Descriptive Study of Biological Stress and Perceived Stress at the Center 15

Psychological Stress Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075424
• Other study ID #: 2013-02-CHRMT
• Secondary ID: 2013-A01725-40
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: July 14, 2016
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Physiological Stress
• Psychological Stress
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Metz Thionville	Metz cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

References & Publications (5)

Hellhammer DH, Wüst S, Kudielka BM. Salivary cortisol as a biomarker in stress research. Psychoneuroendocrinology. 2009 Feb;34(2):163-71. doi: 10.1016/j.psyneuen.2008.10.026. Epub 2008 Dec 18. Review. — View Citation

Kirschbaum C, Hellhammer DH. Salivary cortisol in psychobiological research: an overview. Neuropsychobiology. 1989;22(3):150-69. Review. — View Citation

Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biological stress by salivary cortisol secretion		every 15 minutes after the emergency call and during 2 hours	No
Secondary	perceived stress : VAS and SPPN questionnaire	SPPN : Negative and Positive Professional Stress, before the first salivary sampling.; VAS : Visual Analogic Scale,	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)	No