Work StressPS-ICUNCT02853851
Construction and Validation of a Stress Scale Specific to ICUs: Perceived Stressors in Intensive Care Units (PS-ICU)
An observational study of Work Stress, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Work Stress
- What is being tested?
- interviews
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 18 Feb 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Administrative staff, nursing auxiliaries
- Senior physicians, interns, and nurses who have been working in the service for less than three months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Work Stress
- Being tested
- interviews
- Keywords
- Stress factors,, intensive care units,, scale,, quality of care
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: up to 24 month
Secondary outcomes (3)
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
Measured: up to 6 month
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.
Measured: up to 24 month
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.
Measured: up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start1 Jan 2015
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853851
- Sponsor's protocol ID
- API/2014/56
- Acronym
- PS-ICU
- Status last verified
- Dec 2024
- First submitted
- 20 Jul 2016
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: eCRF
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Stress Scale Specific to ICUs: Perceived Stressors in Intensive Care Units (PS-ICU)
- ClinicalTrials.gov ID
- NCT02853851
- Acronym / sponsor ID
- PS-ICU / API/2014/56
- Conditions
- Work Stress
- Keywords
- Stress factors,, intensive care units,, scale,, quality of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- 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
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 3 Aug 2016 (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.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| France | – | Other: interviews10 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) |
| Italy | – | Other: interviews10 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) |
| spain | – | Other: interviews10 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) |
| montreal | – | Other: interviews10 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- In this step, we will include the services which:
- 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.
Key exclusion criteria (2 listed)
- Administrative staff, nursing auxiliaries
- Senior physicians, interns, and nurses who have been working in the service for less than three months.
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 |
|---|---|---|
| interviewsEach 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). | Other | France, Italy, montreal, spain |
Primary outcome
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:
3 secondary outcomes
GENERATION OF ITEMS: Selecting the items
Time frame: up to 6 month
GENERATION OF ITEMS: Administering the PS-ICU questionnaire
Time frame: up to 24 month
GENERATION OF ITEMS: Construction of the PS-ICU scale
Time frame: up to 24 month
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 31 Dec 2024.
- Individual participant dataSharing planned: Yes. eCRF
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work Stress, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 2 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 31 Dec 2024. 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?
GENERATION OF ITEMS : Identifying the stress factors (time frame: up to 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.