands or fingers
5. Participants who provided written informed consent personally or through a legally authorized representative
Key exclusion criteria
1. Participants who were unable to understand the study procedures or tolerate the approximately 20-minute intervention
2. Participants for whom informed consent could not be obtained from family members or legally authorized representatives
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | masanori |
| Middle name | |
| Last name | sakamoto |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Psychosocial Rehabilitation
Zip code
734-8551
Address
1-2-3 Kasumi, Minami ward, Hiroshima
TEL
082-257-5450
sakamoto@hcu.ac.jp
Public contact
Name of contact person
| 1st name | masanori |
| Middle name | |
| Last name | sakamoto |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Psychosocial Rehabilitation
Zip code
734-8551
Address
1-2-3 Kasumi, Minami ward, Hiroshima
TEL
082-257-5450
Homepage URL
sakamoto@hcu.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Sakamoto Masanori
Funding Source
Organization
None
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
Kibi International University
Address
8 Iga-cho, Takahashi City, Okayama Prefecture
Tel
082-849-6883
sakamoto@hcu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 18 | 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
120
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070486
