UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047683 |
|---|---|
| Receipt number | 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 | 2023/05/11 08:56:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
mmiyajima@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokaido University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 25 | Day |
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
| 2023 | Year | 03 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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 |
