Abstract
BACKGROUND: Ensuring accurate assessment of patients' health is paramount in nursing interventions. The Glasgow Coma Scale (GCS) plays a crucial role in evaluating patients' conditions and is deemed a fundamental clinical skill for nursing teams. However, errors in GCS assessment can significantly impact patient care, particularly as nursing students often lack sufficient training in assessing consciousness levels. OBJECTIVE: This study aimed to compare the effectiveness of standardized patient-based training and video-based training (VBT) on nursing students' ability to assess the level of consciousness. METHOD AND MATERIALS: This randomized controlled trial study included nursing students from the fourth semester in 2023. Seventy students were selected through convenience sampling and randomly allocated to two groups (n = 35 per group). Group 1 received VBT, while Group 2 received training with standardized patients. The skill of assessing consciousness levels was evaluated using the Objective Structured Clinical Examination method. Data analysis was performed using SPSS V22 statistical software. RESULTS: The mean score of the verbal response assessment in the standardized patient-assisted education group was 3.42 +/- 0.84 and that in the video-based training (VBT) group was 2.85 +/- 1.09, which was statistically significant (P = 0.025). Additionally, the total test score was significantly higher in the standardized patient-assisted training group (13.21 +/- 1.49) compared to the VBT group (12.15 +/- 2.22) (P = 0.032). CONCLUSION: Training with standardized patients significantly improves nursing students' ability to assess consciousness levels compared to VBT.
Full
Article
ERCT Criteria Breakdown
-
Level 1 Criteria
-
C
Class-level RCT
- Randomisation was performed at the individual student level rather than by whole classes or schools, so the class-level requirement fails.
- "Utilizing the RANDBETWEEN function in Microsoft Excel (version 14.00 for Windows), participants were randomly allocated into two distinct groups."
Relevant Quotes:
1) "Following the acquisition of written and informed consent from eligible participants, a comprehensive list was compiled. Utilizing the RANDBETWEEN function in Microsoft Excel (version 14.00 for Windows), participants were randomly allocated into two distinct groups." (p. 3)
2) "Seventy students were selected through convenience sampling and randomly allocated to two groups (n = 35 per group). Group 1 received VBT, while Group 2 received training with standardized patients." (p. 1, Abstract)
3) "All fourth-term nursing students of the Nursing and Midwifery School in Yazd, Iran, formed the statistical population of the study." (pp. 2-3)
4) "Participants were divided into three groups, each consisting of 11-12 students, to maintain an optimal instructor-to-student ratio." (p. 3)
Detailed Analysis:
The ERCT C criterion requires randomisation at the class level or stronger (school level), to prevent contamination between treatment and control students. Here, randomisation was performed at the individual student level using the RANDBETWEEN function in Excel, drawing from a single pool of fourth-term nursing students in one school. The subsequent "three groups of 11-12 students" were only logistical sub-groupings for training delivery within each arm, not the unit of randomisation.
The exception for one-to-one or personal tutoring does not apply, because the intervention was delivered to groups of students, not as individual tutoring. Because individual students within the same cohort were randomised (creating clear contamination risk between the two arms), the class-level requirement is not satisfied.
Criterion C is not met because randomisation was conducted at the individual student level within a single cohort, not at the class or school level.
-
E
Exam-based Assessment
- The study used a custom OSCE checklist developed by the research team, not a recognised standardised exam, so the criterion fails.
- "To develop the checklist, the research team first drafted the content of the scenarios and questions ... the final questionnaire, consisting of three questions and four scenarios, was prepared."
Relevant Quotes:
1) "The instrument of this study included a checklist of demographic information for nurses (age, sex, marital status) and a checklist of consciousness level assessment skills based on the GCS criterion." (p. 4)
2) "To develop the checklist, the research team first drafted the content of the scenarios and questions. Relevant materials were gathered from reference books and related articles. The draft was then sent via email to ten experts ... After reviewing their feedback and making the necessary revisions, the final questionnaire, consisting of three questions and four scenarios, was prepared." (p. 4)
3) "Skill assessment was conducted using the OSCE exam method." (p. 4)
4) "To assess the reliability of the scoring for the four checklist stations, 20 seventh-semester nursing students participated in an OSCE ... The inter-rater reliability was calculated to be 0.96." (p. 4)
Detailed Analysis:
The ERCT E criterion requires a standardised, widely recognised exam that was not created specifically for the study. In this paper, the outcome was measured with an Objective Structured Clinical Examination (OSCE) whose checklist and scenarios were drafted by the research team from reference books and articles, then reviewed by experts. Although OSCE is a recognised assessment format and inter-rater reliability was established (0.96), the specific instrument is a custom, researcher-developed checklist created for this study, not a standard state-wide or national standardised exam.
