Physiological StressNCT01367379
The Effect of the Duty Loading on the Stress Response of Physician
An observational study of Physiological Stress and Psychological Stress, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress, Psychological Stress
- What is being tested?
- 24 hour EKG and blood pressure monitor and Blood and urine sampling
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Attending physicians of internal medicine of Taipei municipal hospital, certified by Taiwan society of internal medicine.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan university hospital
Taipei, 100
Hsiu Hao Lee, MD, 886-25523234 ext. 5540, limax0809@gmail.com
About this study
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.
- Conditions
- Physiological Stress, Psychological Stress
- Being tested
- 24 hour EKG and blood pressure monitor, Blood and urine sampling
- Keywords
- Physician, duty loading, stress response, Physician with different amount of duty area
- Medical subject headings
- Stress, Psychological, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hour EKG and blood pressure monitorProcedure or surgery
All subjects will have non-invasive 24 hour EKG and 24 hour EKG monitoring for 24 hours.
Blood and urine samplingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Physician of internal medicine in Taipei city hospital | Not described Receives: Procedure: 24 hour EKG and blood pressure monitor; Other: Blood and urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The physiological change of physician during different duty loadings
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei City Hospital
- Responsible party
- Sponsor
- Investigators
- Yue Leon Guo, Professor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367379
- Sponsor's protocol ID
- 201104059RC
- Status last verified
- Jan 2012
- First submitted
- 3 Jun 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Duty Loading on the Stress Response of Physician
- ClinicalTrials.gov ID
- NCT01367379
- Acronym / sponsor ID
- 201104059RC
- Conditions
- Physiological Stress, Psychological Stress
- Keywords
- Physician, duty loading, stress response, Physician with different amount of duty area
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei City Hospital
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physician of internal medicine in Taipei city hospital | – | Procedure: 24 hour EKG and blood pressure monitor, Other: Blood and urine sampling |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Attending physicians of internal medicine of Taipei municipal hospital, certified by Taiwan society of internal medicine.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 hour EKG and blood pressure monitorAll subjects will have non-invasive 24 hour EKG and 24 hour EKG monitoring for 24 hours. | Procedure or surgery | Physician of internal medicine in Taipei city hospital |
| Blood and urine samplingRight 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) | Other | Physician of internal medicine in Taipei city hospital |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yue Leon Guo, Professor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiological Stress and Psychological Stress, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiu Hao Lee, MD (886-2-25523234 ext. 5540, limax0809@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The physiological change of physician during different duty loadings (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012; AzTrials last refreshed its copy on 6 Nov 2026.