- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07784868
Effect of Verbal De-Escalation-Based Simulation on Agitation Management, Perception of Aggression, and Impact of Aggression in Emergency Department Nurses
21 août 2026 mis à jour par: Şeyma Erkuş, Uskudar University
This mixed-methods randomized controlled study aims to evaluate the effects of verbal de-escalation-based simulation training on emergency department nurses' knowledge of agitation management, perceptions of aggression, and the extent to which they are affected by aggressive and violent behaviors.
A total of 78 emergency department nurses will be randomly assigned to an intervention group (n=39) or a control group (n=39).
Both groups will receive the same standard training program on verbal de-escalation-based agitation management.
After the standard training, the intervention group will participate in standardized patient simulation and debriefing sessions.
Outcomes will be assessed before the intervention, after the intervention, and at a three-month follow-up.
In addition, focus group interviews will be conducted with participants in the intervention group at the three-month follow-up to explore their experiences with the simulation-based training.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
78
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Şeyma Erkuş, PhD Student
- Numéro de téléphone: +90 537 065 92 68
- E-mail: seymaaerkuss@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr.
- Numéro de téléphone: +90 552 541 70 69
- E-mail: elcin.babaoglu@uskudar.edu.tr
Lieux d'étude
-
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Bursa
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Bursa, Bursa, Turquie (Türkiye), 16000
- Public Hospital
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Contact:
- Şeyma Erkuş, PhD Student
- Numéro de téléphone: +90 537 065 9268
- E-mail: seymaaerkuss@gmail.com
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Chercheur principal:
- Şeyma Erkuş, PhD Student
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Working as a nurse in the adult emergency department of the hospital where the study will be conducted
- Working full-time as a nurse
- Willing to participate in the study
Exclusion Criteria:
- Being on leave or otherwise unable to work during the study period
- Having previously received simulation-based training on verbal de-escalation
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention Group
Participants in this arm will receive the standard training program on verbal de-escalation-based agitation management, followed by standardized patient simulation and debriefing sessions.
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Participants will receive a five-session standard training program on verbal de-escalation-based agitation management.
The program covers recognition of agitation and aggression, perceptions and interpretation of aggression, assessment and safe management of the agitated patient, verbal de-escalation principles and techniques, and approaches to protect and strengthen nurses' well-being.
Following the standard training, participants in the intervention group will take part in a standardized patient simulation involving an agitated patient.
The simulation includes prebriefing, scenario-based practice, and structured debriefing based on the PEARLS framework.
A structured observation form will be used to provide feedback during debriefing and will not be used as an outcome measure.
|
|
Comparateur actif: Control Group
Participants in this arm will receive the standard training program on verbal de-escalation-based agitation management.
|
Participants will receive a five-session standard training program on verbal de-escalation-based agitation management.
The program covers recognition of agitation and aggression, perceptions and interpretation of aggression, assessment and safe management of the agitated patient, verbal de-escalation principles and techniques, and approaches to protect and strengthen nurses' well-being.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Agitation Management Knowledge Test Score
Délai: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Agitation management knowledge will be assessed using the researcher-developed Agitation Management Knowledge Test.
The test consists of 25 items with three response options: True, False, and Don't Know.
Total scores range from 0 to 100, with higher scores indicating greater knowledge of agitation management and verbal de-escalation.
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Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Change in Functional Perception of Aggression Score
Délai: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Functional perception of aggression will be assessed using the functional subscale of the Perception of Aggression Scale (POAS).
The POAS consists of 29 items rated on a 5-point Likert scale.
The functional subscale consists of 12 items.
The mean subscale score is calculated by dividing the sum of the item scores by the number of items in the subscale and ranges from 1 to 5. Higher scores indicate a greater tendency to perceive aggression as functional, acceptable, and a healthy response.
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Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Change in Dysfunctional Perception of Aggression Score
Délai: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Dysfunctional perception of aggression will be assessed using the dysfunctional subscale of the Perception of Aggression Scale (POAS).
The POAS consists of 29 items rated on a 5-point Likert scale.
The dysfunctional subscale consists of 17 items.
The mean subscale score is calculated by dividing the sum of the item scores by the number of items in the subscale and ranges from 1 to 5. Higher scores indicate a greater tendency to perceive aggression as dysfunctional, unacceptable, and undesirable.
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Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Change in Impact of Patient Aggression Score
Délai: Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Impact of patient aggression will be assessed using the Impact of Patient Aggression on Carers Scale (IMPACS).
The scale consists of 7 items and two subscales: Corruption of Relation Between Care Provider and Patient and Not Feeling Confident.
Total scores range from 7 to 35, with higher scores indicating a greater negative impact of patient aggression.
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Baseline; immediately after completion of the simulation and debriefing sessions in the intervention group (with the control group assessed at the corresponding time point); and 3 months after completion of the intervention period.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perceived Simulation Effectiveness Score
Délai: Immediately after completion of the debriefing session following the simulation.
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Perceived simulation effectiveness will be assessed using the Modified Simulation Effectiveness Tool (SET-M) in the intervention group.
The scale consists of 19 items and four subscales: prebriefing, learning, confidence, and debriefing.
Total scores range from 19 to 95, with higher scores indicating a more positive perception of the effectiveness of the simulation-based learning experience.
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Immediately after completion of the debriefing session following the simulation.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Qualitative Themes From Semi-Structured Focus Group Interviews on Verbal De-Escalation-Based Simulation Training
Délai: 3 months after the intervention.
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Participants' experiences with the verbal de-escalation-based simulation training will be examined through focus group interviews using researcher-developed semi-structured interview questions.
Interview transcripts will be analyzed using content analysis, and the findings will be reported as qualitative themes.
The interviews will address perceived changes in knowledge and skills, transfer of knowledge and skills to clinical practice, perceptions of and emotional responses to agitated patients, and maintenance of training effects in clinical practice.
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3 months after the intervention.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr., Uskudar University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
1 février 2027
Achèvement de l'étude (Estimé)
1 février 2027
Dates d'inscription aux études
Première soumission
17 août 2026
Première soumission répondant aux critères de contrôle qualité
21 août 2026
Première publication (Réel)
25 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-88
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .