Subjective Feelings of Job Stress and Frontal Activity Du... | NCT02286180

Studies
Subjective Feelings of Job Stress and Frontal Activity During Verbal Fluency Test: A Near-infrared Spectroscopy Study

NCT02286180

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Nov 11, 2014Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Stress

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Nov 4, 2014

First Submission Date that Met QC Criteria

Nov 6, 2014

First Posted Date

Nov 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background and objectives:

Recently the news of intern doctors' death due to overloaded work or committing suicide has made the authorities concerned put emphasis on the mental health care of medical staffs and related policies of psychological interventions. The prefrontal lobe plays an important role in the working memory, executive function and problem-solving abilities of the brain. Currently, no neuroimaging studies investigating the impact of job stress on the prefrontal love functions in intern doctors. Functional near-infrared spectroscopy (fNIRS) measures the cortical functions of the frontotemporal regions and has been widely used as a biomarker to aid in differential diagnoses in major psychiatric illnesses in Japan. The present study will investigate impact of the job stress on brain cortical activity during a verbal fluency test (VFT) by using fNIRS.

Materials and methods:

A total of 100 participants will be recruited. Clinical measurements of mood status by Beck's Depression Inventory and Beck's Anxiety Inventory, as well as job stress by Chinese Version of the Job Content Questionnaire and the Chinese version of Copenhagen Burnout Inventory will be arranged. The relationship between clinical measurements and cortical activity during a VFT will be analyzed by Pearson's correlation. Multiple regression analysis will be applied to investigate the independent contributions of mood status and job stress.

Expected results and contributions of the study:

Job stress, depression, and anxiety are significantly negatively correlated with cortical activity of prefrontal regions. The importance of mental health of medical staffs under high job stress should be stressed.

Detailed Description

A total of 100 intern doctors will be recruited. The data including Chinese version of Copenhagen burnout inventory, BDI, BAI, average working hours per day, and average sleeping times were acquired. They will undergo NIRS investigations to detect frontal activities during performing a verbal fluency test. The correlation between stress parameters and cortical activities were examined.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
frontal cortical activities during cognitive test detecting by near infrared spectroscopy		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

medical intern doctors who are willing to participate in the study.

Exclusion Criteria:

with past psychiatric disease
with history substance abuse or dependence
with history neurological disorders or head trauma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Medical Intern Doctors in a medical center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PoHan Chou, MD	Taichung Veterans General Hospital, Taiwan, ROC.	Principal Investigator

Locations

Not provided