Descriptive Study of Biological Stress and Perceived Stress at the Center 15 (RegulStress)
Primary Purpose
Physiological Stress, Psychological Stress
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
salivary sampling by a biomnis swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Physiological Stress focused on measuring stress, cortisol, emergency call center, hospital staff
Eligibility 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
Sites / Locations
- Centre Hospitalier Régional Metz Thionville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
salivery sampling by a biomnis swab
Arm Description
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.
Outcomes
Primary Outcome Measures
biological stress by salivary cortisol secretion
Secondary Outcome Measures
perceived stress : VAS and SPPN questionnaire
SPPN : Negative and Positive Professional Stress, before the first salivary sampling.
VAS : Visual Analogic Scale,
Full Information
NCT ID
NCT02075424
First Posted
February 24, 2014
Last Updated
July 14, 2016
Sponsor
Centre Hospitalier Régional Metz-Thionville
1. Study Identification
Unique Protocol Identification Number
NCT02075424
Brief Title
Descriptive Study of Biological Stress and Perceived Stress at the Center 15
Acronym
RegulStress
Official Title
Descriptive Study of Biological Stress and Perceived Stress in Call Regulation Operators and Doctors When Processing a Call at the Center 15
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiological Stress, Psychological Stress
Keywords
stress, cortisol, emergency call center, hospital staff
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
salivery sampling by a biomnis swab
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
salivary sampling by a biomnis swab
Intervention Description
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.
Primary Outcome Measure Information:
Title
biological stress by salivary cortisol secretion
Time Frame
every 15 minutes after the emergency call and during 2 hours
Secondary Outcome Measure Information:
Title
perceived stress : VAS and SPPN questionnaire
Description
SPPN : Negative and Positive Professional Stress, before the first salivary sampling.
VAS : Visual Analogic Scale,
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Aussedat, MD
Organizational Affiliation
Centre Hospitalier Régional Metz-Thionville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Metz Thionville
City
Metz cedex 03
ZIP/Postal Code
57085
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
12658250
Citation
Weibel L, Gabrion I, Aussedat M, Kreutz G. Work-related stress in an emergency medical dispatch center. Ann Emerg Med. 2003 Apr;41(4):500-6. doi: 10.1067/mem.2003.109.
Results Reference
background
PubMed Identifier
22350686
Citation
Nakajima Y, Takahashi T, Shetty V, Yamaguchi M. Patterns of salivary cortisol levels can manifest work stress in emergency care providers. J Physiol Sci. 2012 May;62(3):191-7. doi: 10.1007/s12576-012-0197-8. Epub 2012 Feb 19.
Results Reference
background
PubMed Identifier
2485862
Citation
Kirschbaum C, Hellhammer DH. Salivary cortisol in psychobiological research: an overview. Neuropsychobiology. 1989;22(3):150-69. doi: 10.1159/000118611.
Results Reference
background
PubMed Identifier
19095358
Citation
Hellhammer DH, Wust S, Kudielka BM. Salivary cortisol as a biomarker in stress research. Psychoneuroendocrinology. 2009 Feb;34(2):163-171. doi: 10.1016/j.psyneuen.2008.10.026. Epub 2008 Dec 18.
Results Reference
background
PubMed Identifier
8047637
Citation
Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. doi: 10.1016/0306-4530(94)90013-2.
Results Reference
background
Learn more about this trial
Descriptive Study of Biological Stress and Perceived Stress at the Center 15
We'll reach out to this number within 24 hrs