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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028253
Receipt No. R000032333
Scientific Title Development and evaluation of self-care learning program for working women with premenstrual syndrome
Date of disclosure of the study information 2017/07/16
Last modified on 2019/08/05

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Basic information
Public title Development and evaluation of self-care learning program for working women with premenstrual syndrome
Acronym Development and evaluation of self-care learning program for working women with premenstrual syndrome
Scientific Title Development and evaluation of self-care learning program for working women with premenstrual syndrome
Scientific Title:Acronym Development and evaluation of self-care learning program for working women with premenstrual syndrome
Region
Japan

Condition
Condition premenstrual syndrome
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and evaluate a self-care learning program for working women with premenstrual syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PMS symptoms by PMDD evaluation table
3 months after the start of the 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 Self-care education for 3 months
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
20 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria Premenstrual syndrome Medium and Severe
Office worker
Persons who have not carried out self-care
Those who can acquire the consent of research participation by voluntary intention from the principal in writing
Key exclusion criteria Gynecological diseases, others with disorders
Those receiving hormone therapy
Persons whose menstrual cycle is not normal
Those who can not continue for three months
Person who does not own smart phone or computer or tablet
Those with children
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumi Aizawa
Organization International Health and Welfare University Graduate School
Division name Odawara Campus
Zip code
Address 1-2-251 Shiroyama, Odawara City, Kanagawa
TEL 0465-21-6500
Email aizawa13@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eriko Suruga
Organization International Health and Welfare University Graduate School
Division name Research student
Zip code
Address 1-2-251 Shiroyama, Odawara City, Kanagawa
TEL 0465-21-6500
Homepage URL
Email eriko810jp@gmail.com

Sponsor
Institute International Health and Welfare University Graduate School
Institute
Department

Funding Source
Organization Seitoku 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
Address
Tel
Email

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
2017 Year 07 Month 16 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 51
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 Main results already published
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
2018 Year 01 Month 24 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2019 Year 10 Month 30 Day
Date of closure to data entry
2019 Year 10 Month 30 Day
Date trial data considered complete
2019 Year 10 Month 30 Day
Date analysis concluded
2020 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 16 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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