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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038062
Receipt No. R000043387
Scientific Title The Effects of Team-based Learning in the Postpartum Hemorrhage Topic for Midwife Student in Indonesia: A Quasi Experimental Design
Date of disclosure of the study information 2019/10/04
Last modified on 2020/12/04

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Basic information
Public title The Effects of Team-based Learning in the Postpartum Hemorrhage Topic for Midwife Student in Indonesia
Acronym TBL in Indonesia
Scientific Title The Effects of Team-based Learning in the Postpartum Hemorrhage Topic for Midwife Student in Indonesia: A Quasi Experimental Design
Scientific Title:Acronym TBL in Indonesia
Region
Japan

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

Objectives
Narrative objectives1 This study aimed to evaluate the effect of team-based learning on Postpartum hemorrhage (PPH) topic of second-year midwifery student in Indonesia
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 Knowledge retention and learning experience

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Three times of team-based learning class, 90 minutes each time.
Interventions/Control_2 Three times of lecture class, 90 minutes each time.
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 TBL, completed previous semester credits and willingness to participate in this study
Key exclusion criteria have experience of TBL, not completed previous semester credits and not willingness to participate in this study
Target sample size 100

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, Chuo-ku, Tokyo 104-0044
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 Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Indonesia Endowment Fund for Education

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 Health Polytechnic Padang of the Ministry of Health of the Republic of Indonesia

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 04 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 115
Results Demographic data and pre-test were not significantly different between the two groups. The mean knowledge score were significantly higher among TBL students compared to the control group at post-test (p> 0.001). As for the clinical reasoning score, there was a significant improvement of students in the TBL groups compare to lecture groups at post-test and 2 weeks post-test. The learning experience showed that the intervention group had a significantly higher score compared to the control group.
Results date posted
2020 Year 12 Month 04 Day
Results Delayed
Results Delay Reason Data processing
Date of the first journal publication of results
Baseline Characteristics Age, last educational background, Future clinical midwife profession and Grade point Average (GPA)
Participant flow 118 Assessed for Eligibility - 115
Cluster randomized (3 drop out)-62
Allocated to Intervention group and 53
Allocated to Control group.



Adverse events There was no adverse events during the intervention
Outcome measures knowledge, clinical reasoning and learning experience
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 08 Month 10 Day
Date of IRB
2019 Year 09 Month 17 Day
Anticipated trial start date
2019 Year 10 Month 15 Day
Last follow-up date
2020 Year 02 Month 21 Day
Date of closure to data entry
2020 Year 04 Month 15 Day
Date trial data considered complete
2020 Year 04 Month 15 Day
Date analysis concluded
2020 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 09 Month 20 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=R000043387

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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