UMIN-CTR Clinical Trial

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