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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034911
Receipt No. R000039804
Scientific Title Feasibility study of team-based learning in the Postpartum Haemorrhage of midwife student in Indonesia
Date of disclosure of the study information 2018/12/20
Last modified on 2020/12/04

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Basic information
Public title Feasibility study of team-based learning in the Postpartum Haemorrhage of midwife student in Indonesia
Acronym team-based learning in Indonesia
Scientific Title Feasibility study of team-based learning in the Postpartum Haemorrhage of midwife student in Indonesia
Scientific Title:Acronym team-based learning in Indonesia
Region
Japan

Condition
Condition student
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to examine the feasibility of team-based learning on postpartum hemorrhage topic of second-year student.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes learning outcome (knowledge and clinical reasoning)
Key secondary outcomes student learning experience

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
Other
Interventions/Control_1 two times team-based learning class, each times is 90 minutes
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
17 years-old <=
Age-upper limit
25 years-old >=
Gender Female
Key inclusion criteria no experience of team-based learning, and willingness to participate in this study
Key exclusion criteria have experience of team-based learning, and not willingness to participate in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yunefit
Middle name
Last name Ulfa
Organization St.Luke's International university, Graduate School
Division name Nursing science, Women's health & midwifery
Zip code 104-0044
Address 10-1 Akashi-cho
TEL 03-3543-6391
Email 17dn901@slcn.ac.jp

Public contact
Name of contact person
1st name Yunefit
Middle name
Last name Ulfa
Organization St.Luke's International University
Division name Nursing science, Women's health & midwifery
Zip code 3510115
Address Wako-shi, Niikura 1-14-65, room 101
TEL 03-3543-6391
Homepage URL
Email yunefit@gmail.com

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science Core to Core Program/Asia Africa Science Platform Program (2018-2021)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) St.Luke's International University scholarship for International study

IRB Contact (For public release)
Organization St.Luke's International University
Address 10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044
Tel +81-3-3543-6391
Email yunefit@gmail.com

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 Department of Midwifery Bukittinggi, Health Polytechnic Padang of the Ministry of Health of the Republic of Indonesia

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 20 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/doi/full/10.1002/nop2.623
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1002/nop2.623
Number of participants that the trial has enrolled 64
Results The mean knowledge score (0-100) was significantly higher at post-test (mean= 85.9, SD= 9.8) that at pre-test (mean = 61.4, SD = 12.9) (p=< .001). There was a significant difference in the mean clinical reasoning score (12-60) between post-test (mean = 35.4, SD = 5.8) and pre-test (mean =21.3, SD = 7.9) (p< .001). Most students (98.4 %) engaged in classroom activities.
Results date posted
2020 Year 12 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 09 Month 17 Day
Baseline Characteristics The baseline demographics of the participants with no significant differences in the demographic variables among the groups.
Participant flow There were 69 eligible students for this study. Of these 69 students, four students declined to participate, resulting in 65 students consenting to participate. Of these 65 students, one student was excluded because of insufficient data.
Adverse events No adverse events was found
Outcome measures Feasibility of the program, learning outcomes and experience
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2018 Year 12 Month 20 Day
Date of IRB
2018 Year 12 Month 13 Day
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
2019 Year 02 Month 25 Day
Date of closure to data entry
2019 Year 03 Month 15 Day
Date trial data considered complete
2019 Year 03 Month 15 Day
Date analysis concluded
2019 Year 05 Month 02 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 16 Day
Last modified on
2020 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039804

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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