UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037440 |
|---|---|
| Receipt number | R000042676 |
| Scientific Title | Development of menopausal symptom management using internet-based cognitive behavioral therapy for working women in climacteric states |
| Date of disclosure of the study information | 2019/10/11 |
| Last modified on | 2019/10/11 13:05:05 |
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Basic information
Public title
Development of menopausal symptom management for working women in climacteric states
Acronym
Menopausal symptom management for working women in climacteric states
Scientific Title
Development of menopausal symptom management using internet-based cognitive behavioral therapy for working women in climacteric states
Scientific Title:Acronym
Menopausal symptom management using internet-based cognitive behavioral therapy for working women
Region
| Japan |
Condition
Condition
Symptoms of menopause
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims are to develop a management program of symptoms of menopause for working women and to examine its feasibility and effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Labor productivity after 12 weeks of intervention
Key secondary outcomes
1)Symptoms on menopause after 12 weeks of intervention
2)Work Engagement after 12weeks of intervention.
3)Self-care behavior for symptoms of menopause after 12 weeks of intervention.
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
E-learning about menopausal and cognitive behavioral therapy with workshop in a small group, and 4-weeks Internet-based cognitive behavioral therapy.
Interventions/Control_2
Control group
No education
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
1) having a job
2) who having at least a smartphone,
a tablet terminal, or a personal computer.
3) are able to read and write Japanese.
Key exclusion criteria
1) having been receiving a treatment for
a psychiatric disorder
2) has been working less than 4 hours a day
3) has been participating in other intervention
research regarding with menopausal symptoms
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Mikako |
| Middle name | |
| Last name | Yoshida |
Organization
Tohoku University School of Medicine
Division name
Department of Wemen's Health Nursing & midwifery Course of Nursing, Health Science
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7956
mikako.yoshida.e2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Hashimoto |
Organization
Tohoku University School of Medicine
Division name
Department of Wemen's Health Nursing & midwifery Course of Nursing, Health Science
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7915
Homepage URL
keiko.hashimoto.q8@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University School of Medicine
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
| 2019 | Year | 10 | Month | 11 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 06 | 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
| 2019 | Year | 07 | Month | 21 | Day |
Last modified on
| 2019 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042676
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
