UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059131 |
|---|---|
| Receipt number | R000067532 |
| Scientific Title | Evaluation of the Effectiveness of Counseling on Alleviating Menopausal Symptoms and Improving Sleep Parameters in Women with Menopausal Symptoms |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/11/15 23:16:47 |
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Basic information
Public title
Evaluation of the Effectiveness of Counseling on Alleviating Menopausal Symptoms and Improving Sleep Parameters in Women with Menopausal Symptoms
Acronym
Evaluation of the Effectiveness of Counseling on Alleviating Menopausal Symptoms and Improving Sleep Parameters in Women with Menopausal Symptoms
Scientific Title
Evaluation of the Effectiveness of Counseling on Alleviating Menopausal Symptoms and Improving Sleep Parameters in Women with Menopausal Symptoms
Scientific Title:Acronym
Evaluation of the Effectiveness of Counseling on Alleviating Menopausal Symptoms and Improving Sleep Parameters in Women with Menopausal Symptoms
Region
| Japan |
Condition
Condition
Menopausal disorder
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are twofold.
First, we will administer a questionnaire survey (menopausal symptoms, work productivity, and willingness to work) to working women in middle age (35-64 years) and examine whether the presence of menopausal symptoms is associated with decreases in work performance and willingness to work. Furthermore, focusing on sleep disturbance, one of the main symptoms of menopause, we will perform sleep analysis using a novel patch-type electroencephalography device in participants who provide consent and evaluate the presence or absence of sleep disturbance.
Second, among participants with menopausal symptoms and/or sleep disturbance, we will provide counseling by gynecologists specializing in menopausal care to promote behavioral changes, and then repeat the questionnaire survey and sleep analysis to examine whether menopausal symptoms and sleep parameters improve. In addition, we will assess changes in work performance and willingness to work in order to evaluate the effects of counseling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Evaluation of the association between menopausal symptoms and work-related outcomes
2.Changes in menopausal symptoms (assessed by the SMI score)
3.Changes in sleep parameters obtained from sleep electroencephalography (EEG) measurements
Key secondary outcomes
1.Changes in work-related outcomes
2.Improvement in health literacy
3.Changes in healthcare-seeking behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Encouragement to consult a medical facility
Interventions/Control_2
Cognitive-behavioral therapeutic approach or lifestyle guidan
Interventions/Control_3
no medication
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
| 35 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
An announcement will be made to female employees working at cooperating institutions regarding a seminar on menopausal disorders and an explanatory session about this project, and participants will be recruited.
Key exclusion criteria
Women who are already taking medications for menopausal symptoms (hormone replacement therapy or Kampo medicine) or sleeping pills, or who are receiving treatments such as chemotherapy that may affect the measurement results
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenjiro |
| Middle name | |
| Last name | Sawada |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3351
daasawada@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | YASUI |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3351
Homepage URL
y.yasui@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
PGV Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
4th Floor, Center of Advanced Medical Innovation, 2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 08 | 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 | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 09 | 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 | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067532
