Pedagogical and Psycho-social Impact of in Situ SimulationImpact-SUrVISNCT05247580
Impact of Pediatric Medical Emergencies' in Situ Simulations
An observational study of Pedagogical and Psycho-social Impact of in Situ Simulation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Simulation in healthcare is becoming more and more essential in the training of paramedical and medical caregivers. It is a powerful educational tool that can enrich knowledge and skills, whether technical (setting up a venous catheter, intubation, etc...) or transversal (teamwork, communication, stress management in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pedagogical and Psycho-social Impact of in Situ Simulation
- What is being tested?
- Hicks self-confidence scale, Karasek survey, Maslach Burnout Inventory
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- May 2024to Nov 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caregivers staff at Necker - Enfants Malades Hospital
Who may be able to join
- Any caregivers staff at Necker - Enfants Malades Hospital agreeing to participate in the Impact-SUrVIS study and thoroughly complete the Impact-SUrVIS study questionnaires.
- Non-medical staff at Necker - Enfants Malades Hospital:
- Attending nurses
- Attending nurses' aides
- Student nurse
- Student nurses' aides
Show all 9Show fewer
- Medical staff at Necker - Enfants Malades Hospital:
- Doctor of Medicine (M.D.)
- Pediatrics, Emergency Medicine and Anesthesia/Intensive care Residents.
Who cannot join
- Medical student
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Assessment of an Interdisciplinary and Multimodal Hospital Program of Pediatric Medical Emergencies' in Situ Simulation
Simulation in healthcare is becoming more and more essential in the training of paramedical and medical caregivers. It is a powerful educational tool that can enrich knowledge and skills, whether technical (setting up a venous catheter, intubation, etc...) or transversal (teamwork, communication, stress management in crises, etc.).
The hospital environment requires nurses, nurses' aides, residents, and doctors to provide human care in increasingly technical work environments while exercising increasing responsibilities. These caregivers are therefore exposed to many stressors. Several studies highlight the benefits of simulation on the ability of professionals to deal with rare and/or complex crises which they have previously faced during simulation sessions.
Read more
Beginning January 2022, the Necker - Enfants Malades hospital will start a hospital' scale training program for pediatric medical emergencies using in situ simulation of the Necker - Enfants Malades hospital.
The SUrVIS (Simulation d'Urgences Vitales In Situ) project is based on interprofessional training courses divided into four parts theoretical training (recognition of the critically ill child / cardiorespiratory arrest, how to call for assistance), procedural simulation (ventilation / chest compression / set up an intraosseous access / call for help...), three in situ simulation scenarios of pediatric medical emergencies (with live audiovisual retransmission for observers) each ending with a debriefing and a conclusion of the day with handing over of best practice documents. The study investigation team plan to train 400 caregivers each year (including 300 nurses and nurses' aides).
The Impact-SUrVIS (Impact de la Simulation d'Urgences Vitales In Situ) study is built around the SUrVIS sessions. Through questionnaire, the study investigation team will assess the impact of this hospital program on self-confidence, the feeling of professional efficiency, interprofessional communication, and work-related stress.
Read the detailed description
The SUrVIS project is structured around a 12-persons one-day interdisciplinary in situ simulation training sessions including:
- Training in...
- Recognition of the critically ill child and pediatric cardiopulmonary arrest
- The call for help according to the SAED method (Haute Autorité de Santé)
- Interprofessional communication and human factors in healthcare
- Procedural simulation workshops: intraosseous line placement, bag-mask ventilation, emergency drugs preparation, call for help simulations...
- Three 4-persons in situ simulation scenarios of pediatric medical emergencies (e.g., cardiorespiratory arrest, acute respiratory failure, arrhythmias, cardiogenic shock, status epilepticus, pediatric polytrauma, medical emergency during a surgery...), with live audiovisual retransmission for the 8 learners not participating in the scenario. Each scenario will be followed by a 45' debriefing with all learners in a dedicated room. Scenarios will also be built around adverse events in healthcare previously analyzed in a Morbidity Mortality Review (MMR). The constitution of a small group (12 persons) allows all learners to participate at least once in the scenarios (unless one or more learners wish otherwise).
- A conclusion of the day and a hand-over of cognitive aids created by the management team.
Twelve trainees, 1/4 of whom are physicians or residents and 3/4 of whom are nurses or nursing assistants, will participate in each SUrVIS session.
All the in situ simulation scenarios will take place in the Necker - Enfants Malades Hospital departments (general pediatrics, pediatric nephrology, etc.). The main objective is to increase the psychological fidelity of these training sessions. Indeed, the learners will practice in familiar environments with the material of their daily practice. After the training day, the training team will remain at the disposal of the learners for an individual debriefing if they wish.
The Impact-SUrVIS study is built around the SUrVIS sessions. Through questionnaires, the study investigation team will assess the impact of our program. The study investigation team will send the participating nurses, nurses' aides, residents and doctors a pre-test questionnaire, based on standardized scales. Then the study investigation team will carry out a post-test re-evaluation at 3 and 6 months.
