Nurses's WorkloadCHARMIREANCT05140473
Identification of the Determinants of the Perceived Workload of Nurses
An observational study of Nurses's Workload, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to identify the determinants of the perceived workload of intensive care and pediatric continuous monitoring nurses (factors liked to the care service, staff, patients treated) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nurses's Workload
- What is being tested?
- perceived workload
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 484 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2022to 2 Nov 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nurses works in Pediatric Intensive care and Continuous Monitoring Unit of the Necker Hospital, AP-HP, Paris Child hospitalized in the Intensive care and Continuous Monitoring Unit of the Necker Hospital, AP-HP, Paris
Who may be able to join
- Registered nurses from Pediatric Intensive care and Continuous Monitoring Unit agreeing to participate in the study,
- Having at least one patient in charge over the period considered
- Child regardless of age hospitalized in the Pediatric Intensive care and Continuous Monitoring unit.
- Non-opposition of the legal representative (s) to the collection of data
Who cannot join
- Nurse in job adaptation training
- Interim nurse
- Nurse not usually working in intensive care
- Reference nurses of the service
- Legal guardian of the child who doesn't speak or understand French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Determinants of the Perceived Workload of Intensive Care and Pediatric Continuous Monitoring Nurses
The purpose of this study is to identify the determinants of the perceived workload of intensive care and pediatric continuous monitoring nurses (factors liked to the care service, staff, patients treated)
Read the detailed description
In intensive care and pediatric continuous monitoring unit (RSCP), the workload of nurses (registered nurses) is high. It is important to distribute the workload correctly among caregivers in order to guarantee the quality and safety of care.
Workload can be measured by different means. The measure of the perceived workload has the advantage of taking into account not only the acts and care performed, but also the time pressure felt, the feeling of having been efficient in its task, the efforts made and the level of frustration felt.
Measuring the workload of RSCP registered nurses will help highlight the factors that may influence the workload. The aim is to allow an adequate distribution of patients between nurses, taking into account the determinants identified during this study.
Primary objective : Measure RSCP's nurses workload
Secondary objectives: Highlight the determinants of the overall perceived workload of RSCP nurses (organizational characteristics, of the individual, of the patient and of his entourage).
Highlight the determinants of each dimension of the perceived workload of RSCP nurses.
The calendar of data collection days will be defined by drawing lots. The day drawn for data collection will proceed normally, with no change in practice for nurses. A study investigator will inform the legal representative (s) of the possible data collection in their child that day and will trace their non-opposition in the medical file.
At the end of the day, registered nurses should collect data relating to family circles and individual characteristics. In addition, nurses must complete a NASA TLX grid for each patient treated during their working time. The grids will be assembled at the end of the day (around 7 p.m.) and handed over to an investigator. The same procedure will apply to the night shift, the grids will be handed over at 7 a.m. to an investigator.
In the following days, the principal investigator will collect the data related to the organizational characteristics and characteristics of the patients.
The perceived workload of nurses working in Intensive care and Continuous Monitoring Unit will be measured for each nurse who has at least 1 patient in charge during a period of 24 hours over 2 days (a day service and a night service, i.e. from 7 a.m. to 7 a.m. / D + 1 ), once a month for a year.
The measurement periods will be drawn at the rate of a period of 24 hours per month for one year, ie 12 periods in total.
- Conditions
- Nurses's Workload
- Being tested
- perceived workload
- Keywords
- Nurses, Workload, Intensive car unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perceived workloadBehavioural
Perceived workload takes into account the acts and care performed but also the pressure felt of having been efficient in its task, the efforts made and the level of frustration felt.
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Load indeX scale (TLX scale)
TLX scale is a workload scale according to 6 dimensions: mental demands, physical demands, time pressure, performance, effort and frustration.Each dimension is evaluated on a 100-points scale. A total score from 0 to 600 points is obtained. A higher score means a worse outcome.
