IRCT20250524065863N1 IRCT 2025-07-21 Islamic Azad University The Effect of Simulation-Based Education on Nursing Students’ Knowledge, Performance, Satisfaction and Self-Confidence in the Blood Transfusion Process and the Management of Related Complications The Effect of Simulation-Based Education on Nursing Students’ Knowledge, Performance, Satisfaction and Self-Confidence in the Blood Transfusion Process and the Management of Related Complications 2025-07-31 anticipated 60 Complete https://irct.ir/trial/84853 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: This study is a two-group parallel educational trial with a 1:1 allocation ratio. Sixty nursing students in semesters 4-6 who meet the inclusion criteria will be enrolled in the study after providing informed consent and will be assigned to two groups: ;intervention; (theoretical training + simulation-based training) and ;control; (theoretical training only with similar content). The unit of randomization is the ;individual.; Allocation concealment is performed using sequentially numbered; opaque; sealed; and consecutively numbered envelopes within each stratum. After generating the list; an independent statistician prints a group code sheet (A = intervention; B = control) for each sequence number; places it in an envelope; seals the seam; signs the seal; and keeps the envelopes in a locked box. After registering and coding each student and completing the consent form; the recruitment officer (who does not have access to the master list) opens the next envelope from the same stratum in the presence of a witness and records the group code on the ;Allocation Registration Form; (envelope number; date; officer's signature; witness's signature). In this way; the group is not predictable until the moment the envelope is opened, Blinding description: Complete blinding of participants and instructors is not feasible due to the nature of the educational intervention (presence or absence of simulation). Therefore; the design is a single-blind type: the outcome assessor (evaluating OSCE test scores and awareness scores) and the statistical analyst are blinded to group allocation. To implement blinding; only anonymous student codes are recorded on all questionnaires and OSCE sheets; and students commit in writing before the test not to disclose their training modality to the assessor; following written instructions. Data entry is performed by an individual who does not have access to the group decoding table. The data are provided to the analyst in groups labeled "Group B" and "Group A;" and after initial analysis and database locking; the decoding is carried out. To prevent "between-group contamination;" simulation sessions are held at separate times; and students in the intervention group sign a written commitment not to share any scenario details with others until after the post-test. The theoretical content (slides; instructor; duration) remains identical in both groups; so the only variable difference is "adding simulation." Practical performance assessments are conducted using a standard OSCE station (15 minutes) and a validated checklist (21 items; including 4 critical items) both before and after the intervention in each group. The evaluator does not participate in the educational intervention and is unaware of participant group allocation. To monitor the stability of the assessment; a second blinded evaluator randomly attends 20% of the assessments, and the agreement coefficient (Kappa) is calculated; if κ < 0.75; re-training is conducted. In case of unintentional group disclosure (e.g.; a student verbally revealing their training method); the incident is recorded in the "Blinding Breach Incident Form;" and sensitivity analysis is performed excluding that case. The randomization list is securely stored in encrypted form with an independent statistician and is only released after database locking. All procedures (sequence generation; envelope preparation; opening; recording; and storage) are documented within an standard operating procedure; which can be provided upon request to the ethics committee. N/A Clinical simulation, blood transfusion. Intervention :Intervention: Simulation-based training for the intervention group will be held after a 4-hour lecture session. Implementation of simulation scenarios: Given the number of students in the intervention group (30), the scenario will be held over three days, one in the morning and one in the evening. To perform the intervention, low-realism simulation equipment is used, which includes a clinical skills center station for the first encounter (care before, during, and after blood transfusion) and a second station (for dealing with blood transfusion complications).. Yes - There is a plan to make this available What will be shared: Only the research team has permission to access the data. When: up to five years To whom: It can only be used for study and for the needs of big data studies for others. Conditions: Based on the journal's request, the reviewer and the researcher will be sent the big data. Where to obtain: Tehran; Ashrafi Esfahani; Bagh-e Feyz; 22 Bahman Street; Amir Ebrahim Street; between Baharan and Chaman; Bahareh Building; Unit 5559; Zohre JafareePoor. How to obtain: Based on the journal's request, the reviewer and the researcher will be sent the big data. Comments: