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).
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
- Conditions the study is for
- Agitation Management, Aggression, Verbal De-Escalation
- What is being tested?
- Standard Verbal De-Escalation Training and Verbal De-Escalation-Based Simulation Training
- Type of treatment
- Lifestyle or therapy programme
- 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.
Turkey (Türkiye)1 site
Public Hospital
Bursa, Bursa, 16000
Şeyma Erkuş, PhD Student, +90 537 065 9268, seymaaerkuss@gmail.com
Şeyma Erkuş, PhD Student
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.
- Conditions
- Agitation Management, Aggression, Verbal De-Escalation
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Standard Verbal De-Escalation Training; Behavioral: Verbal De-Escalation-Based Simulation Training |
| Control Group | Active comparator | Participants 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.
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.
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.
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.
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)
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.
- First posted25 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Erkuş, Uskudar University
- Investigators
- Elçin Babaoğlu Gülseven, Assoc. Prof. Dr., Study director, Uskudar University
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.