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Agitation ManagementNCT07784868

Effect of Verbal De-Escalation-Based Simulation on Agitation Management, Perception of Aggression, and Impact of Aggression in Emergency Department Nurses

A study testing Standard Verbal De-Escalation Training and Verbal De-Escalation-Based Simulation Training in people with Agitation Management and Aggression, run by Uskudar University at 1 site in Turkey (Türkiye).

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Standard Verbal De-Escalation Training and Verbal De-Escalation-Based Simulation Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2026to Feb 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Being on leave or otherwise unable to work during the study period
  • Having previously received simulation-based training on verbal de-escalation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Şeyma Erkuş, PhD Student contact

+90 537 065 92 68

seymaaerkuss@gmail.com

Elçin Babaoğlu Gülseven, Assoc. Prof. Dr. contact

+90 552 541 70 69

elcin.babaoglu@uskudar.edu.tr

Turkey (Türkiye)1 site
  • Public Hospital

    Bursa, Bursa, 16000

    Şeyma Erkuş, PhD Student, +90 537 065 9268, seymaaerkuss@gmail.com

    Şeyma Erkuş, PhD Student

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
Standard Verbal De-Escalation Training, Verbal De-Escalation-Based Simulation Training
Keywords
Verbal De-Escalation, Agitation Management, Aggression, Simulation Training, Patient Simulation, Nurses, Emergency Nursing, Aggression Perception, Impact of Aggression
Medical subject headings
Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Verbal De-Escalation TrainingBehavioural

    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.

  • Verbal De-Escalation-Based Simulation TrainingBehavioural

    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.

Study groups in NCT07784868
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants in this arm will receive the standard training program on verbal de-escalation-based agitation management, followed by standardized patient simulation and debriefing sessions.
Receives: Behavioral: Standard Verbal De-Escalation Training; Behavioral: Verbal De-Escalation-Based Simulation Training
Control GroupActive comparatorParticipants in this arm will receive the standard training program on verbal de-escalation-based agitation management.
Receives: Behavioral: Standard Verbal De-Escalation Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Agitation Management Knowledge Test Score

    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.

    Measured: 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.

  2. Change in Functional Perception of Aggression Score

    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.

    Measured: 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.

  3. Change in Dysfunctional Perception of Aggression Score

    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.

    Measured: 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.

  4. Change in Impact of Patient Aggression Score

    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.

    Measured: 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.

Secondary outcomes (1)
  1. Perceived Simulation Effectiveness Score

    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.

    Measured: Immediately after completion of the debriefing session following the simulation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07784868
Sponsor's protocol ID
2026-88
Status last verified
Aug 2026
First submitted
17 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to participant privacy and confidentiality considerations.

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