NCT01367379

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

1.5 years

First QC Date

June 3, 2011

Last Update Submit

January 3, 2012

Conditions

Physiological StressPsychological Stress

Keywords

Physicianduty loadingstress responsePhysician with different amount of duty area

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Physician of internal medicine in Taipei city hospital

Procedure: 24 hour EKG and blood pressure monitorOther: Blood and urine sampling

Interventions

24 hour EKG and blood pressure monitorPROCEDURE

All subjects will have non-invasive 24 hour EKG and 24 hour EKG monitoring for 24 hours.

Physician of internal medicine in Taipei city hospital
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)

Physician of internal medicine in Taipei city hospital

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Attending physicians of internal medicine of Taipei municipal hospital, certified by Taiwan society of internal medicine.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan university hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalFractures, Stress

Interventions

Blood Pressure MonitorsBlood Specimen Collection

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and SuppliesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Yue Leon Guo, Professor

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiu Hao Lee, MD

CONTACT

886-2-25523234limax0809@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 7, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

TW(1)