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Construction and Validation of a Stress Scale Specific to ICUs: Perceived Stressors in Intensive Care Units (PS-ICU) (PS-ICU)

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ClinicalTrials.gov Identifier: NCT02853851
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborators:
Laboratoire de psychologie université de franche Comté
Unité de méthodologie et de qualité de vie en cancérologie CHU de besançon
Hospital de Sabadell Department of Critical Care Spain
Policlinico A. Gemelli Department of Critical Care Italy
Centre hospitalier de l'Université de Montréal (CHUM)
Alfred Hospital Intensive Care Unit Australia
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
This study aims to construct and validate an international professional perceived stress scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive Care Units).

Condition or disease Intervention/treatment
Work Stress Other: interviews

Detailed Description:

Intensive care units take charge of patients who present serious pathological states with an immediate vital risk in an emergency situation. Their treatment requires extensive coordination of human means and sometimes the use of complex procedures and technical means. Moreover, caregivers face the extreme situations of patients and their families coping with death, illness, pain and uncertainty (Weibel et al., 2003).

In this context, numerous stress factors that can have psychological consequences on the professionals and their effectiveness at work are inherent in intensive care (Donchin, 2002; Tummers et al., 2002).

In numerous studies, perceived stress proves to be more predictive of the subsequent health state of the individual than real stress (Consoli et al., 2001). More precisely, the authors have shown the influence of perceived stress on mental health (Ramirez et al., 1996b), psychical health (Chang et al., 2007), burnout (Bourbonnais et al., 1999), job dissatisfaction (Golbasi et al., 2008), absenteeism (Hackett & Bycio, 1996), turnover (Hayes et al., 2006) and more recently on the security of care (Endacott, 2012).

Identifying the factors of perceived stress is important in terms of mental health at work and the security of care. Studies on perceived stress have made it possible to elaborate stress scales specific to each profession (Borteyrou et al., 2013), with the aim of being as close as possible to the professionals' experience. However, to our knowledge, no stress scale for intensive care units has been published.

This study aims to construct and validate an international professional perceived stress scale specific to intensive care units: the PS-ICU Scale (Perceived Stressors in Intensive Care Units). Secondary objectives: To identify the factors of perceived stress having an impact on mental health, job satisfaction and the quality of care. To measure the impact of cultural and organizational dimensions on perceived stress in intensive care specific to each country. To measure the impact of socio-demographic variables on perceived stress. To measure the impact of coping abilities on perceived stress.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Construction and Validation of a Stress Scale Specific to ICUs: Perceived Stressors in Intensive Care Units (PS-ICU)
Study Start Date : January 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2018

Group/Cohort Intervention/treatment
France
10 senior physicians, 10 interns, 10 experienced nurses (with more than one year of experience in the service) and 10 inexperienced nurses (with less than one year of experience in the service)
Other: interviews
Each subject will be asked to participate in an individual semidirective interview lasting about 40 minutes on the theme of the stress factors encountered in intensive care. All of the interviews will be audio-taped, transcribed and anonymized. The participants will also have to answer a socio-demographic questionnaire (sex, age, socio-professional category, speciality in intensive care, working hours, family situation, training, diplomas, length of time in the service).

Italy
10 senior physicians, 10 interns, 10 experienced nurses (with more than one year of experience in the service) and 10 inexperienced nurses (with less than one year of experience in the service)
Other: interviews
Each subject will be asked to participate in an individual semidirective interview lasting about 40 minutes on the theme of the stress factors encountered in intensive care. All of the interviews will be audio-taped, transcribed and anonymized. The participants will also have to answer a socio-demographic questionnaire (sex, age, socio-professional category, speciality in intensive care, working hours, family situation, training, diplomas, length of time in the service).