The main objective of the Impact-SUrVIS study is to evaluate the effects of the SUrVIS program on pediatric medical emergencies management self-confidence using the Hicks Self-Confidence Scale.
The secondary objectives of the Impact-SUrVIS study are to:
- Study the beneficial effects of the SUrVIS program on psychological demand, decision latitude, and social support using the Karasek survey.
- Study the impact of the SUrVIS program on the quality of life at work (work-related stress, burnout) using the Maslach Burnout Inventory.
- Being tested
- Hicks self-confidence scale, Karasek survey, Maslach Burnout Inventory
- Keywords
- Hospital healthcare simulation program, Pediatric medical emergencies, Cross-cutting skills, Communication skills, Human factors, Self-confidence, Teamwork, Team leading, Work-related stress
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hicks self-confidence scale, Karasek survey, Maslach Burnout InventoryOther
Questionnaires (Hicks self-confidence scale, Karasek questionnaire, Maslach Burnout Inventory) sent to hospital staff caregivers before and after (at 3 and 6 months) their SUrVIS training.
| Study group | Role | What they receive |
|---|---|---|
| Hospital staff caregivers | Necker - Enfants Malades hospital' nurses, nurses' aides, residents and, doctors of medicine. Receives: Other: Hicks self-confidence scale, Karasek survey, Maslach Burnout Inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeling of professional efficiency
Evaluate the effects of the SUrVIS program on pediatric medical emergencies management self-confidence using the Hicks Self-Confidence Scale.
The Hicks self-confidence scale is a Likert-type self-confidence scale (Hicks, 2006) consisting of 12 items was created to measure this variable. The response option of each item ranges from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater self-confidence.
Measured: 6 months
Secondary outcomes (2)
Psychological demand, decision latitude, and social support
Study the beneficial effects of the SUrVIS program on psychological demand, decision latitude, and social support using the Karasek questionnaire.
This questionnaire evaluates three dimensions of the psychosocial work environment: psychological demand, decision latitude, and social support. It includes 26 questions: nine for psychological demand, nine for decision latitude, and eight for social support. The proposed answers are: "Strongly disagree," "Disagree," "Agree," and "Strongly agree," which makes it possible to rate them from 1 to 4 and to calculate a score for each of the three dimensions. Then the median value of each score will be calculated, i.e., the value dividing the entire surveyed population into two equal parts: half are above this score, and the other half are below it. Job strain is defined as a situation where psychological demand is above the median and decision latitude is below the median, which constitutes a health-risk situation.
Measured: 6 months
Work-related stress and burnout
Study the impact of the SUrVIS program on the quality of life at work (work-related stress, burnout) using the Maslach Burnout Inventory (MBI)
The MBI is a 22-item frequency scale representing the three dimensions of burnout:
- Emotional exhaustion (EE)
- Depersonalization (DP) OR Dehumanization
- Loss of personal accomplishment (PA) For each dimension: " low", " moderate ", " high " score. A high score of (EE) or (DP) OR a low score of (PA) is sufficient to speak of burnout.
Depending on the number of dimensions affected, there are stages of severity. The degree of burnout is said to be:
- Low: only one dimension is affected.
- Medium: two out of three dimensions are affected.
- Severe: all three dimensions are pathological.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study startMay 2024 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Why it stopped: The manager could not start the search.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pedagogical and Psycho-social Impact of in Situ SimulationStudies 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
- Prospective
- Enrolment
- 0 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
- Matthieu BENDAVID, M.D., Principal investigator, Assistance Publique - Hôpitaux de ParisSylvain RENOLLEAU, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247580
- Sponsor's protocol ID
- APHP211546
- Acronym
- Impact-SUrVIS
- Status last verified
- Sep 2025
- First submitted
- 9 Feb 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Assessment of an Interdisciplinary and Multimodal Hospital Program of Pediatric Medical Emergencies' in Situ Simulation
- ClinicalTrials.gov ID
- NCT05247580
- Acronym / sponsor ID
- Impact-SUrVIS / APHP211546
- Keywords
- Hospital healthcare simulation program, Pediatric medical emergencies, Cross-cutting skills, Communication skills, Human factors, Self-confidence, Teamwork, Team leading
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The manager could not start the search.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2024 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 21 Feb 2022 (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.
Simulation in healthcare is becoming more and more essential in the training of paramedical and medical caregivers. It is a powerful educational tool that can enrich knowledge and skills, whether technical (setting up a venous catheter, intubation, etc...) or transversal (teamwork, communication, stress management in crises, etc.).
The hospital environment requires nurses, nurses' aides, residents, and doctors to provide human care in increasingly technical work environments while exercising increasing responsibilities. These caregivers are therefore exposed to many stressors. Several studies highlight the benefits of simulation on the ability of professionals to deal with rare and/or complex crises which they have previously faced during simulation sessions.
Beginning January 2022, the Necker - Enfants Malades hospital will start a hospital' scale training program for pediatric medical emergencies using in situ simulation of the Necker - Enfants Malades hospital.
