UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048572 |
|---|---|
| Receipt number | R000055349 |
| Scientific Title | Validation of the validity and reliability of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS) |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2023/02/20 09:03:49 |
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Basic information
Public title
Validation of the validity and reliability of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS)
Acronym
Validation of the validity and reliability of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS)
Scientific Title
Validation of the validity and reliability of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS)
Scientific Title:Acronym
Validation of the validity and reliability of the Japanese version of the Oldenburg Burnout Inventory Medical Student version (OLBI-MS)
Region
| Japan |
Condition
Condition
burnout
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A verification of the reliability and validity of the Japanese version of the OLBI-MS
Basic objectives2
Others
Basic objectives -Others
A verification of the reliability and validity of the Japanese version of the OLBI-MS
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity and reliability of the Japanese version of the OLBI-MS
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 start clinical practice.
2) Obtain consent to cooperate in this study from the individual.
Key exclusion criteria
1) Medical students who are not permitted to begin clinical practice for any reason at the time of enrollment
2) Other persons deemed inappropriate as research subjects by the principal investigator (subinvestigator)
Target sample size
160
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, Cognitive and Behavioral Medicine
Zip code
467-8601
Address
1, Kawasumi, Mizuho-Cho, Mizuho-Ku, Nagoya.
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
Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
0528525511
tw28@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 | 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
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 | 04 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single cross-sectional study, and the observation and examination items are as follows.
1) Oldenburg Burnout Inventory-Medical Student version (OLBI-MS) Japanese version
2) Maslach Burnout Inventory General Survey (MBI-GS) Japanese version
3) Work-related Acceptance and Action Questionnaire (WAAQ) Japanese version
4) Psychological Flexibility (Valuing Aligned Behavior) (Valuing Questionnaire: VQ) Japanese version
5) Stigma of Mental Illness (Perceived Devaluation-Discrimination scale (PDDs) Japanese version
6) Depression scale (Patient Health Questionnaire-9: PHQ-9) Japanese version
7) Frequency of ill-treatment received from instructors and senior doctors
8) Demographic characteristics data: age, gender, sex, marital status/children, presence of a roommate, drinking more than 3 days a week, part-time work, club activities, and previous enrollment in other faculties
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | 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=R000055349
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
