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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02075424
First Posted: March 3, 2014
Last Update Posted: July 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville
February 24, 2014
March 3, 2014
July 18, 2016
March 2014
June 2016   (Final data collection date for primary outcome measure)
biological stress by salivary cortisol secretion [ Time Frame: every 15 minutes after the emergency call and during 2 hours ]
Same as current
Complete list of historical versions of study NCT02075424 on ClinicalTrials.gov Archive Site
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,

Same as current
Not Provided
Not Provided
 
Descriptive Study of Biological Stress and Perceived Stress at the Center 15
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Physiological Stress
  • Psychological Stress
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.

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.

Intervention: Other: salivary sampling by a biomnis swab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02075424
2013-02-CHRMT
2013-A01725-40 ( Other Identifier: ANSM )
No
Not Provided
Not Provided
Centre Hospitalier Régional Metz-Thionville
Centre Hospitalier Régional Metz-Thionville
Not Provided
Principal Investigator: Michel Aussedat, MD Centre Hospitalier Régional Metz-Thionville
Centre Hospitalier Régional Metz-Thionville
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP