UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049400 |
|---|---|
| Receipt number | R000055886 |
| Scientific Title | Healthy from Pregnancy-Benefits of the Classroom |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2023/05/08 14:42:36 |
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Basic information
Public title
Healthy from Pregnancy-Benefits of the Classroom
Acronym
Healthy from Pregnancy-Benefits of the Classroom
Scientific Title
Healthy from Pregnancy-Benefits of the Classroom
Scientific Title:Acronym
Healthy from Pregnancy-Benefits of the Classroom
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Nursing | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of a healthy pregnancy and wellness class on the couple's partnership.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measure changes before and after the class based on the responses of couples who attended the class in a series of three sessions pre class, and items from a self-administered questionnaire. The main outcome will be a couple intimacy scale.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention included the following items in three classroom sessions: one 120-minutes session of content was conducted by the research team (public health nurses) in an online classroom.1. Communication basics 2. Problem solving basics 3. Fatigue management
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The 10 compels in the second trimester pf pregnancy residing in the A prefecture, who wish to participate in all three classes.
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Ueda |
Organization
Sapporo Medical University
Division name
Department of Nursing School of Health Science
Zip code
0608556
Address
South1 West 17, Chuo-ku, Sapporo,060-8556
TEL
011-611-2111
iueda@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Ueda |
Organization
Sapporo Medical University
Division name
Department of Nursing School of Health Science
Zip code
0608556
Address
South1 West 17, Chuo-ku, Sapporo,060-8556
TEL
011-611-2111
Homepage URL
iueda@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Grants-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Ethics Committee
Address
South1 West 17, Chuo-ku, Sapporo,060-8556
Tel
0116112111
iueda@sapmed.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
| 2022 | Year | 11 | Month | 02 | 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
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055886
| Research Plan | |
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| 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 |
