The Effects of Stress on the Clinical Performance of Resi... | NCT00485927

Studies
The Effects of Stress on the Clinical Performance of Residents in Simulated Trauma Scenarios

NCT00485927

Sponsor

University of Toronto

Status

Unknown status

Last Update Posted

Jun 13, 2007Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Trauma
Stress

Interventions

stress

Countries

Canada

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

Jun 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 11, 2007

First Posted Date

Jun 13, 2007Estimated

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

Jun 11, 2007

Last Update Posted Date

Jun 13, 2007Estimated

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

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

Medical practice & training are inherently stressful situations. However, the effects of stress on educational & clinical performance are not well defined. The purpose of the current study is to examine the effects of stress on performance of residents in simulated trauma scenarios. The hypothesis is: 1) acutely stressful scenarios will be appraised as threat by residents and result in elevations of heart rate and salivary cortisol; 2) increased subjective & physiological stress will result in impairments in performance; and 3) greater stress responses will result in greater clinical impairments.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
stress	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
performance - global ratings
performance - ANTS
performance - checklists

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

University of Toronto General Surgery & Emergency medicine residents

Exclusion Criteria:

No ATLS training
Residents from other programs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adrian M Harvey, MD	Contact	416-340-4800	4306	adrian.harvey@utoronto.ca
Vicki Leblanc, PhD	Contact	416-340-3054		vicki.leblanc@utoronto.ca

Overall Officials

Name	Affiliation	Role
Adrian M Harvey, MD	University of Toronto, University Health Network	Principal Investigator
Avery B Nathans, MD, PhD	University of Toronto, St. Michael's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Michaels' Hospital	Recruiting	Toronto	Ontario	M5B 1W8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided