SimulationNCT05302635
The Effect of Simulation-based Training on Nursing Students
A study testing Simulated group in people with Simulation and Education, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
This research will be carried out with the aim of making this practice practical with simulation-based training and improving cognitive, affective and psychomotor skills, and then applying it in the clinic, before applying the nasogastric tube placement application, which is included in enteral nutrition, to the child… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation, Education, Learning
- What is being tested?
- Simulated group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2022to 1 Nov 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Studying in the 3rd year of the Faculty of Health Sciences, Nursing Department of Yüksek İhtisas University and Biruni University,
- Having successfully completed the clinical application of the Fundamentals of Nursing course, Internal Medicine Nursing course and Surgical Diseases Nursing course and not repeating the grade,
- Those who will take the Child Health and Diseases Nursing course for the first time,
- Students who volunteer to participate in the research will be included.
Who cannot join
- Having received training on enteral nutrition in children,
- Simulation training,
- Students coming from other health departments (such as anaesthesia, laboratory technician, elderly health personnel) or from health vocational high schools as nursing will be excluded.
- Students who want to exit the research at any stage of the research will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation-based Training in Nasogastric Tube Application in Children on the Clinical Skills of Nursing Students: An Experimental Study
This research will be carried out with the aim of making this practice practical with simulation-based training and improving cognitive, affective and psychomotor skills, and then applying it in the clinic, before applying the nasogastric tube placement application, which is included in enteral nutrition, to the child in the clinic.
Read the detailed description
The fact that children react according to their age and cannot be considered separately from their families makes it difficult for nurse students to apply to the child group. When it comes to interventions that may cause stress/pain/discomfort, it can be even more difficult to manage the reactions of the child and family. By using the simulation method, the problems that make this type of teaching difficult can be reduced.For this reason, the aim of this study is for student nurses to make this practice practical with simulation-based training and to develop cognitive, affective and psychomotor skills before applying nasogastric tube placement, which is included in enteral nutrition, to a real child in the clinic, and then to apply it in the clinic.
- Conditions
- Simulation, Education, Learning, Clinical Skills, Child
- Being tested
- Simulated group
- Keywords
- Simulation, Nursing student, Clinical skills, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated groupOther
Students will be given training on nasogastic tube insertion and practice will be demonstrated in the laboratory based on the demonstration method and checklists, and will continue until students learn. Forms will be applied to students as a pre-test. A pilot scenario will be applied to two volunteer fourth year students.
Prebriefing: Students will be informed. Students will implement the scenario in the simulation laboratory and will wear uniforms. The student will be given 5 minutes for preparation, the application will be taken one by one and 15 minutes will be given for practice. Researchers will only observe during this time. During the application, the student will be scored according to the checklist. Students will be recorded with video.
Debriefing: Immediately after the end of the scenario, a debriefing session will be held with groups of 5 people. Feedback will be given on students' performance. Each session will last 20-30 minutes. Students will be given a post-test.
| Study group | Role | What they receive |
|---|---|---|
| Simulated group | Experimental | Students will be given training on nasogastic tube insertion and practice will be demonstrated in the laboratory based on the demonstration method and checklists, and will continue until students learn. Forms will be applied to students as a pre-test. A pilot scenario will be applied to two volunteer fourth year students.
Prebriefing: Students will be informed. Students will implement the scenario in the simulation laboratory and will wear uniforms. The student will be given 5 minutes for preparation, the application will be taken one by one and 15 minutes will be given for practice. Researchers will only observe during this time. During the application, the student will be scored according to the checklist. Students will be recorded with video.
