- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06566924
The Effect of Standardised Patient Simulation in Nursing Education
The Effect of Standardised Patient Simulation on Nursing Students' Knowledge, Skills and Satisfaction in Isolated Patient Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Material and method of the research:
Type of Study: The study was designed as randomized controlled experimental type.
Research Hypotheses Hypothesis 1 (H1): H1: The knowledge level of nursing students who received simulation training with standardised patient is higher in isolated patient care training.
Hypothesis 2 (H2): Nursing students who received simulation training with standardised patient have higher skill level in isolated patient care training.
Hypothesis 3 (H3): The satisfaction of nursing students who received simulation training with standardised patient is higher in isolated patient care training.
Population and Sample of the Study: The population of the study consisted of the senior students of a foundation university in Istanbul (N=110). The study was conducted in the spring term of the 2022-2023 academic year within the scope of the 'Nursing Principles' course. Power analysis was performed to determine the number of people to be included in the study. As a similar study in the related literature, Park & Kim (2020) calculated the effect size for the difference in knowledge level as 0.857 in the study (28). In order to exceed the 95% value in determining the power of the study, it was determined that 62 people (df=60; t=1.671), including 31 people in groups with a significance level of 5% and an effect size of 0.857, should be reached. Considering the high power of the test and the losses in the study, a total of 80 students (40 experimental; 40 control) were reached.
Data Collection Tools: The data were collected using "The Student Information Form", "Knowledge Test on Isolated Patient Care', "Skills Assessment Form for Isolated Patient Care" and "Satisfaction Survey on Training Methods".
Analysis of Data: The data obtained in the study were analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 software. Number, percentage, mean, standard deviation were used as descriptive statistical methods in the evaluation of the data. Kurtosis and Skewness values were analysed to determine whether the research variables were normally distributed. In the related literature, the results of kurtosis and skewness values of the variables between +1.5 and -1.5 (32), +2.0 and -2.0 (33) are accepted as normal distribution. It was determined that the variables were normally distributed. Differences between the rates of categorical variables in independent groups were analysed with Chi-Square and Fisher exact tests. T-test was used to compare quantitative continuous data between two independent groups. Dependent groups t-test was used for comparison of intra-group measurements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beykent
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Istanbul, Beykent, Turkey, 34500
- Beykent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be between the ages 18-30
- Agreeing to participate in the study
- Being able to participate in the training and its implementation
Exclusion Criteria:
- not between the ages 18-30
- Lack of consent to participate in the study
- Absence from education and practice during the study period
- Request to leave during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Traditional Training Group
Students in the control group were taken to the laboratory practice within one week after the training presentation.
Students were expected to act in accordance with the skills of isolation precautions in line with the 'Sample Scenario'.
The individual in this scenario was an individual who was diagnosed with Covid-19 and suffered from anxiety due to isolation and neglected some rules.
The performance of the students was evaluated with the Skill Evaluation Form for Isolated Patient Care.
The students were asked to fill out the 'Satisfaction Survey on Training Methods' at the end of the application.
Their opinions and suggestions regarding the training they attended were also taken.
|
Students in the control group were taken to the laboratory practice within one week after the training presentation.
Students were expected to act in accordance with the skills of isolation precautions in line with the 'Sample Scenario'.
Other Names:
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Experimental: Training Group for Standardised Patient Simulation
One week after the training presentation, the experimental group was invited to the simulation training.
Simulation training was carried out in a hospital environment.
Materials to be used in standardised patient and isolated patient care were made available in the room.
The students were introduced to the field, scenario information on the subject and general principle frameworks.
Students were included in groups in the simulation training created in line with the 'Simulation Scenario'.
The scenario was prepared in line with the Healthcare Simulation Standards of Best PracticeTM of the International Nursing Association for Clinical Simulation and Learning (INACSL) standards (31) and submitted for expert opinion.
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One week after the training presentation, the experimental group was invited to the simulation training.
Simulation training was carried out in a hospital environment.
Materials to be used in standardised patient and isolated patient care were made availa
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skill Evaluation Form for Isolated Patient Care
Time Frame: 2 months
|
This form was developed in accordance with the isolation precautions guideline of the CDC.
The form includes 20 skill steps to be completed regarding isolation precautions.
The skills included communication, isolation measures and scenario-specific care steps.
The range of points that can be obtained from the form is between 0-100.
|
2 months
|
|
Knowledge Test on Isolated Patient Care
Time Frame: 2 Months
|
There are 20 questions in the form created by the researchers in line with the literature.
The scope of the questions included communication with the patient, use of protective equipment, hand washing and care practices.
The range of points that can be obtained from the form is between 0-100.
|
2 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Survey for Training Methods
Time Frame: 2 Months
|
The satisfaction survey on Training Methods was developed by Gürpınar (Cronbach's alpha: 0.84) and used in his studies .
The survey consists of 16 propositions.
Each proposition is scored according to a 5-point Likert scale (1 - strongly disagree, 2 - disagree, 3 - undecided, 4 - agree, 5 - strongly agree).
It was determined that the higher the mean score of the scale, the higher the students' satisfaction with the training method, and the lower the mean score of the scale, the lower their satisfaction with the training method.
In the evaluation of the scale, students' satisfaction with the Training Methods is scored at least 16 and at most 80 points.
|
2 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamiyet Kızıl, PhD, Beykent University
Publications and helpful links
General Publications
- Kim E, Kim SS, Kim S. Effects of Infection Control Education for Nursing Students Using Standardized Patients vs. Peer Role-Play. Int J Environ Res Public Health. 2020 Dec 26;18(1):107. doi: 10.3390/ijerph18010107.
- Bouget Mohammedi S, Landelle C. Review of literature: Knowledge and practice of standard precautions by nursing student and teaching techniques used in training. Am J Infect Control. 2023 May;51(5):574-581. doi: 10.1016/j.ajic.2022.08.032. Epub 2022 Sep 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-3 (Other Grant/Funding Number: Programme de subvention de recherche de la Fédération des médecins résidents du Québec)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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