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CompletedNCT02853851PS-ICUUpdated Dec 31, 2024

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

An observational study in Work Stress, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
160
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Work Stress

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Keywords

  • Stress factors,
  • intensive care units,
  • scale,
  • quality of care
03

In context

Occupational Stress

240 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.

This study's enrollment of 160 is below the median of 200 across 65 observational studies indexed under Occupational Stress.

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Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 449 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Administrative staff, nursing auxiliaries

  • Senior physicians, interns, and nurses who have been working in the service for less than three months.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • Otherinterviews

    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).

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What researchers measure

Primary outcomes

  1. GENERATION OF ITEMS : Identifying the stress factors

    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:

    Time frame: up to 24 month

Secondary outcomes

  1. GENERATION OF ITEMS: Selecting the items

    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

    Time frame: up to 6 month

  2. GENERATION OF ITEMS: Administering the PS-ICU questionnaire

    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.

    Time frame: up to 24 month

  3. GENERATION OF ITEMS: Construction of the PS-ICU scale

    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.

    Time frame: up to 24 month

07

Study locations

1 site
  • CHU de Besançon
    Besançon, 25030, France
08

References and documents

Individual participant data

Plan to share: Yes — eCRF

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Feb 2021, 73 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2016
First posted
Aug 3, 2016
StartActual
Jan 1, 2015
Primary completionActual
Feb 18, 2021
CompletionActual
Feb 18, 2021
Last update
Dec 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02853851
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
Responsible party
Sponsor
First posted
Aug 3, 2016
Start date
Jan 1, 2015
Primary completion
Feb 18, 2021
Completion
Feb 18, 2021
Last update
Dec 31, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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