UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056039 |
|---|---|
| Receipt number | R000064035 |
| Scientific Title | Development and validation of an infant first aid education system for childbirth education classes |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2024/11/04 15:39:59 |
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Basic information
Public title
Development and validation of an infant first aid education system for childbirth education classes
Acronym
Development and validation of an infant first aid education system for childbirth education classes
Scientific Title
Development and validation of an infant first aid education system for childbirth education classes
Scientific Title:Acronym
Development and validation of an infant first aid education system for childbirth education classes
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First aid education for parents is important for saving infants, but no educational system has been established in Japan for childbirth education classes. This study examines the validity of the educational system and self-learning materials (applications) we developed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Position, depth, rhythm, and release of chest compressions
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions use educational systems and self-learning materials (apps).Obtain data on position, depth, rhythm, and release of chest compressions before and after intervention.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
healthy woman
Key exclusion criteria
Persons who are physically burdened by performing chest compressions
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ikumi |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Nursing
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata city
TEL
025-257-4019
ikumi-sato@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ikumi |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Nursing
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata city
TEL
025-257-4019
Homepage URL
ikumi-sato@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suzuka University of Medical Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata city
Tel
025-157-4019
ikumi-sato@nuhw.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 | 12 | Month | 16 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064035
