Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 9:08 PM
Ignite Modification Date: 2025-12-24 @ 9:08 PM
NCT ID: NCT06406504
Brief Summary: The aim of this study was to evaluate the effectiveness of in-situ simulation and moulage to improve nursing students' pressure injury classification and assessment skills. A randomized controlled model with a pretest-posttest control group was used in this study. The population of the study consists of a faculty of nursing at a state university. The sample consisted of 84 nursing students. The control group received simulation-based training using a pressure injury simulator on a standardised patient in the simulation laboratory, the in-laboratory simulation group received simulation-based training using moulage on a standardised patient in the simulation laboratory, and the in-situ simulation group received simulation-based training using moulage on a standardised patient in the clinic of a university hospital. The research data were collected by Descriptive Characteristics Form, Pressure Injury Knowledge Test, Pressure Injury Assessment Form, Performance Checklist, Students' Satisfaction and Self-Confidence Scale and Student Feedback Form.
Detailed Description: In this study, the reality of the environment was increased with the in-site simulation method, the physical reality was increased by ensuring that the standardised patient characteristics match with the patient characteristics in the real world with moulage, and the functional reality was increased by performing a wound classification and evaluation similar to the real wound with moulage. In this context, this study was conducted to determine the effect of in-situ simulation and moulage application in order to improve nursing students' skills in Pressure Injury (PI) classification and assessment. For this purpose, there are three hypotheses guiding the research: There will be a difference between the PI knowledge test scores of the groups. There will be a difference between the groups' ability to classification and assessment PI. There will be a difference between the satisfaction and self-confidence levels of the groups. This study was structured as a randomized, controlled experimental investigation with pretest and posttest control groups. It was conducted to evaluate the effectiveness of in situ simulation and moulage to improve nursing students' PI classification and evaluation skills. It was conducted at a nursing school in Turkey between September 2021 and May 2023. Simulation-based experiences were designed based on the INACSL Healthcare Simulation Standards of Best PracticeTM Simulation Design. The study design was reported following the guidelines of the Consolidated Standards of Reporting Trials (CONSORT). The study population comprised senior nursing students (N=284). The sample size was calculated on the basis of previous studies evaluating the effectiveness of the moulage method in PI assessment skills. Based on the power analysis, the study's sample size was determined to be 84 (ɑ=0.10, 1-β=0.95) with 95% power and ɑ=0.10 error (90% confidence interval). Taking into account possible losses during the study, 90 students were included. Senior nursing students who had not previously performed classification and assessment of PI, who had not attended any course related to PI, and who volunteered to participate were included in the study. In order to ensure homogeneous distribution of students in terms of academic achievement score, a statistician who was not involved in the study randomised the students according to their grade point averages at the end of the third year using a website. The simulation practices of the students in the control group (n=30) were performed with a PI simulator on a standardised patient in the simulation laboratory, the simulation practices of the students in the simulation in-laboratory group (n=30) were performed with moulage application on a standardised patient in the simulation laboratory, and the simulation practices of the students in the in-situ simulation group (n=30) were performed with moulage application on a standardised patient in a clinic of a university hospital. Since two students from each of the three groups left the study, the study was completed with 84 students.
Study: NCT06406504
Study Brief:
Protocol Section: NCT06406504