Public Hospital
Bursa, 16000, Turkey (Türkiye)
Location contact
Şeyma Erkuş, PhD Student
CONTACT
Şeyma Erkuş, PhD Student
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07784868
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.
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Interventional
Not applicable
Bursa, 16000, Turkey (Türkiye)
Şeyma Erkuş, PhD Student
CONTACT
Şeyma Erkuş, PhD Student
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: Immediately after completion of the debriefing session following the simulation.
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.
Time frame: 3 months after the intervention.
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.
Contact information is provided by the study sponsor or research team.
Elçin Babaoğlu Gülseven, Assoc. Prof. Dr.
CONTACT
Şeyma Erkuş, PhD Student
CONTACT
Uskudar University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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