UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000062589
Receipt number R000069487
Scientific Title A study on the effects of educational interventions aimed at improving health literacy regarding menstrual-related symptoms in female workers of reproductive age
Date of disclosure of the study information 2026/08/16
Last modified on 2026/08/16 17:53:58

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Basic information

Public title

A study on the effects of educational interventions aimed at improving health literacy regarding menstrual-related symptoms in female workers of reproductive age

Acronym

A study on the effects of educational interventions aimed at improving health literacy regarding menstrual-related symptoms in female workers of reproductive age

Scientific Title

A study on the effects of educational interventions aimed at improving health literacy regarding menstrual-related symptoms in female workers of reproductive age

Scientific Title:Acronym

A study on the effects of educational interventions aimed at improving health literacy regarding menstrual-related symptoms in female workers of reproductive age

Region

Japan


Condition

Condition

Dysmenorrhea,Premenstrual syndrome

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim is to conduct an educational intervention for female workers of reproductive age to improve health literacy regarding menstrual-related symptoms and to examine its effectiveness.

Basic objectives2

Others

Basic objectives -Others

Relevance

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Health Literacy in Adolescence

Key secondary outcomes

Evaluation of Menstrual-Associated Symptoms, Coping Behaviors, and Educational Interventions


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

Other

Interventions/Control_1

Watching videos and viewing electronic brochures

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

18 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

Female workers aged 18 to 45 employed by a single company. Employment type, whether full-time, part-time, or temporary, does not matter.

Key exclusion criteria

No menstruation due to structural or functional reasons

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Chika
Middle name
Last name Ueda

Organization

Ehime University

Division name

Graduate School of Medicine, Department of Nursing

Zip code

791-0925

Address

Shizukawa, Toon City, Ehime Prefecture

TEL

089-960-5405

Email

m451003y@mails.cc.ehime-u.ac.jp


Public contact

Name of contact person

1st name Chika
Middle name
Last name Ueda

Organization

Ehime University

Division name

Graduate School of Medicine, Department of Nursing

Zip code

791-0925

Address

Shizukawa, Toon City, Ehime Prefecture

TEL

089-960-5405

Homepage URL


Email

m451003y@mails.cc.ehime-u.ac.jp


Sponsor or person

Institute

Ehime University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ehime University Hospital Clinical Research Ethics Committee

Address

Shizukawa, Toon City, Ehime Prefecture

Tel

089-690-5914

Email

cttc@m.ehime-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

2026 Year 08 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

33

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

No longer recruiting

Date of protocol fixation

2026 Year 01 Month 28 Day

Date of IRB

2026 Year 01 Month 28 Day

Anticipated trial start date

2026 Year 03 Month 01 Day

Last follow-up date

2026 Year 09 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

2026 Year 08 Month 16 Day

Last modified on

2026 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069487