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WithdrawnNCT05247580Impact-SUrVISUpdated Sep 25, 2025

Impact of Pediatric Medical Emergencies' in Situ Simulations

An observational study in Pedagogical and Psycho-social Impact of in Situ Simulation, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Why this study was withdrawn
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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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 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.

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.
02

Conditions studied

  • Pedagogical and Psycho-social Impact of in Situ Simulation

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Keywords

  • Hospital healthcare simulation program
  • Pediatric medical emergencies
  • Cross-cutting skills
  • Communication skills
  • Human factors
  • Self-confidence
  • Teamwork
  • Team leading
  • Work-related stress
03

In context

Occupational Stress

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

Browse Occupational Stress studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Caregivers staff at Necker - Enfants Malades Hospital

Inclusion criteria

  1. Any caregivers staff at Necker - Enfants Malades Hospital agreeing to participate in the Impact-SUrVIS study and thoroughly complete the Impact-SUrVIS study questionnaires.
  2. Non-medical staff at Necker - Enfants Malades Hospital:

    • Attending nurses
    • Attending nurses' aides
    • Student nurse
    • Student nurses' aides
  3. Medical staff at Necker - Enfants Malades Hospital:

    • Doctor of Medicine (M.D.)
    • Pediatrics, Emergency Medicine and Anesthesia/Intensive care Residents.

Exclusion criteria

Exclusion Criteria:

Medical student

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Hospital staff caregivers

    Necker - Enfants Malades hospital' nurses, nurses' aides, residents and, doctors of medicine.

    Other: Hicks self-confidence scale, Karasek survey, Maslach Burnout Inventory

Interventions

  • OtherHicks self-confidence scale, Karasek survey, Maslach Burnout Inventory

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Hôpital Necker-Enfants Malades
    Paris, 75015, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05247580
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Feb 21, 2022
Start date
May 2024 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Sep 25, 2025

Study contacts

Matthieu BENDAVID, M.D.
principal investigator · Assistance Publique - Hôpitaux de Paris
Sylvain RENOLLEAU, MD, PhD
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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