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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048572
Receipt No. 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 2022/08/03

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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
Email 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
Email tw28@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 08 Month 04 Day
Date of IRB
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
2022 Year 08 Month 03 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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