NCT02075424

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

February 24, 2014

Last Update Submit

July 14, 2016

Conditions

Keywords

stresscortisolemergency call centerhospital staff

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

EXPERIMENTAL

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

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.

salivery sampling by a biomnis swab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 12658250BACKGROUND
  • 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.

    PMID: 22350686BACKGROUND
  • Kirschbaum C, Hellhammer DH. Salivary cortisol in psychobiological research: an overview. Neuropsychobiology. 1989;22(3):150-69. doi: 10.1159/000118611.

    PMID: 2485862BACKGROUND
  • 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.

    PMID: 19095358BACKGROUND
  • 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.

    PMID: 8047637BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Michel Aussedat, MD

    Centre Hospitalier Régional Metz-Thionville

    PRINCIPAL INVESTIGATOR

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

Locations