UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048742 |
|---|---|
| Receipt number | R000055532 |
| Scientific Title | Evaluation of the Responsiveness of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS) to Burnout Changes Over Time and Burnout-Related Factors for Medical Students in Clinical Clerkship: A Prospective Cohort Study |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2023/02/20 09:02:30 |
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Basic information
Public title
Evaluation of the Responsiveness of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS) to Burnout Changes Over Time and Burnout-Related Factors for Medical Students in Clinical Clerkship: A Prospective Cohort Study
Acronym
A Prospective Cohort Study of Burnout among Medical Students in Clinical Clerkship
Scientific Title
Evaluation of the Responsiveness of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS) to Burnout Changes Over Time and Burnout-Related Factors for Medical Students in Clinical Clerkship: A Prospective Cohort Study
Scientific Title:Acronym
A Prospective Cohort Study of Burnout among Medical Students in Clinical Clerkship
Region
| Japan |
Condition
Condition
Burnout
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the OLBI-MS Japanese version in a prospective cohort study design, we will (1) test the responsiveness (longitudinal validity) of the OLBI-MS Japanese version for clinical medical school grades and (2) explore explanatory variables related to the persistence of burnout.
Basic objectives2
Others
Basic objectives -Others
prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation coefficient between change in OLBI-MS (Exhaustion) score and change in external criteria (MBI-GS Ex) score
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 23 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Medical students who have passed the Objective Structured Clinical Examination (OSCE) and Computer Based Testing (CBT) at the time of registration and are permitted to begin clinical clerkship.
2) Obtain consent from the individual to cooperate in this study.
Key exclusion criteria
1) Medical students who are not permitted to begin clinical practice for any reason at the time of registration.
2) Other subjects who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Nagoya City University Graduate School of Medical Sciences,
Division name
Department of Psychiatry and Cognitive Behavioral Medicine,
Zip code
467-8601
Address
1, Kawasumi, Mizuho-Cho, Mizuho-Ku, Nagoya, Japan
TEL
0528538271
tw28@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Nagoya City University Graduate School of Medical Sciences,
Division name
Department of Psychiatry, Cognitive and Behavioral Medicine
Zip code
467-8601
Address
1, Kawasumi, Mizuho-Cho, Mizuho-Ku, Nagoya
TEL
0528538271
Homepage URL
tw28@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences,
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee, Nagoya City University Faculty of Medicine
Address
1, Kawasumi, Mizuho-Cho, Mizuho-Ku, Nagoya
Tel
0528538271
clinical_research@med.nagoya-cu.ac.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
| 2022 | Year | 08 | Month | 24 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations
Burnout: Oldenburg Burnout Inventory Medical Student version (OLBI-MS)
Burnout: Maslach Burnout Inventory General Survey (MBI-GS)
Psychological flexibility (acceptance): Work-related Acceptance and Action Questionnaire (WAAQ)
Psychological Flexibility (Value-Aligned Behavior): Valuing Questionnaire (VQ)
Stigma of mental illness: Perceived Devaluation-Discrimination scale (PDDs)
Depression: Patient Health Questionnaire (PHQ)-9
Maltreatment by teachers or senior doctors
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055532