spain
10 senior physicians, 10 interns, 10 experienced nurses (with more than one year of experience in the service) and 10 inexperienced nurses (with less than one year of experience in the service)
Other: interviews
Each subject will be asked to participate in an individual semidirective interview lasting about 40 minutes on the theme of the stress factors encountered in intensive care. All of the interviews will be audio-taped, transcribed and anonymized. The participants will also have to answer a socio-demographic questionnaire (sex, age, socio-professional category, speciality in intensive care, working hours, family situation, training, diplomas, length of time in the service).

montreal
10 senior physicians, 10 interns, 10 experienced nurses (with more than one year of experience in the service) and 10 inexperienced nurses (with less than one year of experience in the service)
Other: interviews
Each subject will be asked to participate in an individual semidirective interview lasting about 40 minutes on the theme of the stress factors encountered in intensive care. All of the interviews will be audio-taped, transcribed and anonymized. The participants will also have to answer a socio-demographic questionnaire (sex, age, socio-professional category, speciality in intensive care, working hours, family situation, training, diplomas, length of time in the service).




Primary Outcome Measures :
  1. GENERATION OF ITEMS : Identifying the stress factors [ Time Frame: up to 24 month ]
    In order to construct a first questionnaire based on all of the factors of perceived stress in intensive care, our research team will begin by identifying the stress factors. This identification will involve two main sources:


Secondary Outcome Measures :
  1. GENERATION OF ITEMS: Selecting the items [ Time Frame: up to 6 month ]
    All of the stress factors identified in the literature and in the exploratory interviews will then be grouped and organized according to the different dimensions of stress identified in health psychology

  2. GENERATION OF ITEMS: Administering the PS-ICU questionnaire [ Time Frame: up to 24 month ]
    The PS-ICU Questionnaire will be administered to a representative population (doctors and nurses in intensive care) in each of the countries involved. This population will allow us to do the analyses necessary for the reduction of the items, and to retain only the most reliable items. The administration of the questionnaire will also be used to evaluate several aspects: pertinence, comprehension, and redundancy of the items.

  3. GENERATION OF ITEMS: Construction of the PS-ICU scale [ Time Frame: up to 24 month ]
    Our research team will collect all of the quantitative data gathered in the framework of administering the PS-ICU questionnaire (France, Spain, Italia, Canada, Australia). It will be in charge of the statistical analysis and the interpretation of the results.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The exploratory interviews will be conducted first in France. The French population will serve as the reference corpus, therefore the saturation threshold of the French reference corpus will determine the size of the corpus of the other countries (see the following section "analysis of the data").

In each country, 10 senior physicians, 10 interns, 10 experienced nurses (with more than one year of experience in the service) and 10 inexperienced nurses (with less than one year of experience in the service) will be solicited for an exploratory interview.

Criteria

Inclusion Criteria:

  • In this step, we will include the services which:

    • Practise an activity of intensive care (whether this practice is medical or surgical, adult or paediatric).

The professionals of ICU who:

  • volunteer to participate in the study (and with the consent of the head of the unit),
  • Senior physicians, interns, and nurses who have been working in the service for more than three months.

Exclusion Criteria:

Administrative staff, nursing auxiliaries

  • Senior physicians, interns, and nurses who have been working in the service for less than three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853851


Contacts
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Contact: Gilles CAPELLIER, PU-PH gilles.capellier@univ-fcomte.fr
Contact: Alexandra Laurent alexandra.laurent@univ-fcomte.fr

Locations
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France
CHU de Besançon Recruiting
Besançon, France, 25030
Contact: Gilles CAPELLIER       gilles.capellier@univ-fcomte.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Laboratoire de psychologie université de franche Comté
Unité de méthodologie et de qualité de vie en cancérologie CHU de besançon
Hospital de Sabadell Department of Critical Care Spain
Policlinico A. Gemelli Department of Critical Care Italy
Centre hospitalier de l'Université de Montréal (CHUM)
Alfred Hospital Intensive Care Unit Australia
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02853851    
Other Study ID Numbers: API/2014/56
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: eCRF
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Stress factors,
intensive care units,
scale,
quality of care
Additional relevant MeSH terms:
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Occupational Stress
Occupational Diseases
Stress, Psychological
Behavioral Symptoms