UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054978 |
|---|---|
| Receipt number | R000062818 |
| Scientific Title | Pre-post comparative study on the effectiveness of individualized oral health education for pregnant women |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2025/03/09 21:43:12 |
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Basic information
Public title
Pre-post comparative study on the effectiveness of individualized oral health education for pregnant women
Acronym
Pre-post comparative study on the effectiveness of individualized oral health education for pregnant women
Scientific Title
Pre-post comparative study on the effectiveness of individualized oral health education for pregnant women
Scientific Title:Acronym
Pre-post comparative study on the effectiveness of individualized oral health education for pregnant women
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide individualized oral health guidance to pregnant women and to clarify changes in their oral knowledge and oral self-care (oral care, antenatal dental health checkups)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Awareness, knowledge, and behavior change regarding oral self-care and hygiene
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
Pregnant women will receive individualized oral health education through a pamphlet at maternity facilities, and a web questionnaire will be administered before and after the intervention. If face-to-face education is difficult for pregnant women due to time constraints, it will be provided via ZOOM. The number of health education sessions will be one, and the duration will be 10 minutes.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Those who are under 33 weeks gestation
Those who are able to communicate in Japanese
Those who are able to use the Zoom web conferencing system
Key exclusion criteria
Those who are with high-risk pregnancies
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Chiba |
Organization
The University of Shiga Prefecture
Division name
Graduate School of Nursing
Zip code
522-8533
Address
2500 Hassaka-cho, Hikone City, Shiga, Japan
TEL
0749-28-8665
chiba.y@nurse.usp.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Okiyama |
Organization
The University of Shiga Prefecture
Division name
Graduate School of Nursing
Zip code
522-8533
Address
2500 Hassaka-cho, Hikone City, Shiga, Japan
TEL
0749-28-8665
Homepage URL
on41aokiyama@ec.usp.ac.jp
Sponsor or person
Institute
The University of Shiga Prefecture
Institute
Department
Personal name
Funding Source
Organization
The University of Shiga Prefecture
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
Committee on Ethical Review of Research involving Human, Subjects,The University of Shiga Prefecture
Address
2500 Hassaka-cho, Hikone City, Shiga, Japan
Tel
0749-28-8612
kenkyu_shien@office.usp.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 | 07 | Month | 18 | 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
99
Results
Before and after the intervention, there was a significant increase in the number of those who took oral care after snacking, those who had a dental visit, and those who had correct answers to questions regarding the relationship between the oral cavity and dental disease, oral care methods, and knowledge about care after snacking.
Results date posted
| 2025 | Year | 03 | Month | 09 | 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
| 2024 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 15 | 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 | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062818
