The Effect of the Duty Loading on the Stress Response of Physician

Psychological Stress Clinical Trial

Official title:

The Effect of the Duty Loading on the Stress Response of Physician

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01367379
• Other study ID #: 201104059RC
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2011
• Last updated: January 3, 2012
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: National Taiwan University Hospital
• Contact: Hsiu Hao Lee, MD
• Phone: 886-2-25523234
• Email: limax0809[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Physiological Stress
• Psychological Stress
• Stress, Psychological

Intervention

Procedure:
• 24 hour EKG and blood pressure monitor
All subjects will have non-invasive 24 hour EKG and 24 hour EKG monitoring for 24 hours.

Other:
• Blood and urine sampling
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)

Locations

Country	Name	City	State
Taiwan	National Taiwan university hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months	No