UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038062
Receipt number 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 12:10:25

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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 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

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

Value
https://center6.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