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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name