UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051089 |
|---|---|
| Receipt number | R000058261 |
| Scientific Title | Development and Feasibility Study of Educational Program for Midwives, Nurses, and Public Health Nurses Providing Preconception Care: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/11/15 11:57:26 |
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Basic information
Public title
Development and Feasibility Study of Educational Program for Midwives, Nurses, and Public Health Nurses Providing Preconception Care: A Pilot Randomized Controlled Trial
Acronym
Development and Feasibility Study of Educational Program for Midwives, Nurses, and Public Health Nurses Providing Preconception Care: A Pilot Randomized Controlled Trial
Scientific Title
Development and Feasibility Study of Educational Program for Midwives, Nurses, and Public Health Nurses Providing Preconception Care: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Development and Feasibility Study of Educational Program for Midwives, Nurses, and Public Health Nurses Providing Preconception Care: A Pilot Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Preconception health
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
i. To develop and assess the needs and effect of educational programs for midwives, nurses, and public health nurses who have the potential to provide preconception care.
ii. To assess the feasibility and acceptability of a trial protocol design to inform the design of future definitive randomized controlled trials.
Basic objectives2
Others
Basic objectives -Others
Feasibility study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge test.
Difference in the distribution of scores between the pre-intervention test and post-intervention test between the intervention group and the control group will be computed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Educational programs for preconception care providers who are nursing professionals
Interventions/Control_2
No Intervention
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The inclusion criteria are (a) qualified midwives, nurses, or public health nurses, and (b) those who are involved in providing preconception care to women of reproductive age or are interested in doing so.
Key exclusion criteria
No exclusion criteria
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Suzuki |
Organization
St. Luke's international university
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
0335436391
21dn007@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Suzuki |
Organization
St. Luke's international university
Division name
Graduated School of Nursing Science
Zip code
104-0044
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
0335436391
Homepage URL
21dn007@slcn.ac.jp
Sponsor or person
Institute
St. Luke's international university
Institute
Department
Personal name
Funding Source
Organization
Yamaji Fumiko Nursing Research Fund [2021]
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's international university
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
Tel
0335436391
21dn007@slcn.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
| 2023 | Year | 06 | 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
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
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058261