Measured: 1 day
Secondary outcomes (24)
Seniority in the profession
Seniority in the profession in years Seniority in the service in years Age Previous patient management (at least once in the previous 12 months) Supervision of a student Tutoring a new nurse
Measured: 1 day
Seniority in the service
Seniority in the service in years Seniority in the service in years Age Previous patient management (at least once in the previous 12 months) Supervision of a student Tutoring a new nurse
Measured: 1 day
Age of nurse
Age of nurse in years Day / night work Number of patient transportations Reception of an incoming patient Participation in an ethics meeting
Measured: 1 day
Age of nurse
Age of nurse in years
Measured: 1 day
Previous patient management
Previous patient management (at least once in the previous 12 months)
Measured: 1 day
Supervision of a student
Supervision of a student (yes/no)
Measured: 1 day
Tutoring a new nurse
Tutoring a new nurse (yes/no)
Measured: 1 day
Ratio patient/nurse
Number of patient split by the number of nurse
Measured: 1 day
Period of work
Day / night work
Measured: 1 day
Patient transport
Number of patient transportations outside the ward.
Measured: 1 day
New patient
Reception of an incoming patient
Measured: 1 day
Ethics meeting
Participation of nurse to an ethics meeting
Measured: 1 day
Age of patient
Age of patient in years
Measured: 1 day
Weight of patient
Weight of patient in kilograms
Measured: 1 day
Lengh of Hospitalisation
Number of days in hospital
Measured: 1 day
Glasgow score
Glasgow score of patient. Scored on a total score from 3 to 15 points is obtained. A higher score means a better outcome.
Measured: 1 day
Vascular supply
Type of vascular catheter present on the patient
Measured: 1 day
Supportive system
Number of supportive systems necessary
Measured: 1 day
Treatment
Number of treatments administered / 24 hours
Measured: 1 day
Resuscitation maneuver
Resuscitation maneuver necessary (yes/no)
Measured: 1 day
Death
Death of patient (yes/no)
Measured: 1 day
Family support
Number of hours of presence of at least one of the two parents
Measured: 1 day
Phone calls
Number of phone calls from parents
Measured: 1 day
Family interview
Family interview realised ( Yes/No)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start20 Jun 2022
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nurses's WorkloadStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sophie CRETE, BSc nursing, Principal investigator, Assistance Public-Hôpitaux de ParisMedhi OUALHA, MD, PhD, Study chair, Assistance Public-Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140473
- Sponsor's protocol ID
- APHP211025
- Other IDs
- 2021-A01542-39
- Acronym
- CHARMIREA
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lebet RM, Hasbani NR, Sisko MT, Agus MSD, Nadkarni VM, Wypij D, Curley MAQ. Nurses' Perceptions of Workload Burden in Pediatric Critical Care. Am J Crit Care. 2021 Jan 1;30(1):27-35. doi: 10.4037/ajcc2021725.
PubMed 33385203Helmreich RL. On error management: lessons from aviation. BMJ. 2000 Mar 18;320(7237):781-5. doi: 10.1136/bmj.320.7237.781. No abstract available.
PubMed 10720367Llenore E, Ogle KR. Nurse-patient communication in the intensive care unit: a review of the literature. Aust Crit Care. 1999 Dec;12(4):142-5. doi: 10.1016/s1036-7314(99)70599-0.
PubMed 11271028Gurses AP, Carayon P, Wall M. Impact of performance obstacles on intensive care nurses' workload, perceived quality and safety of care, and quality of working life. Health Serv Res. 2009 Apr;44(2 Pt 1):422-43. doi: 10.1111/j.1475-6773.2008.00934.x. Epub 2008 Dec 16.
PubMed 19207589Nasirizad Moghadam K, Chehrzad MM, Reza Masouleh S, Maleki M, Mardani A, Atharyan S, Harding C. Nursing physical workload and mental workload in intensive care units: Are they related? Nurs Open. 2021 Jul;8(4):1625-1633. doi: 10.1002/nop2.785. Epub 2021 Feb 17.
