UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028253 |
|---|---|
| Receipt number | 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 15:27:04 |
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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
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
eriko810jp@gmail.com
Sponsor or person
Institute
International Health and Welfare University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032333
