UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019247 |
|---|---|
| Receipt number | R000022249 |
| Scientific Title | Survey of operating surgeon stress using heart rate variability |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2020/05/23 08:32:12 |
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Basic information
Public title
Survey of operating surgeon stress using heart rate variability
Acronym
Survey of operating surgeon stress
Scientific Title
Survey of operating surgeon stress using heart rate variability
Scientific Title:Acronym
Survey of operating surgeon stress
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Cardiology | Anesthesiology | Laboratory medicine |
| Operative medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify surgeon stress during operation using heart rate variability,
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variabirity analysis
Key secondary outcomes
Job Content Questionnaire(JCQ)
Saliva amylase test
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Anesthesiologist, surgion, nurse and resident who work in the operating room.
Key exclusion criteria
Medical history of diabetes mellitus, ischemic heart disease or atrial fibrillation.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Asamoto |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology, and Pain Relief Center
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
asamoto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Masaaki |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology, and Pain Relief Center
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
Homepage URL
asamoto-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-3815-5411
crctky-office@umin.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
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10877-019-00305-z
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10877-019-00305-z
Number of participants that the trial has enrolled
33
Results
Standard deviation of the average of 5-min normal-to-normal R-R intervals (SDANN) was significant lower than that of same-aged healthy volunteers (69.3 +- 27.9 vs. 137.0 +- 43.0 ms, P < 0.05), which indicated suppression of autonomic nervous system activity throughout their work.
Results date posted
| 2020 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese residents working in the Department of Anesthesia. We should note that residents in Japan were similar to interns in the United States; they were exclusively engaged in day-shift anesthesiology training for a certain period of time during an elective.
Participant flow
Institutional approval was obtained from the ethical committee of the University of Tokyo, Faculty of Medicine (Tokyo, Japan, #10699). This study was also registered to UMIN CTR (UMIN Clinical Trial Registry, Tokyo, Japan, #UMIN000019247).
Thirty-seven volunteers were recruited from 97 residents who worked in the Department of Anesthesiology in The University of Tokyo Hospital from January 2016 to March 2017. Informed consent was obtained from all individual participants included in the study.
Adverse events
None
Outcome measures
HRV analysis, POMS2 score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We published our results as an academic dissertation and research paper.
Management information
Registered date
| 2015 | Year | 10 | Month | 06 | Day |
Last modified on
| 2020 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022249
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| Registered date | File name |
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