Debriefing: Immediately after the end of the scenario, a debriefing session will be held with groups of 5 people. Feedback will be given on students' performance. Each session will last 20-30 minutes. Students will be given a post-test. Receives: Other: Simulated group |
| Control group | No intervention | Students will be given training on nasogastric tube insertion and nasogastric tube application will be demonstrated with the demonstration method in the laboratory and will continue until students learn. Forms will be applied to students as a pre-test. A pilot scenario will be applied to two volunteer fourth year students. Prebriefing: Students will be informed. Students will apply the scenario on the model in the skill laboratory and will wear uniforms. The student will be given 5 minutes for preparation. Students will be taken to the application one by one and 15 minutes of practice time will be given. During the application, the student will be scored according to the checklist. Students will be recorded with video. Debriefing: Immediately after the end of the scenario, a debriefing session will be held with groups of 5 people. Feedback will be given on students' performance in the debriefing session. Each session will last 20-30 minutes. Students will be given a post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy - Competence Scale
The scale was developed by Sherer et al. (1982). The scale, which does not belong to any subjective domain, measures the general perception of self-efficacy - efficacy. The scale consists of 23 items and four subscales. The subscales of the scale are respectively; These are "beginning the behavior", "maintaining the behavior", "Completing the behavior" and "Combating the obstacles". For each item; It is a five-point Likert-type scale as 1 = does not describe me at all, 2 = describes me a little, 3 = is undecided, 4 = describes me well, 5 = describes me very well. A score between 23 and 115 can be obtained from the scale. A high total score from the scale indicates that the individual's self-efficacy-efficacy perception is at a good level. The validity and reliability of the Turkish version of the scale was performed by Gözüm and Aksayan (1999).
Measured: immediately after training on nasogastic tube insertion and practice in the laboratory
Student Satisfaction and Self-Confidence Scale in Learning
The scale was developed by Jeffries and Rizzolo (2006) as 13 items to measure students' simulation activity and self-confidence in learning. Answering the scale for each item; 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Strongly Agree (Franklin et al., 2014). The Turkish validity and reliability study of the scale was carried out by Unver et al. (2017) and the total number of items decreased to 12.
Measured: immediately after the debriefing session
Clinical Decision Making Scale in Nursing
The Nursing Clinical Decision Making Scale was developed by Jenkins (1983) for nursing students. This scale defines how nursing students perceive clinical decision making based on their own statements. The scale consists of 40 items and four subscales. The subscales of the scale are respectively; These are "Exploring options and ideas", "Exploring goals and values", "Evaluating results", and "Searching for information and adopting new information objectively". Each subscale consists of 10 items. Each item of the scale is evaluated as 5=Always, 4=Often, 3=Sometimes, 2=Rarely, 1=Never. A high score from the scale indicates a high perception of decision making (Jenkins, 1983; Jenkins, 2001). The Turkish validity and reliability of the scale was done by Durmaz Edeer and Sarıkaya (2015).
Measured: immediately after training on nasogastic tube insertion and practice in the laboratory
Nasogastric Tube Placement Checklist
The Child Checklist was prepared by the researchers based on the literature (Bindler et al., 2014). The skill performance of the student will be evaluated over a total of 100 points, by scoring each application step according to the degree of importance.
Measured: During the application (experimental group= in the simulation laboratory; control group= in the skill laboratory
Secondary outcomes (2)
Self-Efficacy - Competence Scale
The scale was developed by Sherer et al. (1982). The scale, which does not belong to any subjective domain, measures the general perception of self-efficacy - efficacy. The scale consists of 23 items and four subscales. The subscales of the scale are respectively; These are "beginning the behavior", "maintaining the behavior", "Completing the behavior" and "Combating the obstacles". For each item; It is a five-point Likert-type scale as 1 = does not describe me at all, 2 = describes me a little, 3 = is undecided, 4 = describes me well, 5 = describes me very well. A score between 23 and 115 can be obtained from the scale. A high total score from the scale indicates that the individual's self-efficacy-efficacy perception is at a good level. The validity and reliability of the Turkish version of the scale was performed by Gözüm and Aksayan (1999).
Measured: immediately after the debriefing session
Clinical Decision Making Scale in Nursing
The Nursing Clinical Decision Making Scale was developed by Jenkins (1983) for nursing students. This scale defines how nursing students perceive clinical decision making based on their own statements. The scale consists of 40 items and four subscales. The subscales of the scale are respectively; These are "Exploring options and ideas", "Exploring goals and values", "Evaluating results", and "Searching for information and adopting new information objectively". Each subscale consists of 10 items. Each item of the scale is evaluated as 5=Always, 4=Often, 3=Sometimes, 2=Rarely, 1=Never. A high score from the scale indicates a high perception of decision making (Jenkins, 1983; Jenkins, 2001). The Turkish validity and reliability of the scale was done by Durmaz Edeer and Sarıkaya (2015).
