- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07784868
Effect of Verbal De-Escalation-Based Simulation on Agitation Management, Perception of Aggression, and Impact of Aggression in Emergency Department Nurses
21 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
78
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Şeyma Erkuş, PhD Student
- Telefonnummer: +90 537 065 92 68
- E-post: seymaaerkuss@gmail.com
Studera Kontakt Backup
- Namn: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr.
- Telefonnummer: +90 552 541 70 69
- E-post: elcin.babaoglu@uskudar.edu.tr
Studieorter
-
-
Bursa
-
Bursa, Bursa, Turkiet (Türkiye), 16000
- Public Hospital
-
Kontakt:
- Şeyma Erkuş, PhD Student
- Telefonnummer: +90 537 065 9268
- E-post: seymaaerkuss@gmail.com
-
Huvudutredare:
- Şeyma Erkuş, PhD Student
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Aktiv komparator: Control Group
Participants in this arm will receive the standard training program on verbal de-escalation-based agitation management.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Agitation Management Knowledge Test Score
Tidsram: 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.
|
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
Tidsram: 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.
|
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
Tidsram: 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.
|
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
Tidsram: 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.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perceived Simulation Effectiveness Score
Tidsram: 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.
|
Immediately after completion of the debriefing session following the simulation.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Qualitative Themes From Semi-Structured Focus Group Interviews on Verbal De-Escalation-Based Simulation Training
Tidsram: 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.
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3 months after the intervention.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Elçin Babaoğlu Gülseven, Assoc. Prof. Dr., Uskudar University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 februari 2027
Avslutad studie (Beräknad)
1 februari 2027
Studieregistreringsdatum
Först inskickad
17 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
21 augusti 2026
Första postat (Faktisk)
25 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-88
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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