The SUrVIS (Simulation d'Urgences Vitales In Situ) project is based on interprofessional training courses divided into four parts theoretical training (recognition of the critically ill child / cardiorespiratory arrest, how to call for assistance), procedural simulation (ventilation / chest compression / set up an intraosseous access / call for help...), three in situ simulation scenarios of pediatric medical emergencies (with live audiovisual retransmission for observers) each ending with a debriefing and a conclusion of the day with handing over of best practice documents. The study investigation team plan to train 400 caregivers each year (including 300 nurses and nurses' aides).
The Impact-SUrVIS (Impact de la Simulation d'Urgences Vitales In Situ) study is built around the SUrVIS sessions. Through questionnaire, the study investigation team will assess the impact of this hospital program on self-confidence, the feeling of professional efficiency, interprofessional communication, and work-related stress.
Detailed description
The SUrVIS project is structured around a 12-persons one-day interdisciplinary in situ simulation training sessions including:
- Training in...
- Recognition of the critically ill child and pediatric cardiopulmonary arrest
- The call for help according to the SAED method (Haute Autorité de Santé)
- Interprofessional communication and human factors in healthcare
- Procedural simulation workshops: intraosseous line placement, bag-mask ventilation, emergency drugs preparation, call for help simulations...
- Three 4-persons in situ simulation scenarios of pediatric medical emergencies (e.g., cardiorespiratory arrest, acute respiratory failure, arrhythmias, cardiogenic shock, status epilepticus, pediatric polytrauma, medical emergency during a surgery...), with live audiovisual retransmission for the 8 learners not participating in the scenario. Each scenario will be followed by a 45' debriefing with all learners in a dedicated room. Scenarios will also be built around adverse events in healthcare previously analyzed in a Morbidity Mortality Review (MMR). The constitution of a small group (12 persons) allows all learners to participate at least once in the scenarios (unless one or more learners wish otherwise).
- A conclusion of the day and a hand-over of cognitive aids created by the management team.
Twelve trainees, 1/4 of whom are physicians or residents and 3/4 of whom are nurses or nursing assistants, will participate in each SUrVIS session.
All the in situ simulation scenarios will take place in the Necker - Enfants Malades Hospital departments (general pediatrics, pediatric nephrology, etc.). The main objective is to increase the psychological fidelity of these training sessions. Indeed, the learners will practice in familiar environments with the material of their daily practice. After the training day, the training team will remain at the disposal of the learners for an individual debriefing if they wish.
The Impact-SUrVIS study is built around the SUrVIS sessions. Through questionnaires, the study investigation team will assess the impact of our program. The study investigation team will send the participating nurses, nurses' aides, residents and doctors a pre-test questionnaire, based on standardized scales. Then the study investigation team will carry out a post-test re-evaluation at 3 and 6 months.
The main objective of the Impact-SUrVIS study is to evaluate the effects of the SUrVIS program on pediatric medical emergencies management self-confidence using the Hicks Self-Confidence Scale.
The secondary objectives of the Impact-SUrVIS study are to:
- Study the beneficial effects of the SUrVIS program on psychological demand, decision latitude, and social support using the Karasek survey.
- Study the impact of the SUrVIS program on the quality of life at work (work-related stress, burnout) using the Maslach Burnout Inventory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital staff caregivers | – | Other: Hicks self-confidence scale, Karasek survey, Maslach Burnout InventoryNecker - Enfants Malades hospital' nurses, nurses' aides, residents and, doctors of medicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers staff at Necker - Enfants Malades Hospital
Key inclusion criteria (9 listed)
- Any caregivers staff at Necker - Enfants Malades Hospital agreeing to participate in the Impact-SUrVIS study and thoroughly complete the Impact-SUrVIS study questionnaires.
- Non-medical staff at Necker - Enfants Malades Hospital:
- Medical staff at Necker - Enfants Malades Hospital:
Key exclusion criteria (1 listed)
- Medical student
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 |
|---|---|---|
| Hicks self-confidence scale, Karasek survey, Maslach Burnout InventoryQuestionnaires (Hicks self-confidence scale, Karasek questionnaire, Maslach Burnout Inventory) sent to hospital staff caregivers before and after (at 3 and 6 months) their SUrVIS training. | Other | Hospital staff caregivers |
Primary outcome
Feeling of professional efficiency
Time frame: 6 months
Evaluate the effects of the SUrVIS program on pediatric medical emergencies management self-confidence using the Hicks Self-Confidence Scale. The Hicks self-confidence scale is a Likert-type self-confidence scale (Hicks, 2006) consisting of 12 items was created to measure this variable. The response option of each item ranges from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater self-confidence.
2 secondary outcomes
Psychological demand, decision latitude, and social support
Time frame: 6 months
Work-related stress and burnout
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- 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.
Matthieu BENDAVID, M.D. principal investigator
Assistance Publique - Hôpitaux de Paris
Sylvain RENOLLEAU, MD, PhD study director
Assistance Publique - 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 Pedagogical and Psycho-social Impact of in Situ Simulation, 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 9 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Sep 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Feeling of professional efficiency (time frame: 6 months). 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 25 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.