UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048194 |
|---|---|
| Receipt number | R000054047 |
| Scientific Title | Face-to-face/on-demand preconception care for female college students - menstruation and gynecological visits. |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/12/29 09:52:26 |
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Basic information
Public title
A study of in-person and on-demand preconception education on menstruation and gynecological visits to female college students.
Acronym
A Study on the Effectiveness of Preconception Education for Female College Students
Scientific Title
Face-to-face/on-demand preconception care for female college students - menstruation and gynecological visits.
Scientific Title:Acronym
A Study on the Effectiveness of Preconception Care for Female College Students
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preconception care is implemented for the purpose of thinking about future pregnancy and childbirth and facing one's current life and health, and it has been shown that attending preconception care lectures leads to increased health-related awareness. Therefore, the purpose of this study is to implement preconception care to female university students and to clarify the educational effects of preconception care. In addition, preconception care is mainly conducted in the form of face-to-face lectures, but the use of ICT is currently being promoted in society as a result of the shift to DX. Therefore, the purpose of this study is to clarify whether online preconception care, which corresponds to DX, is as effective as face-to-face care in changing awareness and behavior.
In addition, we believe that preconception care will encourage preconception women to rethink about their own health and change their behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
By implementing the preconception care educational intervention, many of those who were in the "indifference phase" of the behavior change stage regarding gynecological consultations become in the "interest phase" or above.
Key secondary outcomes
Implementation of the preconception care educational intervention has resulted in changes in the participants' own health awareness and attitudes toward pregnancy and childbirth.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Preconception care educational intervention (approximately 20-30 minutes per session)
Mainly education on menstruation and gynecological visits
Conducted in person
Interventions/Control_2
Preconception care educational intervention (approximately 20-30 minutes per session)
Primarily education on menstruation and gynecological visits
on demand.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Female University Students (1st grade)
Key exclusion criteria
Those who cannot give consent to participate
Those who cannot read and write Japanese
Male students
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Toshiko |
| Middle name | |
| Last name | Igarashi |
Organization
Nara Medical University
Division name
Maternal Nursing
Zip code
634-8521
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
igarashi@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiko |
| Middle name | |
| Last name | Igarashi |
Organization
Nara Medical University
Division name
Maternal Nursing
Zip code
634-8521
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
Homepage URL
igarashi@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Maternal Nursing
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Nara Medical University
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
Tel
0744-22-3051
ino_rinri@naramed-u.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
奈良県立医科大学、畿央大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | 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
125
Results
PreconceptionCare was effective in both face-to-face and on-demand methods. In particular, it was suggested that the on-demand method was more effective for matters in which there was a high level of interest prior to the course. PreconceptionCare can be implemented more effectively by understanding the interests of participants in advance and devising implementation methods that match the characteristics of the participants.
Results date posted
| 2022 | Year | 12 | Month | 29 | Day |
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 | 06 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054047
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