UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041133 |
|---|---|
| Receipt number | 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 10:32:05 |
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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
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
shun.uchida@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046955
