Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06406504 |
Other study ID # |
MehmetAkifU-SBF-HEÖ-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
June 22, 2023 |
Study information
Verified date |
May 2024 |
Source |
Mehmet Akif Ersoy University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.