Abstract
Background Patient aggression is a persistent challenge in mental health settings, and undergraduate preparation in de-escalation remains variable. This study evaluated whether a standardized-patient (SP) de-escalation simulation improves psychological empowerment and confidence in coping with aggression among psychiatric nursing students.
Methods We conducted a parallel-group randomized controlled trial (pretest–posttest) with undergraduate psychiatric nursing students randomly assigned to either an SP-based de-escalation simulation program or routine curriculum control. The intervention comprised 12 sessions over 8 weeks (4 theory + 8 SP practical scenarios with structured debriefs aligned to INACSL standards). Primary outcomes were psychological empowerment and confidence in coping with patient aggression, assessed at baseline and immediately post-intervention using validated scales. Fidelity was supported through scripted scenarios, SP calibration, and facilitator adherence/debrief quality checks. Between-group differences in change scores were examined.
Results Compared with the control group, students in the simulation arm demonstrated significantly greater gains in both psychological empowerment and confidence in coping with aggression from pretest to posttest. Fidelity indices indicated consistent SP portrayal and facilitator adherence across sessions, and attendance was high. No adverse events were reported.
Conclusions A structured de-escalation simulation using trained standardized patients significantly improves empowerment and confidence among psychiatric nursing students. The scenario maps, learning outcomes, and debriefing approach described support replication and curriculum integration in undergraduate mental health nursing. Future work should examine longer-term retention, transfer to clinical practice, and curriculum-level outcomes.
Clinical trial number Not applicable.
Full
Article
ERCT Criteria Breakdown
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Level 1 Criteria
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C
Class-level RCT
- Randomization was at the individual student level rather than assigning whole classes (and this was not a one-to-one tutoring intervention).
- "Participants were allocated 1:1 to the experimental (de-escalation simulation) or control (routine curriculum) arm using a computer-generated random sequence..." (p. 3)
Relevant Quotes:
1) "We employed a parallel-group randomized controlled trial with pretest–posttest assessments..." (p. 3)
2) "Participants were allocated 1:1 to the experimental (de-escalation simulation) or control (routine curriculum) arm using a computer-generated random sequence..." (p. 3)
3) "The study was conducted at the Psychiatric and Mental Health Nursing Department, Faculty of Nursing, October 6 University, located in Giza Governorate, Egypt." (p. 3)
Detailed Analysis:
The ERCT C criterion requires random assignment at the class level (or stronger), unless the intervention is explicitly one-to-one tutoring/personal teaching. The paper describes a "parallel-group randomized controlled trial" where "Participants were allocated 1:1" to conditions, which indicates individual-level randomization of students rather than random assignment of intact classes.
The intervention is a group-based course component (SP simulations delivered as sessions), not a one-to-one tutoring exception.
Final summary sentence: Criterion C is not met because the study randomized individual students rather than whole classes (and no tutoring exception applies).
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E
Exam-based Assessment
- Outcomes were measured with self-report empowerment and confidence scales rather than a widely recognized standardized exam-based assessment.
- "Primary outcomes were psychological empowerment and confidence in coping with patient aggression, assessed at baseline and immediately post-intervention using validated scales." (p. 1)
Relevant Quotes:
1) "Primary outcomes were psychological empowerment and confidence in coping with patient aggression, assessed at baseline and immediately post-intervention using validated scales." (p. 1)
2) "Baseline data (pre-training) were collected... using the structured electronic self-reported questionnaire..." (p. 5)
3) "Psychological Empowerment Scale (PES)..." (p. 4)
4) "Clinical confidence in coping with patient aggression questionnaire (CCWPA)..." (p. 4)
Detailed Analysis:
The ERCT E criterion requires standardized exam-based assessments (e.g., state/national standardized tests or widely recognized standardized achievement exams). This study assesses outcomes using two questionnaire instruments (PES and CCWPA) administered as self-report measures.
While these instruments may be "validated scales," they are not standardized exam-based academic assessments of educational achievement (and the paper does not describe use of national/state exams or other standardized testing programs).
Final summary sentence: Criterion E is not met because the study uses self-report validated scales (PES and CCWPA), not standardized exam-based assessments.
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T
Term Duration
- The intervention lasted 8 weeks and outcomes were measured immediately after training, which is shorter than a full academic term (about 3–4 months) from start to measurement.
- "Immediately after the training, post-intervention data were collected from both groups..." (p. 5)
Relevant Quotes:
1) "The intervention comprised 12 sessions over 8 weeks..." (p. 1)
2) "Immediately after the training, post-intervention data were collected from both groups using the same tools." (p. 5)
3) "Data collection was carried out... during the Fall semester of the academic year 2023–2024..." (p. 5)
Detailed Analysis:
The ERCT T criterion requires that outcomes be measured at least one full academic term after the intervention begins. The paper explicitly states the intervention lasted "8 weeks" and that evaluation occurred "Immediately after the training."
