UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024925 |
|---|---|
| Receipt number | R000028673 |
| Scientific Title | The effect by which the individual explanation of how of birth that uses birth animation by midwife to advance causes for the women in birth and midwife on itself |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2019/11/24 15:15:23 |
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Basic information
Public title
The effect by which the individual explanation of how of birth that uses birth animation by midwife to advance causes for the women in birth and midwife on itself
Acronym
Effect of birth animation
Scientific Title
The effect by which the individual explanation of how of birth that uses birth animation by midwife to advance causes for the women in birth and midwife on itself
Scientific Title:Acronym
Effect of birth animation
Region
| Japan |
Condition
Condition
Healthy birth
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose 1:The effect by which the individual explanation of how of birth that uses birth animation by midwife to advance causes for women in birth and midwife on itself
Purpose 2: The utility of the use of the midwife of the birth animation for the women in childbirth and the explanation of how of birth to advance is clarified by the focus group interview method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Purpose 1:
Understanding and satisfaction of the women in birth
The evaluation is after birth
Purpose 2:
Utility of explanation by birth animation
The evaluation is after the control group ends
Key secondary outcomes
Purpose 1:
1.Understanding of labor progress during pregnancy
2.Understanding of labor progress after birth
3.The birth satisfaction level
4.Evaluation of birth animation
Purpose 2:
Evaluation of focus group interview data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Purpose1
Intervention group
Survey period:After approving the ethical approval-March 2019
Number of times:once
Intervention:Individual explanation of how of birth that uses birth animation
Interventions/Control_2
Purpose1
Control group
Survey period:November 2017-June 2018
Number of times:once
Intervention:Only oral
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
| Not applicable |
Gender
Female
Key inclusion criteria
Purpose 1:
Low-risk pregnancy
Low-risk birth
Purpose 2:
Three midwives
Midwife who has experience for ten years or more
Key exclusion criteria
Purpose 1:
Under the age of 20
High-risk pregnancy
High-risk birth
Purpose 2:
New midwife
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | AYAKO |
| Middle name | |
| Last name | SASAKI |
Organization
Osaka Medical College
Division name
The Faculty of Nursing
Zip code
5690071
Address
7-6 Hattyonishi-machi, Takatsuki, Osaka 569-0095, Japan
TEL
072-684-7033
ayabe@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | AYAKO |
| Middle name | |
| Last name | AYAKO |
Organization
Osaka Medical College
Division name
The Faculty of Nursing
Zip code
5690071
Address
7-6 Hattyonishi-machi, Takatsuki, Osaka 569-0095, Japan
TEL
072-684-7033
Homepage URL
ayabe@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
The Faculty of Nursing
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Imoto Department of Obstetrics and Gynecology Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College
Address
1-4-26
Tel
09021254090
ayabe@osaka-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
28743
Org. issuing International ID_1
Japan family planning association
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
井元産婦人科医院（福井県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
149
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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study period being extended to March 31, 2020
Management information
Registered date
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2019 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028673
