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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047683
Receipt No. R000054367
Scientific Title The effect of Knowledge Learning on premenstrual syndrome on consultation and pill resistance in female college students
Date of disclosure of the study information 2022/05/09
Last modified on 2022/05/09

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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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