Descriptive Study of Biological Stress and Perceived Stress at the Center 15
RegulStress
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 18, 2016
July 1, 2016
2.3 years
February 24, 2014
July 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
biological stress by salivary cortisol secretion
every 15 minutes after the emergency call and during 2 hours
Secondary Outcomes (1)
perceived stress : VAS and SPPN questionnaire
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)
Study Arms (1)
salivery sampling by a biomnis swab
EXPERIMENTALEach 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Régional Metz Thionville
Metz, 57085, France
Related Publications (5)
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.
PMID: 12658250BACKGROUNDNakajima 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.
PMID: 22350686BACKGROUNDKirschbaum C, Hellhammer DH. Salivary cortisol in psychobiological research: an overview. Neuropsychobiology. 1989;22(3):150-69. doi: 10.1159/000118611.
PMID: 2485862BACKGROUNDHellhammer 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.
PMID: 19095358BACKGROUNDKirschbaum 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.
PMID: 8047637BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Aussedat, MD
Centre Hospitalier Régional Metz-Thionville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2014
First Posted
March 3, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 18, 2016
Record last verified: 2016-07