Criterion E is not met because outcomes were measured with a custom-made OSCE checklist developed by the researchers rather than a recognised standardised exam.
-
T
Term Duration
- The intervention was a single short session with outcomes assessed immediately afterward, well under one academic term.
- "For all participants, theoretical basics were provided using PowerPoint, which lasted 20 min. Then, in Group 1, VBT was provided, and in Group 2, training with a standardized patient-based was separately conducted for each group."
Relevant Quotes:
1) "This randomized controlled trial study was conducted in Nursing and Midwifery School in Yazd, Iran, from September to December 2023." (p. 2)
2) "For all participants, theoretical basics were provided using PowerPoint, which lasted 20 min. Then, in Group 1, VBT was provided, and in Group 2, training with a standardized patient-based was separately conducted for each group." (p. 3)
3) "Each case assessment and discussion was allocated five min, allowing for a total of 20 min across the four stations. The session concluded with a 10-min wrap-up." (p. 4)
4) "Skill assessment was conducted using the OSCE exam method." (p. 4)
Detailed Analysis:
The ERCT T criterion requires that outcomes be measured at least one full academic term (about 3-4 months) after the intervention begins. In this study, the intervention was a single, short training session (a 20-minute PowerPoint plus a video session or approximately 30 minutes of standardized-patient stations), and the OSCE skill assessment was administered immediately following training. Although the overall research window spans September to December 2023, this reflects recruitment, standardized-patient preparation, and delivery logistics, not a term-long interval between intervention start and outcome measurement. There is no follow-up assessment one term later.
Criterion T is not met because outcomes were measured immediately after a single short training session, far short of a full academic term.
-
D
Documented Control Group
- Both groups' demographics, sizes, and received conditions are documented in Table 3 and the CONSORT diagram, satisfying documentation.
- "Table 3 demonstrates that there was no significant difference between the groups in terms of demographic characteristics (P >= 0.05)."
Relevant Quotes:
1) "A total of 70 eligible nursing students participated in the study (n = 35/each group). Two participants from VBT group and three from SPT group dropped out, resulting in the analysis of data from 65 participants." (p. 5)
2) "Table 3 demonstrates that there was no significant difference between the groups in terms of demographic characteristics (P >= 0.05)." (p. 5)
3) "Table 3: Demographic characteristics ... Age 22.15+/-0.834 (VBT) / 22.19+/-0.931 (SPT); Average 15.71+/-1.21 / 16.08+/-1.32; Sex Women 18 (54.5) / 16 (50); Marital status Single 26 (78.8) / 26 (81.2)." (p. 6, Table 3)
4) "in Group 1, VBT was provided, and in Group 2, training with a standardized patient-based was separately conducted." (p. 3)
Detailed Analysis:
This is a head-to-head comparison of two active training methods, where each arm serves as the comparator (control) for the other. The ERCT D criterion requires that the comparison/control group be well documented with demographics, baseline characteristics, size, and conditions. Table 3 provides the size (n = 33 and n = 32 after dropout), age, sex, marital status, and academic average for both groups, and the CONSORT flow diagram (Figure 1) documents enrollment, allocation, and attrition. The condition each group received is clearly described.
Criterion D is met because the comparator group's demographics, size, and received condition are clearly documented in Table 3 and the CONSORT diagram.
-
Level 2 Criteria
-
S
School-level RCT
- The trial randomised individual students within one school, so school-level randomisation is not met.
- "All fourth-term nursing students of the Nursing and Midwifery School in Yazd, Iran, formed the statistical population of the study."
Relevant Quotes:
1) "This randomized controlled trial study was conducted in Nursing and Midwifery School in Yazd, Iran." (p. 2)
2) "Utilizing the RANDBETWEEN function in Microsoft Excel (version 14.00 for Windows), participants were randomly allocated into two distinct groups." (p. 3)
3) "All fourth-term nursing students of the Nursing and Midwifery School in Yazd, Iran, formed the statistical population of the study." (pp. 2-3)
Detailed Analysis:
The ERCT S criterion requires randomisation at the school or institutional/unit level. This study was conducted within a single school (the Nursing and Midwifery School in Yazd), and randomisation was performed at the individual student level. No schools, centers, or sites were randomised.
Criterion S is not met because randomisation was at the individual student level within a single school, not at the school level.
-
I
Independent Conduct
- The same authors designed, delivered, and evaluated the interventions with no independent evaluator, so independence fails.
