- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01367379
The Effect of the Duty Loading on the Stress Response of Physician
January 3, 2012 updated by: National Taiwan University Hospital
The investigators will study in the possibility of cardiovascular disease, caused by the duty loading, of physician of internal medicine.
The investigators will also explore if there {dose response effect} between the duty loading and the stress response of physicians of internal medicine.
Therefore, the investigators will compare the stress responses of physicians of internal medicine during with different duty loading ( non-duty day, one duty area with 3 wards, 2 duty areas with 6 wards) in a observational method.
Those stress response will be measured by cardiovascular risk indicators, including blood pressure, heart rate variability, blood sampling and urine sampling.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Hsiu Hao Lee, MD
- Phone Number: 5540 886-25523234
- Email: limax0809@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Attending physicians of internal medicine of Taipei municipal hospital, certified by Taiwan society of internal medicine.
We will compare those results of outcome variables of different amount of duty area.
Description
Inclusion Criteria:
- Attending physicians of internal medicine of Taipei municipal hospital, certified by Taiwan society of internal medicine.
Exclusion Criteria:
- thyroid dysfunction
- pregnancy, diabetes mellitus
- history of cardiovascular disease (stroke, coronary arterial disease, or myocardial infraction)
- current smokers, or
- taking sleeping pills or B-blocker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Physician of internal medicine in Taipei city hospital
|
All subjects will have non-invasive 24 hour EKG and 24 hour EKG monitoring for 24 hours.
Right before and after the duty loading, all subjects will have blood samplings, including CRP, WBC, IL-6, Fibrinogen, insulin, IL-6, Procalcitonin, TNF-alfa, catecholamine level.
Right after the duty loading, all subjects will have urine samplings for cortisol and catecholamine level.(blood
: 15CC/time and 2~4 times/month)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The physiological change of physician during different duty loadings
Time Frame: 4 months
|
The investigators will also explore if there {dose response effect} between the duty loading and the stress response of physicians of internal medicine, and will compare the stress responses of physicians of internal medicine during with different duty loading in a observational method.
Those stress response will be measured by cardiovascular risk indicators, including blood pressure, heart rate variability, blood sampling and urine sampling.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yue Leon Guo, Professor, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
June 3, 2011
First Submitted That Met QC Criteria
June 6, 2011
First Posted (Estimate)
June 7, 2011
Study Record Updates
Last Update Posted (Estimate)
January 5, 2012
Last Update Submitted That Met QC Criteria
January 3, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201104059RC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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