Status Approved
First Submitted Date
2020/02/05
Registered Date
2020/02/07
Last Updated Date
2020/02/05
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0004715 |
|---|---|
| Unique Protocol ID | CUPIRB-2018-047 |
| Public/Brief Title | Proposal of Educational Contents for Improving Menstrual and Menstrual Product of Young Adults |
| Scientific Title | Differences in Men's and Women's Perceptions of Menstrual and Menstrual Product among College Students |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | CUPIRB-2018-047 |
| Approval Date | 2018-12-03 |
| Institutional Review Board Name | the institutional review board of the Catholic University of Busan |
| Institutional Review Board Address | 57, Oryundae-ro, Geumjeong-gu, Busan |
| Institutional Review Board Telephone | 051-510-0745 |
| Data Monitoring Committee |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Jisan Lee |
| Title | Ph.D. |
| Telephone | +82-41-540-9537 |
| Affiliation | Hoseo University |
| Address | (31499) 301, RIC building, 20, Hoeo-ro 79 beon-gil, Baebang-eup, Asan-si, Chungcheongnam-do, Republic of Korea |
| Contact Person for Public Queries | |
| Name | Jisan Lee |
| Title | Ph.D. |
| Telephone | +82-41-540-9537 |
| Affiliation | Hoseo University |
| Address | (31499) 301, RIC building, 20, Hoeo-ro 79 beon-gil, Baebang-eup, Asan-si, Chungcheongnam-do, Republic of Korea |
| Contact Person for Updating Information | |
| Name | Jisan Lee |
| Title | Ph.D. |
| Telephone | +82-41-540-9537 |
| Affiliation | Hoseo University |
| Address | (31499) 301, RIC building, 20, Hoeo-ro 79 beon-gil, Baebang-eup, Asan-si, Chungcheongnam-do, Republic of Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2018-12-03 Actual | |
| Target Number of Participant | 184 | |
| Primary Completion Date | 2019-01-31 , Actual | |
| Study Completion Date | 2019-05-03 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | The Catholic University of Pusan | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2018-12-03 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | National Research Foundation |
| Organization Type | Government |
| Project ID | NRF-2018R1C1B5030802 |
| 2. Source of Monetary/Material Support | |
| Organization Name | The Catholic University of Pusan |
| Organization Type | University |
| Project ID | 과제번호 없음 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | The Catholic University of Pusan |
| Organization Type | University |
7. Study Summary
| Lay Summary | Background: Traditional methods of menstrual education use lectures and a directed towards women. This study aimed to design an innovative menstrual education (ME) that reflects both young women’s and men’s needs, and verified its effectiveness. Methods: To achieve this purpose, a new ME contents were designed and developed. For determining the needs of ME and checking knowledge and perception of menstruation and menstruation products of young adults, a mixed method was used. There were 17 young adults in focus group interview and 150 in online survey. After designing a ME, 10 young adults participated in ME. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Health Services Research |
| Phase | Phase0 |
| Intervention Model | Single Group |
| Blinding/Masking | Open |
| Allocation | Not Applicable |
| Intervention Type | Others (Menstrual education) |
| Intervention Description | a multi-experimental menstrual education (MEME) The MEME ultimately utilized hands-on exposure to 60 menstrual products, simulations of the products use with a female perineal model, watching YouTube video that we created and OX quiz, and question-and-answer sessions with menstrual experts. |
| Number of Arms | 1 |
| Arm 1 |
Arm Label Young Adults |
|
Target Number of Participant 10 |
|
|
Arm Type Experimental |
|
|
Arm Description Survey was conducted before and after the multi-experimental menstrual education (MEME) |
9. Subject Eligibility
| Condition(s)/Problem(s) |
Not Applicable-Education
Healthy young adults(men and women) |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 20Year~29Year |
|
|
Description The eligible participants were women 20 years or older that had graduated from high school and were unmarried. These criteria were applied to ensure a population with similar ME experience and because marriage and pregnancy could affect women’s experience with menstruation and menstrual products. |
|
| Exclusion Criteria |
Exclusion Criteria: Married women and men over 20 years old. This criterion was applied to ensure a population with similar ME experience. The reason is that marriage and pregnancy can affect your experience with menstruation and menstrual products. |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Menstrual Knowledge and Perception |
|
| Timepoint | Before and After ME(Menstrual Education) |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Menstrual Product Knowledge and Perception |
|
| Timepoint | Before and After ME(Menstrual Education) |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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