- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07784868
Effect of Verbal De-Escalation-Based Simulation on Agitation Management, Perception of Aggression, and Impact of Aggression in Emergency Department Nurses
21 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
78
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Şeyma Erkuş, PhD Student
- Número de teléfono: +90 537 065 92 68
- Correo electrónico: seymaaerkuss@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr.
- Número de teléfono: +90 552 541 70 69
- Correo electrónico: elcin.babaoglu@uskudar.edu.tr
Ubicaciones de estudio
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Bursa
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Bursa, Bursa, Turquía (Türkiye), 16000
- Public Hospital
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Contacto:
- Şeyma Erkuş, PhD Student
- Número de teléfono: +90 537 065 9268
- Correo electrónico: seymaaerkuss@gmail.com
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Investigador principal:
- Şeyma Erkuş, PhD Student
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Comparador activo: Control Group
Participants in this arm will receive the standard training program on verbal de-escalation-based agitation management.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Agitation Management Knowledge Test Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived Simulation Effectiveness Score
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Qualitative Themes From Semi-Structured Focus Group Interviews on Verbal De-Escalation-Based Simulation Training
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr., Uskudar University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de agosto de 2026
Publicado por primera vez (Actual)
25 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-88
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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