UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061259 |
|---|---|
| Receipt number | R000070004 |
| Scientific Title | Effects of Skincare on Sleep Quality in Mothers of Children with Disabilities |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/14 17:35:26 |
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Basic information
Public title
Sleep Quality in Mothers with Disabilities and the Effects of Basic Skincare Products
Acronym
Sleep Study in Mothers of Children with Disabilities study
Scientific Title
Effects of Skincare on Sleep Quality in Mothers of Children with Disabilities
Scientific Title:Acronym
Sleep Study of Mothers of Children with Disabilities
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the quality of sleep among mothers of children with disabilities and to examine whether fragrances ( skincare products) can contribute to its improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective sleep quality
Key secondary outcomes
Subjective sleep, psychological, physiological, and physical functioning
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
| Other |
Interventions/Control_1
Continuous use of skincare products containing fragrance components
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Adult women who are mothers of children with disabilities and are able to provide informed consent to participate in the study
Key exclusion criteria
Participants who may affect study participation, safety, or data validity will be excluded.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Suzuki |
Organization
Saga University
Division name
Department of Nursing, Faculty of Medicine
Zip code
8498501
Address
Department of Nursing, Faculty of Medicine, Saga University, 5-1-1 Nabeshima,
TEL
0952342555
chiekosu@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Suzuki |
Organization
Saga Univewrsity
Division name
Department of Nursing, Faculty of Medicine
Zip code
8498501
Address
Department of Nursing, Faculty of Medicine, Saga University, 5-1-1 Nabeshima
TEL
0952342555
Homepage URL
chiekosu@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga 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
Ethics Committee of the Faculty of Medicine, Saga University
Address
5-1-1 Nabeshima, Saga City, Saga, Japan
Tel
0952-31-6511
medsosou@mail.admin.saga-u.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
佐賀県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 14 | 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
9
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070004
