UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054256 |
|---|---|
| Receipt number | R000061956 |
| Scientific Title | Evaluation of the effectiveness of a communication programme on menstruation among men and women. |
| Date of disclosure of the study information | 2024/04/25 |
| Last modified on | 2024/04/25 13:13:06 |
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Basic information
Public title
Evaluation of the effectiveness of a communication programme on menstruation among men and women.
Acronym
Evaluation of a communication programme on menstruation in men and women.
Scientific Title
Evaluation of the effectiveness of a communication programme on menstruation among men and women.
Scientific Title:Acronym
Evaluation of a communication programme on menstruation in men and women.
Region
| Japan |
Condition
Condition
dysmenorrhea
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to implement a programme for male university students and their female partners to deepen their understanding of menstruation and trigger conversations, to test the effectiveness of the programme and to collect basic data for future menstrual education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparing menstrual knowledge, menstrual conversations and menstrual behaviour before and after the programme.
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
A two-hour programme aimed at increasing men's understanding of menstruation and motivating and enabling them to practice the behaviours that their partners may want during menstruation, and to test the effectiveness of the programme.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 35 male students at Hokkaido University aged between 18 and 30 years old; 2) 35 female students aged 18 or older in a relationship with 1). In this study, subjects 1) and 2) were asked to participate in pairs.
Key exclusion criteria
Men who have experienced menstruation and their female dating partners.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Ebina |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Midwiferry, Maternity Nusing and Women's Health
Zip code
060-0812
Address
N12W5, Kita-Ku, Sapporo
TEL
011-706-2822
ebiyas@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Ebina |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Midwiferry, Maternity Nusing and Women's Health
Zip code
060-0812
Address
N12W5, Kita-Ku, Sapporo
TEL
011-706-2822
Homepage URL
ebiyas@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Yasuhiko Ebina
Funding Source
Organization
Hokkaido 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
Faculty of Health Sciences, Hokkaido University
Address
N12W5, Kita-Ku, Sapporo
Tel
011-706-3315
shomu@hs.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
| 2024 | Year | 04 | Month | 25 | 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
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061956
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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