Eight weeks is substantially shorter than a typical academic term (~12–16 weeks). The paper does not describe an additional later follow-up measurement at or beyond a term after the start date.
Final summary sentence: Criterion T is not met because the study measured outcomes immediately after an 8-week program, which is shorter than one academic term from start to measurement.
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D
Documented Control Group
- The control condition is clearly described (routine curriculum without simulation) and baseline characteristics and group sizes are documented.
- "Students in the control arm completed the standard psychiatric nursing course content without simulation or role-play." (p. 3)
Relevant Quotes:
1) "The control arm received the routine curriculum without simulation..." (p. 3)
2) "Students in the control arm completed the standard psychiatric nursing course content without simulation or role-play." (p. 3)
3) "The curriculum comprised 12 contact hours divided into three thematic blocks..." (p. 3)
4) "Importantly, no standardized patients, scenarios, or role-play exercises were used in the control condition." (p. 3)
5) "The results section presents data gathered from 80 psychiatric nursing students, distributed equally into experimental (n = 40) and control (n = 40) groups." (p. 6)
6) "Table 1 presents the socio-demographic characteristics of the nursing students in both the experimental and control groups." (p. 6)
Detailed Analysis:
ERCT D requires a well-documented control group including what they received and baseline/demographic information. This paper provides a detailed narrative description of the control curriculum (topics, contact hours, teaching methods, and the explicit absence of simulation/role-play) and also documents sample size by arm and baseline characteristics via Table 1.
Final summary sentence: Criterion D is met because the control condition and its instruction are described in detail and baseline group characteristics and sizes are reported.
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Level 2 Criteria
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S
School-level RCT
- The paper randomizes students within a single university department rather than randomizing at the school/site level.
- "The study was conducted at the Psychiatric and Mental Health Nursing Department, Faculty of Nursing, October 6 University..." (p. 3)
Relevant Quotes:
1) "The study was conducted at the Psychiatric and Mental Health Nursing Department, Faculty of Nursing, October 6 University, located in Giza Governorate, Egypt." (p. 3)
2) "Participants were allocated 1:1 to the experimental... or control... arm using a computer-generated random sequence..." (p. 3)
Detailed Analysis:
ERCT S requires school-level randomization among schools or equivalent institutions/sites. The paper describes one institutional setting (October 6 University) and describes allocation of participants 1:1, which indicates student-level allocation rather than school/site-level randomization.
Final summary sentence: Criterion S is not met because the study does not randomize schools/sites, only individual students in one institution.
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I
Independent Conduct
- Although randomization and assessment roles include "independent" personnel, the intervention was developed and data collection led by study authors, so the trial is not fully independent of the intervention designers.
- "GAE conceived the study, developed the simulation training, and led data collection." (p. 10)
Relevant Quotes:
1) "A computer-generated random sequence was prepared by an independent faculty member..." (p. 3)
2) "Outcome assessors and data analysts were independent of the teaching team..." (p. 3)
3) "GAE conceived the study, developed the simulation training, and led data collection." (p. 10)
Detailed Analysis:
ERCT I requires that the study be conducted independently from the authors who designed the intervention (to reduce bias in implementation and analysis).
The paper includes partial independence safeguards: an "independent faculty member" prepared the random sequence, and "Outcome assessors and data analysts" were independent of the teaching team. However, the author contributions state that an author (GAE) "developed the simulation training" and "led data collection," which indicates that key conduct of the study was not fully separated from the intervention designer(s).
Final summary sentence: Criterion I is not met because the intervention designer (an author) led data collection even though some roles (random sequence, assessors/analysts) were described as independent.
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Y
Year Duration
- Year-duration tracking is not present because outcomes were measured immediately after an 8-week intervention (and ERCT Y also cannot be met when ERCT T is not met).
- "Immediately after the training, post-intervention data were collected from both groups..." (p. 5)
Relevant Quotes:
1) "The intervention comprised 12 sessions over 8 weeks..." (p. 1)
2) "Immediately after the training, post-intervention data were collected from both groups using the same tools." (p. 5)
Detailed Analysis:
ERCT Y requires outcomes measured at least 75% of an academic year after the intervention begins. The study describes an 8-week intervention with immediate post-test measurement, which is far shorter than an academic year.
Additionally, per the ERCT instructions provided, if criterion T is not met then criterion Y is not met; here T is not met because the start-to-measurement interval is shorter than a term.
Final summary sentence: Criterion Y is not met because the study’s start-to-measurement period is only 8 weeks with an immediate post-test, far short of year-long tracking.
