UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Knowledge Learning on premenstrual syndrome on consultation and pill resistance in female college students
Acronym	The effect of Knowledge Learning on premenstrual syndrome on consultation and pill resistance in female college students
Scientific Title	The effect of Knowledge Learning on premenstrual syndrome on consultation and pill resistance in female college students
Scientific Title:Acronym	The effect of Knowledge Learning on premenstrual syndrome on consultation and pill resistance in female college students
Region	Japan

Condition
Condition	premenstrual syndrome
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of knowledge learning about premenstrual syndrome and its treatment on resistance to the pill and medical consultation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Knowledge and symptom assessment of premenstrual syndrome Assessment of resistance to hospital visits and taking the pill Ten Item Personality Inventory Brief Core Schema Scale
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	Other
Interventions/Control_1	Watching videos on premenstrual syndrome knowledge and treatment
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	40 years-old >
Gender	Female
Key inclusion criteria	Women attending college Those experiencing regular menstruation
Key exclusion criteria	Those who have irregular menstruation Those who have lived in a country other than Japan before entering university
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Maki Middle name Last name Miyajima
Organization	Hokkaido University
Division name	Graduate School of Health Sciences
Zip code	060-0812
Address	Kita 12, Nishi 5, Kita-ku, Sapporo
TEL	011-706-2350
Email	mmiyajima@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Maki Middle name Last name Miyajima
Organization	Hokkaido University
Division name	Department of Rehabilitation Science, Faculty of Health Sciences
Zip code	060-0812
Address	Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL	0117062350
Homepage URL
Email	mmiyajima@pop.med.hokudai.ac.jp

Sponsor
Institute	Hokaido University
Institute
Department

Funding Source
Organization	self-procurement
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	Hokkaido University
Address	Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel	0117062350
Email	mmiyajima@pop.med.hokudai.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	2022 Year 05 Month 09 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	2022 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 09 Day
Last follow-up date	2022 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	2022 Year 05 Month 09 Day
Last modified on	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054367

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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