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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039974
Receipt No. R000045577
Scientific Title Development and evaluation of 3D birth animation software for maternal safety and satisfactory delivery including husband
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/29

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Basic information
Public title Development and evaluation of 3D birth animation software for maternal safety and satisfactory delivery including husbands
Acronym Effect of birth animation
Scientific Title Development and evaluation of 3D birth animation software for maternal safety and satisfactory delivery including husband
Scientific Title:Acronym Effect of birth animation
Region
Japan

Condition
Condition Healthy maternals and husbands
Classification by specialty
Nursing Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Purpose 1: The purpose of this study is to clarify the effects of midwife's explanation of the delivery process using birth animation software on the comprehension of the delivery process and the satisfaction of delivery experience of the mothers and her husbands by comparing the intervention group and the control group.
Purpose 2: The mothers are compared to the intervention group in the 2015 study data.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Purpose 1:
Understanding of labor progress and satisfaction of birth of mothers and her husbands a.
The evaluation is after birth
Purpose 2:
Usefulness of delivery animation with additional functions
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- October 2020
Number of times:once
Intervention:Individual explanation of how of birth that uses birth animation
Interventions/Control_2 urpose1
Control group
Survey period:November 2020- October 2021
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 Male and Female
Key inclusion criteria Purpose 1,2:
Low-risk pregnancy
Low-risk birth
Purpose 2:
Three midwives
Midwife who has experience for ten years or more.
Key exclusion criteria Purpose 1,2:
Under the age of 20
High-risk pregnancy
High-risk birth
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 7-6 Hattyonishi-machi, Takatsuki, Osaka 569-0095, Japan
TEL 072-684-7033
Email ayabe@osaka-med.ac.jp

Public contact
Name of contact person
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
Homepage URL
Email ayabe@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
The Faculty of Nursing
Institute
Department

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 7-6 Hattyonishi-machi, Takatsuki, Osaka 569-0095, Japan
Tel 072-684-7033
Email ayabe@osaka-med.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2019466
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
2020 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 19 Day
Date of IRB
2019 Year 09 Month 19 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 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
2020 Year 03 Month 29 Day
Last modified on
2020 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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