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B
Balanced Control Group
- The intervention’s added materials and personnel (trained standardized patients, scripted scenarios, debriefing and fidelity procedures) are integral to the treatment being tested, and the paper documents a structured routine curriculum control rather than leaving control students without educational engagement.
- "The control arm received the routine curriculum without simulation... The intervention comprised 12 sessions over 8 weeks (4 theory + 8 SP practical scenarios...)." (p. 1)
Relevant Quotes:
1) "The control arm received the routine curriculum without simulation..." (p. 3)
2) "The intervention comprised 12 sessions over 8 weeks (4 theory + 8 SP practical scenarios with structured debriefs aligned to INACSL standards)." (p. 1)
3) "Students in the control arm completed the standard psychiatric nursing course content without simulation or role-play. The curriculum comprised 12 contact hours..." (p. 3)
4) "Fidelity measures included use of scripted cue cards, props, timing windows, and SP calibration workshops." (p. 4)
Detailed Analysis:
Criterion B focuses on whether time/budget/resources are balanced across conditions unless the extra resources are explicitly integral to (and intended as) the treatment variable.
Here, the experimental condition is explicitly defined as an SP-based simulation program, which inherently requires additional resources (standardized patients, simulation setup, scripted scenarios, structured debriefing, and fidelity monitoring). These resources are not optional add- ons; they constitute the intervention being tested.
The control condition is not a "no-education" group; it is a structured routine curriculum with defined content and "12 contact hours," indicating comparable ongoing educational engagement rather than an empty baseline.
While the paper does not provide a direct minute-by-minute equivalence comparison of total contact time across arms, the key resource differences (SP simulation infrastructure) are integral to the treatment definition, not an unintended imbalance.
Final summary sentence: Criterion B is met because the resource-intensive elements are integral to the simulation intervention being tested and the control group is given a clearly specified routine curriculum rather than lacking educational inputs.
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Level 3 Criteria
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R
Reproduced
- The paper does not report an independent replication and no independent replication evidence is provided within the paper text.
Relevant Quotes:
1) "Future research should address these limitations by employing multi-site designs... and long-term evaluations..." (p. 9)
Detailed Analysis:
ERCT R requires that the study be independently replicated by a different research team in a different context and published in a peer-reviewed journal.
The paper does not present itself as a replication of a prior trial, does not cite an independent team reproducing this exact intervention and design, and only suggests that future work should include multi-site designs. No external replication studies are identified or quoted within the provided paper content.
Final summary sentence: Criterion R is not met because there is no quoted evidence of an independent peer-reviewed replication of this specific trial.
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A
All-subject Exams
- All-subject standardized exams were not used, and because ERCT E is not met, ERCT A is automatically not met.
Relevant Quotes:
1) "Primary outcomes were psychological empowerment and confidence in coping with patient aggression..." (p. 1)
2) "Three data collection instruments were utilized..." (p. 4)
Detailed Analysis:
ERCT A requires standardized exam-based assessment across all main subjects, and the provided ERCT instructions state that if criterion E is not met then A is not met.
This paper does not use standardized academic exams at all; outcomes are psychological empowerment and confidence measured via questionnaires, so E is not met and therefore A cannot be met.
Final summary sentence: Criterion A is not met because the study does not use standardized exams (and E is not met, which makes A automatically not met).
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G
Graduation Tracking
- The study did not track participants to graduation, and because ERCT Y is not met, ERCT G is automatically not met.
- "Second, the study only measured immediate post-intervention outcomes and did not include a longitudinal follow-up." (p. 9)
Relevant Quotes:
1) "Second, the study only measured immediate post-intervention outcomes and did not include a longitudinal follow-up." (p. 9)
Detailed Analysis:
ERCT G requires follow-up tracking until graduation from the relevant educational stage, and the provided ERCT instructions state that if criterion Y is not met then G is not met.
The paper explicitly acknowledges it only measured immediate post-intervention outcomes and did not include longitudinal follow-up, which is incompatible with graduation tracking. Also, Y is not met (the study is 8 weeks with immediate post-test), so G cannot be met.
Final summary sentence: Criterion G is not met because there is no longitudinal follow-up to graduation and Y is not met.
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P
Pre-Registered
- No pre-registration is provided; the paper explicitly states "Clinical trial number Not applicable."
- "Clinical trial number Not applicable." (p. 2)
Relevant Quotes:
1) "Clinical trial number Not applicable." (p. 2)
Detailed Analysis:
ERCT P requires a pre-registered protocol with a registry reference and timing before data collection begins. The paper explicitly indicates there is no trial registration number, and no registry link/ID or registration date is provided in the text.
Final summary sentence: Criterion P is not met because the study provides no pre-registration ID/date and states the clinical trial number is not applicable.
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