UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034911 |
|---|---|
| Receipt number | 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 11:56:11 |
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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
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
yunefit@gmail.com
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039804
