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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Régional Metz-Thionville
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier:
NCT02075424
First received: February 24, 2014
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Physiological Stress
Psychological Stress
Other: salivary sampling by a biomnis swab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Descriptive Study of Biological Stress and Perceived Stress in Call Regulation Operators and Doctors When Processing a Call at the Center 15

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Régional Metz-Thionville:

Primary Outcome Measures:
  • biological stress by salivary cortisol secretion [ Time Frame: every 15 minutes after the emergency call and during 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

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

    VAS : Visual Analogic Scale,



Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02075424

Contacts
Contact: Michel Aussedat, MD +33 3 87 55 36 22 m.aussedat@chr-metz-thionville.fr
Contact: Sarah Bedini +33 7 77 28 28 36 sarah.bedini3@gmail.com

Locations
France
Centre Hospitalier Régional Metz Thionville Recruiting
Metz cedex 03, France, 57085
Contact: Michel Aussedat, MD    +33 3 87 55 36 22    m.aussedat@chr-metz-thionville.fr   
Contact: Sarah Bedini    + 33 7 77 28 28 36    sarah.bedini3@gmail.com   
Principal Investigator: Michel Aussedat         
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
Principal Investigator: Michel Aussedat, MD Centre Hospitalier Régional Metz-Thionville
  More Information

Publications:
Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT02075424     History of Changes
Other Study ID Numbers: 2013-02-CHRMT, 2013-A01725-40
Study First Received: February 24, 2014
Last Updated: March 12, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Régional Metz-Thionville:
stress
cortisol
emergency call center
hospital staff

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 29, 2014