UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053758 |
|---|---|
| Receipt number | R000061346 |
| Scientific Title | Survey of Stress Conditions of University Hospital Physicians Before and After Physician Workstyle Reform |
| Date of disclosure of the study information | 2024/03/04 |
| Last modified on | 2025/09/02 16:47:10 |
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Basic information
Public title
Survey of Stress Conditions of University Hospital Physicians Before and After Physician Workstyle Reform
Acronym
Survey of Stress Conditions of University Hospital Physicians Before and After Physician Workstyle Reform
Scientific Title
Survey of Stress Conditions of University Hospital Physicians Before and After Physician Workstyle Reform
Scientific Title:Acronym
Survey of Stress Conditions of University Hospital Physicians Before and After Physician Workstyle Reform
Region
| Japan |
Condition
Condition
adjustment disorder, insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Questionnaire survey on the number of duty shifts of university hospital physicians before and after the start of the physician work style reform.
Basic objectives2
Others
Basic objectives -Others
Survey on mental health and insomnia.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
K-6 before the start of physician work style reform, k-6 after the start of physician work style reform
Key secondary outcomes
Athens Insomnia Scale before the start of the Physician Workplace Reform, Athens Insomnia Scale after the start of the Physician Workplace Reform.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physicians working at the university hospital during the survey period who agree to participate in the survey.
Key exclusion criteria
Those who do not agree to participate in the survey
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hirohisa |
| Middle name | |
| Last name | Kinoshita |
Organization
Nagasaki University
Division name
Health Center
Zip code
8528151
Address
1-14 Bunkyou,Nagasaki City
TEL
0958192212
nus-kino@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirohisa |
| Middle name | |
| Last name | kinoshita |
Organization
Nagasaki University
Division name
Health Center
Zip code
8528521
Address
1-14 Bunkyou,Nagasaki city
TEL
0958192212
Homepage URL
nus-kino@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
non
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
Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4,Sakamoto,Nagasaki City,852-8523,Japan
Tel
0958197198
gakujutu_gakuji@ml.nagasaki-u.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
長崎大学病院/Nagasaki University Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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
March 2024 Survey results. Responses were received from 150 doctors working in university hospitals.The valid response rate was 19%. Respondents were aged in their 30s (50%) and in their 40s (28%). The number of monthly on-calls at the university was 1-2 times per month (24%) and 3-4 times per month (20%). The results of this survey were presented at the 54th Kyushu Region Conference on University Health Managementin July 2024.
Results date posted
| 2024 | Year | 09 | Month | 02 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Plans to conduct three observational surveys: one before the start of the physician workforce reform, one six months after the start of the reform, and one a year later.The March 2024 survey has already been conducted. The second survey was conducted from March 24 to April 30, 2025.
Management information
Registered date
| 2024 | Year | 03 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061346
