Physiological StressRegulStressNCT02075424
Descriptive Study of Biological Stress and Perceived Stress at the Center 15
A study testing salivary sampling by a biomnis swab in people with Physiological Stress and Psychological Stress, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress, Psychological Stress
- What is being tested?
- salivary sampling by a biomnis swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physiological Stress, Psychological Stress
- Being tested
- salivary sampling by a biomnis swab
- Keywords
- stress, cortisol, emergency call center, hospital staff
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivary sampling by a biomnis swabOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: salivary sampling by a biomnis swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
biological stress by salivary cortisol secretion
Measured: every 15 minutes after the emergency call and during 2 hours
Secondary outcomes (1)
perceived stress : VAS and SPPN questionnaire
SPPN : Negative and Positive Professional Stress, before the first salivary sampling.
VAS : Visual Analogic Scale,
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Aussedat, MD, Principal investigator, Centre Hospitalier Régional Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075424
- Sponsor's protocol ID
- 2013-02-CHRMT
- Other IDs
- 2013-A01725-40
- Acronym
- RegulStress
- Status last verified
- Jul 2016
- First submitted
- 24 Feb 2014
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12658250Nakajima 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.
PubMed 22350686Kirschbaum C, Hellhammer DH. Salivary cortisol in psychobiological research: an overview. Neuropsychobiology. 1989;22(3):150-69. doi: 10.1159/000118611.
PubMed 2485862Hellhammer 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.
PubMed 19095358Kirschbaum 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.
PubMed 8047637Bedini S, Braun F, Weibel L, Aussedat M, Pereira B, Dutheil F. Stress and salivary cortisol in emergency medical dispatchers: A randomized shifts control trial. PLoS One. 2017 May 15;12(5):e0177094. doi: 10.1371/journal.pone.0177094. eCollection 2017.
PubMed 28505199
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Biological Stress and Perceived Stress in Call Regulation Operators and Doctors When Processing a Call at the Center 15
- ClinicalTrials.gov ID
- NCT02075424
- Acronym / sponsor ID
- RegulStress / 2013-02-CHRMT
- Conditions
- Physiological Stress, Psychological Stress
- Keywords
- stress, cortisol, emergency call center, hospital staff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| salivery sampling by a biomnis swab | Experimental | Other: salivary sampling by a biomnis swabEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- chronic alcoholism
- women under oestroprogestative hormonal treatment
- high level athletes
- healthy volunteers under steroids treatment
- healthy volunteers suffering from a mental health related disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salivary sampling by a biomnis swabEach 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. | Other | salivery sampling by a biomnis swab |
Primary outcome
biological stress by salivary cortisol secretion
Time frame: every 15 minutes after the emergency call and during 2 hours
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 12658250Weibel 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.
- Background: PubMed 22350686Nakajima 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.
- Background: PubMed 2485862Kirschbaum C, Hellhammer DH. Salivary cortisol in psychobiological research: an overview. Neuropsychobiology. 1989;22(3):150-69. doi: 10.1159/000118611.
- Background: PubMed 19095358Hellhammer 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.
- Background: PubMed 8047637Kirschbaum 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 publication: PubMed 28505199Bedini S, Braun F, Weibel L, Aussedat M, Pereira B, Dutheil F. Stress and salivary cortisol in emergency medical dispatchers: A randomized shifts control trial. PLoS One. 2017 May 15;12(5):e0177094. doi: 10.1371/journal.pone.0177094. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Aussedat, MD principal investigator
Centre Hospitalier Régional Metz-Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salivary sampling by a biomnis swab in people with Physiological Stress and Psychological Stress, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biological stress by salivary cortisol secretion (time frame: every 15 minutes after the emergency call and during 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075424, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.