Measured: immediately after the debriefing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start4 Apr 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimulationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde CALIKUSU Incekar, Yuksek Ihtisas University
- Investigators
- Sevim SAVAŞER, PhD, Principal investigator, Biruni UniversityHülya ZENGİN, PhD, Principal investigator, Yuksek Ihtisas UniversityGizem KAYA, MsC, Principal investigator, Biruni UniversityBahar ON, MsC, Principal investigator, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302635
- Sponsor's protocol ID
- YIU-M-CI-002
- Status last verified
- Dec 2022
- First submitted
- 13 Feb 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-based Training in Nasogastric Tube Application in Children on the Clinical Skills of Nursing Students: An Experimental Study
- ClinicalTrials.gov ID
- NCT05302635
- Acronym / sponsor ID
- YIU-M-CI-002
- Conditions
- Simulation, Education, Learning, Clinical Skills, Child
- Keywords
- Simulation, Nursing student, Clinical skills, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 31 Mar 2022 (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.
This research will be carried out with the aim of making this practice practical with simulation-based training and improving cognitive, affective and psychomotor skills, and then applying it in the clinic, before applying the nasogastric tube placement application, which is included in enteral nutrition, to the child in the clinic.
Detailed description
The fact that children react according to their age and cannot be considered separately from their families makes it difficult for nurse students to apply to the child group. When it comes to interventions that may cause stress/pain/discomfort, it can be even more difficult to manage the reactions of the child and family. By using the simulation method, the problems that make this type of teaching difficult can be reduced.For this reason, the aim of this study is for student nurses to make this practice practical with simulation-based training and to develop cognitive, affective and psychomotor skills before applying nasogastric tube placement, which is included in enteral nutrition, to a real child in the clinic, and then to apply it in the clinic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulated group | Experimental | Other: Simulated groupStudents will be given training on nasogastic tube insertion and practice will be demonstrated in the laboratory based on the demonstration method and checklists, and will continue until students learn. Forms will be applied to students as a pre-test. A pilot scenario will be applied to two volunteer fourth year students. Prebriefing: Students will be informed. Students will implement the scenario in the simulation laboratory and will wear uniforms. The student will be given 5 minutes for preparation, the application will be taken one by one and 15 minutes will be given for practice. Researchers will only observe during this time. During the application, the student will be scored according to the checklist. Students will be recorded with video. Debriefing: Immediately after the end of the scenario, a debriefing session will be held with groups of 5 people. Feedback will be given on students' performance. Each session will last 20-30 minutes. Students will be given a post-test. |
| Control group | No intervention | –Students will be given training on nasogastric tube insertion and nasogastric tube application will be demonstrated with the demonstration method in the laboratory and will continue until students learn. Forms will be applied to students as a pre-test. A pilot scenario will be applied to two volunteer fourth year students. Prebriefing: Students will be informed. Students will apply the scenario on the model in the skill laboratory and will wear uniforms. The student will be given 5 minutes for preparation. Students will be taken to the application one by one and 15 minutes of practice time will be given. During the application, the student will be scored according to the checklist. Students will be recorded with video. Debriefing: Immediately after the end of the scenario, a debriefing session will be held with groups of 5 people. Feedback will be given on students' performance in the debriefing session. Each session will last 20-30 minutes. Students will be given a post-test. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Studying in the 3rd year of the Faculty of Health Sciences, Nursing Department of Yüksek İhtisas University and Biruni University,
- Having successfully completed the clinical application of the Fundamentals of Nursing course, Internal Medicine Nursing course and Surgical Diseases Nursing course and not repeating the grade,
- Those who will take the Child Health and Diseases Nursing course for the first time,
- Students who volunteer to participate in the research will be included.
Key exclusion criteria (4 listed)
- Having received training on enteral nutrition in children,
- Simulation training,
- Students coming from other health departments (such as anaesthesia, laboratory technician, elderly health personnel) or from health vocational high schools as nursing will be excluded.
