Nursing CariesNCT06566924
The Effect of Standardised Patient Simulation in Nursing Education
A study testing Training Group for Standardised Patient Simulation in people with Nursing Caries, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
With the coronavirus outbreak, the experience of nursing students with personal protective equipment is one of the issues of interest. The competence of nursing students is important in terms of the fact that outbreaks will persist in the future. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Training Group for Standardised Patient Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between the ages 18-30
- Agreeing to participate in the study
- Being able to participate in the training and its implementation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Standardised Patient Simulation on Nursing Students' Knowledge, Skills and Satisfaction in Isolated Patient Care
With the coronavirus outbreak, the experience of nursing students with personal protective equipment is one of the issues of interest. The competence of nursing students is important in terms of the fact that outbreaks will persist in the future. In this study, the effect of standardised patient method in training of isolated patient care in terms of knowledge, skills and satisfaction of nursing students was investigated. A experimental design was employed in this study, involving a total of 80 nursing university students, with 40 participants in the experimental group and 40 in the control group. In the study, pre-test-post-test knowledge exam, isolated patient care skills and training satisfaction of nursing students were evaluated. In addition to descriptive statistical methods, chi-square, fisher exact and t-tests were used in the evaluation of the data.
Read the 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.
- Conditions
- Nursing Caries
- Being tested
- Control, Training Group for Standardised Patient Simulation
- Keywords
- Care, isolation, nursing, simulation, standardised patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called No intervention was performed
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'.
Training Group for Standardised Patient SimulationOther
Also called Before the training, the students were introduced to the field, scenario information on the subject and general principle frameworks
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
| Study group | Role | What they receive |
|---|---|---|
| Traditional Training Group | Experimental | 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. Receives: Other: Control |
| Training Group for Standardised Patient Simulation | Experimental | 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. Receives: Other: Training Group for Standardised Patient Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skill Evaluation Form for Isolated Patient Care
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.
Measured: 2 months
Knowledge Test on Isolated Patient Care
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.
Measured: 2 Months
Secondary outcomes (1)
Satisfaction Survey for Training Methods
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.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 Apr 2023
- Primary completion1 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamiyet KIZIL, University of Beykent
- Investigators
- Hamiyet Kızıl, PhD, Principal investigator, Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566924
- Sponsor's protocol ID
- 2023-3
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33375222Bouget 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.
PubMed 36075296
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Standardised Patient Simulation on Nursing Students' Knowledge, Skills and Satisfaction in Isolated Patient Care
- ClinicalTrials.gov ID
- NCT06566924
- Acronym / sponsor ID
- 2023-3
- Conditions
- Nursing Caries
- Keywords
- Care, isolation, nursing, simulation, standardised patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the coronavirus outbreak, the experience of nursing students with personal protective equipment is one of the issues of interest. The competence of nursing students is important in terms of the fact that outbreaks will persist in the future. In this study, the effect of standardised patient method in training of isolated patient care in terms of knowledge, skills and satisfaction of nursing students was investigated. A experimental design was employed in this study, involving a total of 80 nursing university students, with 40 participants in the experimental group and 40 in the control group. In the study, pre-test-post-test knowledge exam, isolated patient care skills and training satisfaction of nursing students were evaluated. In addition to descriptive statistical methods, chi-square, fisher exact and t-tests were used in the evaluation of the data.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Training Group | Experimental | Other: ControlStudents 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. |
| Training Group for Standardised Patient Simulation | Experimental | Other: Training Group for Standardised Patient SimulationOne 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- be between the ages 18-30
- Agreeing to participate in the study
- Being able to participate in the training and its implementation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: No intervention was performedStudents 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 | Traditional Training Group |
| Training Group for Standardised Patient SimulationAlso: Before the training, the students were introduced to the field, scenario information on the subject and general principle frameworksOne 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 | Training Group for Standardised Patient Simulation |
Primary outcome
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.
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.
1 secondary outcome
Satisfaction Survey for Training Methods
Time frame: 2 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Results publication: PubMed 33375222Kim 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.
- Results publication: PubMed 36075296Bouget 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamiyet Kızıl, PhD principal investigator
Beykent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Group for Standardised Patient Simulation in people with Nursing Caries, run by University of Beykent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skill Evaluation Form for Isolated Patient Care (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06566924, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.