- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
78
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Şeyma Erkuş, PhD Student
- Número de telefone: +90 537 065 92 68
- E-mail: seymaaerkuss@gmail.com
Estude backup de contato
- Nome: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr.
- Número de telefone: +90 552 541 70 69
- E-mail: elcin.babaoglu@uskudar.edu.tr
Locais de estudo
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Bursa
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Bursa, Bursa, Turquia (Türkiye), 16000
- Public Hospital
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Contato:
- Şeyma Erkuş, PhD Student
- Número de telefone: +90 537 065 9268
- E-mail: seymaaerkuss@gmail.com
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Investigador principal:
- Şeyma Erkuş, PhD Student
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Agitation Management Knowledge Test Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Perceived Simulation Effectiveness Score
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Qualitative Themes From Semi-Structured Focus Group Interviews on Verbal De-Escalation-Based Simulation Training
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr., Uskudar University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
1 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
17 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de agosto de 2026
Primeira postagem (Real)
25 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-88
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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