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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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
Registered date File name

Research case data
Registered date File name