UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062931 |
|---|---|
| Receipt number | R000072053 |
| Scientific Title | Implementation and Evaluation of a Program Aimed at Promoting Continued Self-Care Among Menopausal Women |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/09/15 13:44:22 |
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Basic information
Public title
Implementation and Evaluation of a Program Aimed at Promoting Continued Self-Care Among Menopausal Women
Acronym
Menopausal Self-Care Program(MSCP)
Scientific Title
Implementation and Evaluation of a Program Aimed at Promoting Continued Self-Care Among Menopausal Women
Scientific Title:Acronym
Menopausal Self-Care Program(MSCP)
Region
| Japan |
Condition
Condition
Menopausal women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of participating in a menopausal self-care program on the maintenance of self-care for improving daily lifestyle and menopausal symptoms, as well as its efficacy on menopausal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Evaluation of the Simplified Menopausal Index (SMI) score [Time point: Baseline, 1 month post-program]
2. Implementation rate of the self-monitoring sheet (status of self-care maintenance) [Time point: 1 month post-program]
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A single-session, face-to-face menopausal self-care program will be conducted. The same program will be held twice, and participants will attend one of the sessions. Following the program, a 1-month self-care implementation and maintenance support will be provided. The specific contents are as follows:
1. Lecture: Basic knowledge of menopause, explanation of measurement results (SMI, BMI/body fat percentage, blood pressure, bone mineral density, FFQ), and guidance on daily lifestyle (coping with symptoms, diet, and exercise).
2. Individual work: Participants fill out a self-monitoring sheet regarding lifestyle improvements they intend to make.
3. Group discussion: Sharing the contents of the individual work in small groups of 3-4 people. One facilitator (researcher or research assistant) will join each group.
4. Overall sharing and wrap-up: Facilitators introduce the discussion summary, followed by a Q&A session and explanation of the next steps.
5. Maintenance support and evaluation: Two weeks after the program, an email prompting self-care maintenance will be sent. Participants are encouraged to work on their goals and complete the self-monitoring sheet for 1 month, and will be evaluated via an online survey form sent by email 1 month later.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Japanese women in their 40s or 50s who wish to participate in this program.Those who have read the participant information sheet and voluntarily applied to cooperate with the study.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Kawashiro |
Organization
Chiba Prefectural University of Health Schiences
Division name
Department of Nursing
Zip code
261-0014
Address
2-10-1 Wakaba, Mihama-ku, Chiba-shi, Chiba, Japan
TEL
0432962000
yukiko.kawashiro@cpuhs.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Kawashiro |
Organization
Chiba Prefectural University of Health Schiences
Division name
Department of Nursing
Zip code
261-0014
Address
2-10-1 Wakaba, Mihama-ku, Chiba-shi, Chiba, Japan
TEL
0432962000
Homepage URL
yukiko.kawashiro@cpush.ac.jp
Sponsor or person
Institute
Chiba Prefectural University of Health Schiences
Institute
Department
Personal name
Funding Source
Organization
Chiba Prefectural University of Health Schiences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Prefectural University of Health Schiences
Address
2-10-1 Wakaba, Mihama-ku, Chiba-shi, Chiba, Japan
Tel
0432962000
yukiko.kawashiro@cpuhs.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 | 09 | Month | 15 | 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
| 2026 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 27 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072053
