NCT02853851

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2021

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

6.1 years

First QC Date

July 20, 2016

Last Update Submit

December 27, 2024

Conditions

Keywords

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

Outcome Measures

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:

    up to 24 month

Secondary Outcomes (3)

  • GENERATION OF ITEMS: Selecting the items

    up to 6 month

  • GENERATION OF ITEMS: Administering the PS-ICU questionnaire

    up to 24 month

  • GENERATION OF ITEMS: Construction of the PS-ICU scale

    up to 24 month

Study Arms (4)

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

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).

FranceItalymontrealspain

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Occupational Stress

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

August 3, 2016

Study Start

January 1, 2015

Primary Completion

February 18, 2021

Study Completion

February 18, 2021

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

eCRF

Locations