UMIN-CTR Clinical Trial

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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