Descriptive Study of Biological Stress and Perceived Stress at the Center 15 (RegulStress)

July 14, 2016 updated by: Centre Hospitalier Régional Metz-Thionville

Descriptive Study of Biological Stress and Perceived Stress in Call Regulation Operators and Doctors When Processing a Call at the Center 15

The purpose of this study is to describe biological stress (cortisolemia) and perceived stress in Emergency Call Center Operators and Doctors while processing a center 15 call.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sample description : qualitative variables be expressed as percentages, numbers and 95% confidence intervals Quantitative variables will be expressed as means, standard deviations or medians, range, interquartile intervals Description of biological stress : it will be described by calculating the difference between the observed peek or peeks of cortisol ans the cortisol level measured at rest (means, standard deviations or medians, range, interquartile intervals) Description of perceived stress : the AVS will be described in terms of means and standard deviation Comparison of the peek-delta/base level of cortisol in the 3 different workstations of the call center operators according to the non parametrical Kruskall Wallis test. Same for the lengthof service of the call operator, the severity of the call and the status of the doctor The AVS score (perceived stress) will be compared to the peek-delta/base level of cortisol (biological stress) thanks to the Spearmann correlation coefficient.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Metz cedex 03, France, 57085
        • Centre Hospitalier Regional Metz Thionville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical and paramedical staff from the center 15 (call operators, emergency doctors and general practitioners)
  • healthy volunteers having received the specific information letter regarding the sudy and having signed the clarified consent form
  • healthy volunteers are affiliated to the french social welfare

Exclusion Criteria:

  • chronic alcoholism
  • women under oestroprogestative hormonal treatment
  • high level athletes
  • healthy volunteers under steroids treatment
  • healthy volunteers suffering from a mental health related disorder
  • fever on the day the sample is taken
  • healthy volunteers with endocrine disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: salivery sampling by a biomnis swab

Each call operator will have a series of salivary sampling taken when assigned to call reception, to the unit deployment station and to the assessment station.

Only one sampling will occur to doctors who are assigned to a single workstation.

Sampling will be taken every 15 minutes during one hour and half and one last sample will be taken 2 hours after the call For each participant, a serie of control-samples will be taken during a day off and during a security break.
Other: salivary sampling by a biomnis swab

Each call operator will have a series of salivary sampling taken when assigned to call reception, to the unit deployment station and to the assessment station.

Only one sampling will occur to doctors who are assigned to a single workstation.

Sampling will be taken every 15 minutes during one hour and half and one last sample will be taken 2 hours after the call.

To improve interpretation of the results, a series of control-samples will be taken among the call operators and doctors during a day off and not during a security break.

There will be 4x8 samples taken for each call operator and 2x8 samples per doctor.

They will also be frozen at a temperature of -4°C and sent to the laboratory of the CHR Metz Thionville.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biological stress by salivary cortisol secretion
Time Frame: every 15 minutes after the emergency call and during 2 hours
every 15 minutes after the emergency call and during 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perceived stress : VAS and SPPN questionnaire
Time Frame: VAS is assessed four times (once after each emergency call) during the first salivary sampling. SPPN once, on day 1, remote the emergency call (within the hourspreceding or following the emergency call)

SPPN : Negative and Positive Professional Stress, before the first salivary sampling.

VAS : Visual Analogic Scale,
VAS is assessed four times (once after each emergency call) during the first salivary sampling. SPPN once, on day 1, remote the emergency call (within the hourspreceding or following the emergency call)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Michel Aussedat, MD, Centre Hospitalier Regional Metz-Thionville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-02-CHRMT
  • 2013-A01725-40 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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