PubMed 33596333Young G, Zavelina L, Hooper V. Assessment of workload using NASA Task Load Index in perianesthesia nursing. J Perianesth Nurs. 2008 Apr;23(2):102-10. doi: 10.1016/j.jopan.2008.01.008.
PubMed 18362006Tubbs-Cooley HL, Mara CA, Carle AC, Gurses AP. The NASA Task Load Index as a measure of overall workload among neonatal, paediatric and adult intensive care nurses. Intensive Crit Care Nurs. 2018 Jun;46:64-69. doi: 10.1016/j.iccn.2018.01.004. Epub 2018 Feb 12.
PubMed 29449130
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Determinants of the Perceived Workload of Intensive Care and Pediatric Continuous Monitoring Nurses
- ClinicalTrials.gov ID
- NCT05140473
- Acronym / sponsor ID
- CHARMIREA / APHP211025
- Conditions
- Nurses's Workload
- Keywords
- Nurses, Workload, Intensive car unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- 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.
The purpose of this study is to identify the determinants of the perceived workload of intensive care and pediatric continuous monitoring nurses (factors liked to the care service, staff, patients treated)
Detailed description
In intensive care and pediatric continuous monitoring unit (RSCP), the workload of nurses (registered nurses) is high. It is important to distribute the workload correctly among caregivers in order to guarantee the quality and safety of care.
Workload can be measured by different means. The measure of the perceived workload has the advantage of taking into account not only the acts and care performed, but also the time pressure felt, the feeling of having been efficient in its task, the efforts made and the level of frustration felt.
Measuring the workload of RSCP registered nurses will help highlight the factors that may influence the workload. The aim is to allow an adequate distribution of patients between nurses, taking into account the determinants identified during this study.
Primary objective : Measure RSCP's nurses workload
Secondary objectives: Highlight the determinants of the overall perceived workload of RSCP nurses (organizational characteristics, of the individual, of the patient and of his entourage).
Highlight the determinants of each dimension of the perceived workload of RSCP nurses.
The calendar of data collection days will be defined by drawing lots. The day drawn for data collection will proceed normally, with no change in practice for nurses. A study investigator will inform the legal representative (s) of the possible data collection in their child that day and will trace their non-opposition in the medical file.
At the end of the day, registered nurses should collect data relating to family circles and individual characteristics. In addition, nurses must complete a NASA TLX grid for each patient treated during their working time. The grids will be assembled at the end of the day (around 7 p.m.) and handed over to an investigator. The same procedure will apply to the night shift, the grids will be handed over at 7 a.m. to an investigator.
In the following days, the principal investigator will collect the data related to the organizational characteristics and characteristics of the patients.
The perceived workload of nurses working in Intensive care and Continuous Monitoring Unit will be measured for each nurse who has at least 1 patient in charge during a period of 24 hours over 2 days (a day service and a night service, i.e. from 7 a.m. to 7 a.m. / D + 1 ), once a month for a year.
The measurement periods will be drawn at the rate of a period of 24 hours per month for one year, ie 12 periods in total.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nurses works in Pediatric Intensive care and Continuous Monitoring Unit of the Necker Hospital, AP-HP, Paris Child hospitalized in the Intensive care and Continuous Monitoring Unit of the Necker Hospital, AP-HP, Paris
Key inclusion criteria (4 listed)
- Registered nurses from Pediatric Intensive care and Continuous Monitoring Unit agreeing to participate in the study,
- Having at least one patient in charge over the period considered
- Child regardless of age hospitalized in the Pediatric Intensive care and Continuous Monitoring unit.
- Non-opposition of the legal representative (s) to the collection of data
Key exclusion criteria (5 listed)
- Nurse in job adaptation training
- Interim nurse
- Nurse not usually working in intensive care
- Reference nurses of the service
- Legal guardian of the child who doesn't speak or understand French
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 |
|---|---|---|
| perceived workloadPerceived workload takes into account the acts and care performed but also the pressure felt of having been efficient in its task, the efforts made and the level of frustration felt. | Behavioural | – |
Primary outcome
Task Load indeX scale (TLX scale)
Time frame: 1 day
TLX scale is a workload scale according to 6 dimensions: mental demands, physical demands, time pressure, performance, effort and frustration.Each dimension is evaluated on a 100-points scale. A total score from 0 to 600 points is obtained. A higher score means a worse outcome.
