UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050679 |
|---|---|
| Receipt number | R000057742 |
| Scientific Title | The Online Nursing Program for the First Childbirth to Enhance the Family Resilience Affected by COVID-19 |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2023/03/27 00:47:59 |
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Basic information
Public title
The Online Nursing Program for the First Childbirth Affected by COVID-19
Acronym
The Online Nursing Program for the First Childbirth Affected by COVID-19
Scientific Title
The Online Nursing Program for the First Childbirth to Enhance the Family Resilience Affected by COVID-19
Scientific Title:Acronym
The Online Nursing Program for the First Childbirth to Enhance the Family Resilience Affected by COVID-19
Region
| Japan |
Condition
Condition
Normal health
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop The Online Nursing Program for the First Childbirth to Enhance the Family Resilience Affected by COVID-19
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The data with a semi-structured interview.
Key secondary outcomes
FRS, EPDS, online survey
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
T1: Survey of Personal context, EPDS, FRS. Take online lessons between 24-27 weeks of pregnancy and Follow-up interviews.
T2(36 weeks of pregnancy): Survey of Personal context, EPDS, FRS, and Interviews as a couple.
T3(1 month after delivery): Survey of Personal context, EPDS, FRS, and Interviews as a couple.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Couples who are planning to give birth to their first child and do not plan to receive support from their grandparents due to the COVID-19 pandemic, or are unsure
2 Japanese
3 A singleton pregnancy
4 No serious health problems including mental illness
5 Those who can watch the program online and cooperate with the interview survey
6 In the case of a couple living separately due to a job transfer away from home, they can talk on the phone, etc
Key exclusion criteria
Twin Fetus
Not married
Mental illness
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Mai |
| Middle name | |
| Last name | KOSAKA |
Organization
Chiba university
Division name
Graduate School of Nursing
Zip code
260-0856
Address
1-8-1, Inohana, chuou-ku, chiba-city, Chiba
TEL
043-222-7171
m-kosaka@chiba-u.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | MORI |
Organization
Chiba University
Division name
Graduate School of Nursing
Zip code
260-0856
Address
1-8-1, Inohana, chuou-ku, chiba-city, Chiba
TEL
043-226-2410
Homepage URL
mori@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
self-purchase
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chairman of the Ethics Review Committee, Graduate School of Nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku,Chiba city, Chiba, Japan.
Tel
+81-43-226-2462
kango-rinri@chiba-u.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 | 03 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 10 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