- "MJ and FS designed the study and conducted the research. Monitoring, evaluating and analyzing the data was done by all authors."
Relevant Quotes:
1) "MJ and FS designed the study and conducted the research. Monitoring, evaluating and analyzing the data was done by all authors." (p. 8)
2) "This article is derived from the master's thesis of M.Sc. Faezeh Soltanian with code 15203 at Shahid Sadoughi University of Medical Sciences." (p. 8)
3) "To create the educational video, the research team conducted a comprehensive review of the GCS assessment process and designed a detailed implementation scenario." (p. 3)
4) "The examiner recorded each student's scores on a checklist ... Each station was evaluated by two trained examiners." (pp. 4-5)
Detailed Analysis:
The ERCT I criterion requires that the study be conducted independently from those who designed the intervention, to reduce bias. Here the same research team designed both interventions (produced the educational video and selected/trained the standardized patients), developed the assessment checklist, delivered the training, and analyzed the data. The paper states the authors designed and conducted the research, and it is derived from a co-author's master's thesis. No external or third-party evaluator conducted the trial or analysis. The paper further notes that blinding was not feasible.
Criterion I is not met because the same team designed the interventions, delivered them, and evaluated outcomes, with no independent third-party conduct.
-
Y
Year Duration
- The intervention lasted a single session with immediate assessment, nowhere near a year, and T is not met.
- "Each case assessment and discussion was allocated five min, allowing for a total of 20 min across the four stations. The session concluded with a 10-min wrap-up."
Relevant Quotes:
1) "For all participants, theoretical basics were provided using PowerPoint, which lasted 20 min." (p. 3)
2) "Each case assessment and discussion was allocated five min, allowing for a total of 20 min across the four stations. The session concluded with a 10-min wrap-up." (p. 4)
3) "This randomized controlled trial study was conducted in Nursing and Midwifery School in Yazd, Iran, from September to December 2023." (p. 2)
Detailed Analysis:
The ERCT Y criterion requires outcomes to be measured at least 75% of a full academic year after the intervention begins. Per the standard, if the weaker Term Duration (T) criterion is not met, then Y cannot be met. Here T is not met: the intervention was a single short session with immediate outcome assessment. There was no year-long tracking of participants.
Criterion Y is not met because outcomes were measured immediately after a single session, and criterion T (its weaker prerequisite) is also not met.
-
B
Balanced Control Group
- Both arms received the same theoretical session and comparable short training time, with only the instructional modality differing, so resources are balanced.
- "For all participants, theoretical basics were provided using PowerPoint, which lasted 20 min. Then, in Group 1, VBT was provided, and in Group 2, training with a standardized patient-based was separately conducted for each group."
Relevant Quotes:
1) "For all participants, theoretical basics were provided using PowerPoint, which lasted 20 min. Then, in Group 1, VBT was provided, and in Group 2, training with a standardized patient-based was separately conducted for each group." (p. 3)
2) "Participants were divided into three groups, each consisting of 11-12 students ... The finalized video demonstrating GCS assessment was presented to each group ... Afterward, the practice scenarios were shown, and students were instructed to record their GCS assessments on note cards." (p. 3)
3) "For hands-on practice, four stations were prepared, each featuring one standardized patient ... Each case assessment and discussion was allocated five min, allowing for a total of 20 min across the four stations. The session concluded with a 10-min wrap-up." (p. 4)
4) "Second, the VBT content faced challenges related to lower engagement and reduced appeal ... nursing instructors and standardized patient trainers were involved in the video production process to improve its quality and relevance." (p. 7)
Detailed Analysis:
Criterion B compares the time, budget, and materials provided to each condition. This is a two-arm active comparison of two teaching modalities rather than an intervention-versus-nothing design. Both arms received the identical 20-minute PowerPoint theoretical basics, then a comparable short instructional session on the same GCS content: the VBT arm watched the demonstration video plus practice scenarios with group discussion, while the SPT arm completed four standardized-patient stations (approximately 20 minutes) plus a 10-minute wrap-up. The overall instructional time and content coverage were broadly matched, and the differences (video versus live standardized patients) are integral to the instructional method being contrasted rather than a separable add-on of extra time or budget given only to one group. This mirrors an active-control design with comparable dosage.
Criterion B is met because both conditions received comparable educational time and content, with the remaining difference being the instructional modality that is the object of the comparison.
-
Level 3 Criteria
-
R
Reproduced
- The authors state this is the first comparison of these methods and an internet search found no independent replication.
- "based on our present knowledge, no specific investigation has been conducted to compare these two methods at all."
