UMIN-CTR Clinical Trial

Basic information
Public title	Development of simulation training programs to improve midwifery practice Skills and its effect
Acronym	quasi-experimental study
Scientific Title	Development of simulation training programs to improve midwifery practice Skills and its effect
Scientific Title:Acronym	Development of simulation training programs to improve midwifery practice Skills and its effect Continuing education program focused on the postpartum period
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Nursing Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effect of educational program designed to improve midwifery practice in a period of time immediately after delivery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Midwifery practice skills to the postpartum bleeding
Key secondary outcomes	Self-efficacy Self-Directed Learning Readiness (Japanese SDLRS)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Placenta after bleeding for simulation learning
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	The incumbent midwife and not Receive Recognition of Clinical Ladder of Competencies for Midwifery Practice three. Years of midwive's experience are until ten years from two years
Key exclusion criteria	A midwife receive recognition of Clinical Ladder of Competencies for Midwifery Practice three.
Target sample size	28

Research contact person
Last name of lead principal investigator	1st name Mayumi Middle name Last name Yamauchi
Organization	Graduate school of nursing Sapporo city university
Division name	doctoral program
Zip code	0600011
Address	Kita11 Nishi13, Chuo-ku, Sapporo 060-0011,JAPAN
TEL	0117262500
Email	1475002@st.scu.ac.jp

Public contact
1st name of contact person	1st name Mayumi Middle name Last name Yamauchi
Organization	Graduate school of nursing Sapporo city university
Division name	doctoral program
Zip code	0600011
Address	Kita11 Nishi13, Chuo-ku, Sapporo 060-0011,JAPAN
TEL	0117262500
Homepage URL
Email	1475002@st.scu.ac.jp

Sponsor
Institute	Graduate school of nursing Sapporo city university
Institute
Department

Funding Source
Organization	Graduate school of nursing Sapporo city university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review in Board Graduate school of nursing Sapporo city university
Address	Kita11 Nishi13, Chuo-ku, Sapporo 060-0011,JAPAN
Tel	0117262500
Email	none

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 24 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 23 Day
Date of IRB	2019 Year 04 Month 12 Day
Anticipated trial start date	2019 Year 04 Month 23 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

Management information
Registered date	2019 Year 04 Month 23 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039947