24 secondary outcomes
Seniority in the profession
Time frame: 1 day
Seniority in the service
Time frame: 1 day
Age of nurse
Time frame: 1 day
Age of nurse
Time frame: 1 day
Previous patient management
Time frame: 1 day
Supervision of a student
Time frame: 1 day
Tutoring a new nurse
Time frame: 1 day
Ratio patient/nurse
Time frame: 1 day
Period of work
Time frame: 1 day
Patient transport
Time frame: 1 day
New patient
Time frame: 1 day
Ethics meeting
Time frame: 1 day
Age of patient
Time frame: 1 day
Weight of patient
Time frame: 1 day
Lengh of Hospitalisation
Time frame: 1 day
Glasgow score
Time frame: 1 day
Vascular supply
Time frame: 1 day
Supportive system
Time frame: 1 day
Treatment
Time frame: 1 day
Resuscitation maneuver
Time frame: 1 day
Death
Time frame: 1 day
Family support
Time frame: 1 day
Phone calls
Time frame: 1 day
Family interview
Time frame: 1 day
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 30 Mar 2026.
- Background: PubMed 33385203Lebet RM, Hasbani NR, Sisko MT, Agus MSD, Nadkarni VM, Wypij D, Curley MAQ. Nurses' Perceptions of Workload Burden in Pediatric Critical Care. Am J Crit Care. 2021 Jan 1;30(1):27-35. doi: 10.4037/ajcc2021725.
- Background: PubMed 10720367Helmreich RL. On error management: lessons from aviation. BMJ. 2000 Mar 18;320(7237):781-5. doi: 10.1136/bmj.320.7237.781. No abstract available.
- Background: PubMed 11271028Llenore E, Ogle KR. Nurse-patient communication in the intensive care unit: a review of the literature. Aust Crit Care. 1999 Dec;12(4):142-5. doi: 10.1016/s1036-7314(99)70599-0.
- Background: PubMed 19207589Gurses AP, Carayon P, Wall M. Impact of performance obstacles on intensive care nurses' workload, perceived quality and safety of care, and quality of working life. Health Serv Res. 2009 Apr;44(2 Pt 1):422-43. doi: 10.1111/j.1475-6773.2008.00934.x. Epub 2008 Dec 16.
- Background: PubMed 33596333Nasirizad Moghadam K, Chehrzad MM, Reza Masouleh S, Maleki M, Mardani A, Atharyan S, Harding C. Nursing physical workload and mental workload in intensive care units: Are they related? Nurs Open. 2021 Jul;8(4):1625-1633. doi: 10.1002/nop2.785. Epub 2021 Feb 17.
- Background: PubMed 18362006Young G, Zavelina L, Hooper V. Assessment of workload using NASA Task Load Index in perianesthesia nursing. J Perianesth Nurs. 2008 Apr;23(2):102-10. doi: 10.1016/j.jopan.2008.01.008.
- Background: PubMed 29449130Tubbs-Cooley HL, Mara CA, Carle AC, Gurses AP. The NASA Task Load Index as a measure of overall workload among neonatal, paediatric and adult intensive care nurses. Intensive Crit Care Nurs. 2018 Jun;46:64-69. doi: 10.1016/j.iccn.2018.01.004. Epub 2018 Feb 12.
- Individual participant dataSharing planned: No
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.
Sophie CRETE, BSc nursing principal investigator
Assistance Public-Hôpitaux de Paris
Medhi OUALHA, MD, PhD study chair
Assistance Public-Hôpitaux de Paris
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 Nurses's Workload, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 5 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 30 Mar 2026. 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?
Task Load indeX scale (TLX scale) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05140473, which also lists 7 linked publications.
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 30 Mar 2026.