Relevant Quotes:
1) "based on our present knowledge, no specific investigation has been conducted to compare these two methods at all." (p. 7)
2) "Given the importance of the abovementioned issues and the lack of research comparing the effectiveness of standardized patient-based training (SPT) and video-based training (VBT) in teaching nursing students to assess consciousness levels, this study was conducted to address this gap." (p. 2)
Detailed Analysis:
The ERCT R criterion requires independent replication of this specific study by a different research team in a different context, published in a peer-reviewed journal. The authors explicitly state that no prior investigation has compared these two methods, framing their study as filling a gap. An internet search (Google Scholar, PubMed/PMC, and general web) for any independent replication of this specific SPT versus VBT consciousness-assessment trial returned no such study; the paper is itself very recent (published 2026). Related studies located (e.g., video GCS training for surgical residents by Bajaj et al. 2020, and standardized-patient studies in other clinical topics) are not replications of this particular study or design.
Criterion R is not met because no independent replication of this specific trial exists; the authors present it as the first such comparison and no reproducing study was found on internet search.
-
A
All-subject Exams
- Only a single skill domain was measured and criterion E is not met, so the all-subject requirement fails.
- "The skill of assessing consciousness levels was evaluated using the Objective Structured Clinical Examination method."
Relevant Quotes:
1) "The skill of assessing consciousness levels was evaluated using the Objective Structured Clinical Examination method." (p. 1, Abstract)
2) "Each scenario consisted of three components: eye response, motor response, and verbal response ... For the fifth station, which included three specific questions ... the total score for each individual ranged from 0 to 15." (p. 4)
3) "Table 4: Comparison of the score of the skill of measuring the level of consciousness in two study groups: Visual response, Motor response, Verbal response, Knowledge, Total score." (p. 6)
Detailed Analysis:
The ERCT A criterion requires measurement across all main subjects using standardised exam-based assessments, and it explicitly depends on criterion E being met. Criterion E is not met (the assessment was a custom OSCE checklist, not a standardised exam), so A automatically fails. Moreover, the study measured only a single narrow skill domain (GCS/consciousness assessment), with no assessment of other core subjects.
Criterion A is not met because criterion E is not met and only a single specialised skill domain was assessed.
-
G
Graduation Tracking
- The study measured a single immediate outcome with no graduation tracking or follow-up publication, and criterion Y is not met.
Relevant Quotes:
1) "Skill assessment was conducted using the OSCE exam method." (p. 4)
2) "This randomized controlled trial study was conducted in Nursing and Midwifery School in Yazd, Iran, from September to December 2023." (p. 2)
3) "This study has several limitations." (p. 7)
Detailed Analysis:
The ERCT G criterion requires tracking participants through graduation and depends on criterion Y being met. Criterion Y is not met, so G automatically fails. The study assessed the outcome once, immediately after training, with no long-term follow-up and no tracking of students toward graduation. An internet search for subsequent follow-up or graduation-tracking publications by the same author team (Garizi, Soltanian, Javadi et al.) on this cohort found no such paper.
Criterion G is not met because there was no follow-up to graduation, no follow-up publication was found on internet search, and criterion Y (its prerequisite) is not met.
-
P
Pre-Registered
- The trial was registered in the IRCT in August 2023, before the September-December 2023 data collection, satisfying pre-registration.
- "it was registered in the Iranian Registry of Clinical Trials system with the code IRCT2023081405914, and the update date was 23/8/2023."
Relevant Quotes:
1) "This study was approved on 5/10/2023 by the Ethics Committee of Yazd University of Medical Sciences (ethics code: IR.SSU.REC.1402.010). Subsequently, it was registered in the Iranian Registry of Clinical Trials system with the code IRCT2023081405914, and the update date was 23/8/2023." (p. 5)
2) "This randomized controlled trial study was conducted in Nursing and Midwifery School in Yazd, Iran, from September to December 2023." (p. 2)
Detailed Analysis:
The ERCT P criterion requires that the study protocol be registered before data collection began. The paper reports registration in the Iranian Registry of Clinical Trials (IRCT) with code IRCT2023081405914. The IRCT registration code embeds the initial registration date in its digits (2023-08-14), and the stated update date is 23/8/2023; both precede the data-collection window of September to December 2023. The IRCT registry page for this exact code could not be directly retrieved during internet verification, but the code's embedded date and the reported update date are internally consistent and both fall before data collection. Registration in a recognised trial registry before data collection is the transparency safeguard this criterion targets.
Criterion P is met because the trial was registered in the Iranian Registry of Clinical Trials (August 2023) before data collection began in September 2023.
Request an Update or Contact Us
Are you the author of this study? Let us know if you have any questions or updates.