- Students who want to exit the research at any stage of the research will be excluded from the research.
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 |
|---|---|---|
| Simulated groupStudents will be given training on nasogastic tube insertion and practice will be demonstrated in the laboratory based on the demonstration method and checklists, and will continue until students learn. Forms will be applied to students as a pre-test. A pilot scenario will be applied to two volunteer fourth year students. Prebriefing: Students will be informed. Students will implement the scenario in the simulation laboratory and will wear uniforms. The student will be given 5 minutes for preparation, the application will be taken one by one and 15 minutes will be given for practice. Researchers will only observe during this time. During the application, the student will be scored according to the checklist. Students will be recorded with video. Debriefing: Immediately after the end of the scenario, a debriefing session will be held with groups of 5 people. Feedback will be given on students' performance. Each session will last 20-30 minutes. Students will be given a post-test. | Other | Simulated group |
Primary outcome
Self-Efficacy - Competence Scale
Time frame: immediately after training on nasogastic tube insertion and practice in the laboratory
The scale was developed by Sherer et al. (1982). The scale, which does not belong to any subjective domain, measures the general perception of self-efficacy - efficacy. The scale consists of 23 items and four subscales. The subscales of the scale are respectively; These are "beginning the behavior", "maintaining the behavior", "Completing the behavior" and "Combating the obstacles". For each item; It is a five-point Likert-type scale as 1 = does not describe me at all, 2 = describes me a little, 3 = is undecided, 4 = describes me well, 5 = describes me very well. A score between 23 and 115 can be obtained from the scale. A high total score from the scale indicates that the individual's self-efficacy-efficacy perception is at a good level. The validity and reliability of the Turkish version of the scale was performed by Gözüm and Aksayan (1999).
Student Satisfaction and Self-Confidence Scale in Learning
Time frame: immediately after the debriefing session
The scale was developed by Jeffries and Rizzolo (2006) as 13 items to measure students' simulation activity and self-confidence in learning. Answering the scale for each item; 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, 5=Strongly Agree (Franklin et al., 2014). The Turkish validity and reliability study of the scale was carried out by Unver et al. (2017) and the total number of items decreased to 12.
Clinical Decision Making Scale in Nursing
Time frame: immediately after training on nasogastic tube insertion and practice in the laboratory
The Nursing Clinical Decision Making Scale was developed by Jenkins (1983) for nursing students. This scale defines how nursing students perceive clinical decision making based on their own statements. The scale consists of 40 items and four subscales. The subscales of the scale are respectively; These are "Exploring options and ideas", "Exploring goals and values", "Evaluating results", and "Searching for information and adopting new information objectively". Each subscale consists of 10 items. Each item of the scale is evaluated as 5=Always, 4=Often, 3=Sometimes, 2=Rarely, 1=Never. A high score from the scale indicates a high perception of decision making (Jenkins, 1983; Jenkins, 2001). The Turkish validity and reliability of the scale was done by Durmaz Edeer and Sarıkaya (2015).
Nasogastric Tube Placement Checklist
Time frame: During the application (experimental group= in the simulation laboratory; control group= in the skill laboratory
The Child Checklist was prepared by the researchers based on the literature (Bindler et al., 2014). The skill performance of the student will be evaluated over a total of 100 points, by scoring each application step according to the degree of importance.
2 secondary outcomes
Self-Efficacy - Competence Scale
Time frame: immediately after the debriefing session
Clinical Decision Making Scale in Nursing
Time frame: immediately after the debriefing session
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 27 Dec 2022.
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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.
Sevim SAVAŞER, PhD principal investigator
Biruni University
Hülya ZENGİN, PhD principal investigator
Yuksek Ihtisas University
Gizem KAYA, MsC principal investigator
Biruni 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 Simulated group in people with Simulation and Education, run by Yuksek Ihtisas University 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 4 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 27 Dec 2022. 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?
Self-Efficacy - Competence Scale (time frame: immediately after training on nasogastic tube insertion and practice in the laboratory). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2022.