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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041133
Receipt No. R000046955
Scientific Title The flipped classroom is effective for medical students to improve deep tendon reflex examination skills: A mixed methods study
Date of disclosure of the study information 2020/07/17
Last modified on 2020/07/17

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Basic information
Public title The flipped classroom is effective for medical students to improve deep tendon reflex examination skills: A mixed methods study
Acronym The flipped classroom is effective for medical students to improve deep tendon reflex examination skills: A mixed methods study
Scientific Title The flipped classroom is effective for medical students to improve deep tendon reflex examination skills: A mixed methods study
Scientific Title:Acronym The flipped classroom is effective for medical students to improve deep tendon reflex examination skills: A mixed methods study
Region
Japan

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

Objectives
Narrative objectives1 The objective of this research is to investigate the effectiveness of the flipped classroom teaching methodology compared to traditional teaching method for training medical students in deep tendon reflex. The purpose of this study is also to analyze how the educational effect of the flipped classroom has affected the performance of deep tendon reflex by qualitative research.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The acquisition of deep tendon reflex were assessed with DOPS. Semi-structured focused group interview about teaching method.
Key secondary outcomes Five-Likert scale questionnaires about the confidence of deep tendon reflex examinations were assessed before and after training session.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Flipped classroom teaching method in deep tendon reflex examination
Interventions/Control_2 Traditional teaching method in deep tendon reflex examination
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
21 years-old <=
Age-upper limit
37 years-old >
Gender Male and Female
Key inclusion criteria The study population consisted of 83 medical students participating in a general medicine clerkship rotation from 2018 to 2019.
Key exclusion criteria NA
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Masatomi
Middle name
Last name Ikusaka
Organization Chiba University Hospital
Division name General Medicine
Zip code 260-8677
Address 1-8-1, Inohana, Chu-ou-ku
TEL 043-222-7171
Email ikusaka@ga2.so-net.ne.jp

Public contact
Name of contact person
1st name Shun
Middle name
Last name Uchida
Organization Chiba University Hospital
Division name General Medicine
Zip code 260-8677
Address 1-8-1, Inohana, Chu-ou-ku
TEL 043-222-7171
Homepage URL
Email shun.uchida@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization NA
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 Chiba University
Address 1-8-1, Inohana, Chu-ou-ku
Tel 043-222-7171
Email igaku-rinri@office.chiba-u.jp

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
2020 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 83
Results
In intervention group, pre-test confidence for deep tendon reflex were higher than control group. There were no statistically significant difference in post-test confidence and DOPS between intervention and control groups. Focus group interview revealed components "Active class participation" and "improvement of learning readiness" in intervention group.
Results date posted
2020 Year 07 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We received consent from all 84 medical students. The mean age of the participants was 23.1 years, of which 67% were men. 34% of the participants had prior clinical clerkship rotation in neurology.
We found no statistically significant differences between the intervention control groups. 
Participant flow
Explained individually
Adverse events
NA
Outcome measures
Mastery level for deep tendon reflex
Confidence for deep tendon reflex before/after the classroom
Plan to share IPD NA
IPD sharing Plan description NA

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 10 Month 30 Day
Date of IRB
2018 Year 10 Month 30 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2019 Year 07 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
2020 Year 07 Month 17 Day
Last modified on
2020 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046955

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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