UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035934 |
|---|---|
| Receipt number | R000035421 |
| Scientific Title | Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/02/19 14:16:32 |
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Basic information
Public title
Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Acronym
Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Scientific Title
Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Scientific Title:Acronym
Effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth among young women: a quasi-randomized control study
Region
| Japan |
Condition
Condition
birth
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study was to assess the effectiveness of a childbirth preparation program aiming to raise awareness about the need to prepare physically and to clarify perceptions regarding the options available for childbirth, such as the type and place, among young women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate changes in hope for giving birth in the future and in interest concerning birthing method and birth place using VAS (visual analogue scale).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participation is one day. We distribute pamphlets and give lectures on childbirth and health to intervention groups.
Interventions/Control_2
We distribute pamphlets to control group.
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
Inclusion criteria are first grade nursing college university and general female college students aged 18 and over, 24 years old or younger.
Key exclusion criteria
Exclusion criteria are men and those who have already taken maternity nursing studies, those who are experienced in pregnancy and childbirth.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomi Tamura |
Organization
Graduate School of Nara Medical University
Division name
Graduate School of Nursing
Zip code
Address
840 Shijyo-cho, Kashihara-shi, Nara-ken
TEL
0744-22-3051
n.7323@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi Tamura |
Organization
Graduate School of Nara Medical University
Division name
Graduate School of Nursing
Zip code
Address
840 Shijyo-cho, Kashihara-shi, Nara-ken
TEL
0744-22-3051
Homepage URL
n.7323@naramed-u.ac.jp
Sponsor or person
Institute
Graduate School of Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2019 | Year | 04 | 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
| 2018 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035421
