Simulation-based LearningNCT07512414
Simulation-based Pediatric Nursing Laboratory Education
A study testing Simulation based education and classic education in people with Simulation-based Learning and Nursing Education Research, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effect of a simulation-based laboratory program in the pediatric nursing course on students' pediatric nursing competency levels and their levels of clinical anxiety and comfort. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simulation-based Learning, Nursing Education Research
- What is being tested?
- Simulation based education and classic education
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 6 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being a third-year nursing student,
- Not having previously taken the Pediatric Nursing course,
- Not having practiced in pediatric clinics,
- Not being a graduate of a health vocational high school,
- Volunteering to participate in the study.
Who cannot join
- Not participating in the laboratory practice,
- Not completing all forms to be used in the study,
- Withdrawing from the study at any stage,
- Working as a nurse.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Atakum, 55200
About this study
Official title: The Effects of Simulation-based Pediatric Nursing Laboratory Education on Nursing Students' Clinical Competence, Self-efficacy, and Anxiety: A Randomized Controlled Trial
This study aimed to examine the effect of a simulation-based laboratory program in the pediatric nursing course on students' pediatric nursing competency levels and their levels of clinical anxiety and comfort.
Read the detailed description
Student nurses experience significant anxiety and concern in clinical practice. Particularly in the clinical application of pediatric nursing courses, students are more worried about harming children or making mistakes when calculating medication dosages. It is essential to enhance students' self-confidence in pediatric nursing, support them in acquiring competencies specific to the field, and foster their teamwork skills. Simulation, an innovative interactive method in nursing education, provides students with a realistic learning environment where they experience real-life situations through scenarios, offering opportunities to develop their cognitive, psychomotor, and behavioral knowledge and skills.
- Being tested
- Simulation based education, classic education
- Keywords
- Anxiety, Simulation-based education, Nursing students, Pediatric nursing education, Clinical competence
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based educationOther
Introduction, warm-up, and presentation of the training program (30 min.), taking vital signs in infants and children (45 min.), meeting the hygiene needs of newborns/children (oral care, umbilical cord care, body bathing, perineal cleaning) (45 min.), pediatric nursing care skills (taking blood and urine samples from infants and children, oxygen administration) (45 min.), and pediatric medication preparation and administration skills (oral, IM, IV medication preparation and administration) (45 min.). Each laboratory skill for the course is organized as 45 min of training and a 15-min break. Each skill was demonstrated to students by researchers individually on a simulation model according to cases prepared for simulation within the time allocated to it. Subsequently, the procedures within the case were performed piece by piece by different students under the guidance of a researcher, and feedback was provided on any missing or incorrect points.
classic educationOther
Introduction, warm-up, and presentation of the training program (30 min.), taking vital signs in infants and children (45 min.), meeting the hygiene needs of newborns/children (oral care, umbilical cord care, body bathing, cleaning the lower body) (45 min.), pediatric nursing care skills (taking blood and urine samples from infants and children, oxygen administration) (45 min.), and pediatric medication preparation and administration skills (oral, IM, IV medication preparation and administration) (45 min.). Each laboratory skill for the course was organized into 45 minutes of instruction and a 15-minute break, using student-centered active learning methods such as lecturing, discussion, video viewing, individual work, question-and-answer sessions, and brainstorming as teaching techniques.
| Study group | Role | What they receive |
|---|---|---|
| Simulation based education | Experimental | Inclusion Criteria:
* Being a third-year nursing student,
* Not having previously taken the Pediatric Nursing course,
* Not having practiced in pediatric clinics,
* Not being a graduate of a health vocational high school,
* Volunteering to participate in the study.
Exclusion Criteria:
* Not participating in the laboratory practice,
* Not completing all forms to be used in the study,
* Withdrawing from the study at any stage,
* Working as a nurse Receives: Other: Simulation based education |
| Classic education | Other | Inclusion Criteria:
* Being a third-year nursing student,
* Not having previously taken the Pediatric Nursing course,
* Not having practiced in pediatric clinics,
* Not being a graduate of a health vocational high school,
* Volunteering to participate in the study.
Exclusion Criteria:
* Not participating in the laboratory practice,
* Not completing all forms to be used in the study,
* Withdrawing from the study at any stage,
* Working as a nurse Receives: Other: classic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Competence
The primary outcome of the study was perceived pediatric nursing competence. Pediatric Nursing Competency Scale was used for evaluation.
Bektas et al. (2000) developed this scale to assess nursing students' competency in pediatric nursing. The scale consists of 39 items across eight subscales. The items on the five-point Likert scale are answered as follows: 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree. The Cronbach's alpha reliability coefficient was found to be higher than 0.80 for the scale and its subdimensions. The lowest possible score on the scale is 39, and the highest possible score is 195. It is thought that as the score on the scale increases, students' pediatric nursing competence increases (Bektas et al., 2020).
Measured: 8 hours
Secondary outcomes (1)
clinical comfort, anxiety
The secondary outcomes included self-efficacy, clinical comfort, anxiety, and attitudes toward vital signs monitoring. The following tools were used in the study: Vital Signs Scale (V-Scale), developed initially by Mok et al. (2015), was further adapted to Turkish by Ertug (2018) (Ertug, 2018; Mok et al., 2015).
Self-Efficacy Scale for Nursing Students in Medication Administration in Children:
The scale was developed by Bektaş et al. based on pediatric medication administration guidelines and studies conducted in the literature on medication administration in children by nursing students.
Pediatric Nursing Student Clinical Comfort and Anxiety Assessment Tool:
Al-Qaaydeh \& Lassche Macintosh (2012) first developed this tool to determine the comfort and anxiety levels of nursing students entering the pediatric clinic for the first time (Al-Qaaydeh et al., 2012). Arslan et al. (2018) conducted a study on the validity and reliability of the scale in Turkish.
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start15 Apr 2024
- Primary completion22 Apr 2024
- Study completion6 May 2024
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 Simulation-based LearningStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a single-center, parallel-group randomized controlled trial with a pretest-posttest design.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Koyun, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512414
- Sponsor's protocol ID
- 27.01.2023, 2023-1295
- Status last verified
- Mar 2026
- First submitted
- 27 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: other researhers may view the study once it is published.
Publications
Al-Qaaydeh S, Lassche M, Macintosh CI. Exploratory factor analysis of the pediatric nursing student clinical comfort and worry assessment tool. J Pediatr Nurs. 2012 Oct;27(5):e39-43. doi: 10.1016/j.pedn.2012.05.003. Epub 2012 Jun 15.
PubMed 22710150Akdeniz Kudubes A, Zengin H, Ayar D, Bektas IL, Bektas M. The Effect of Nursing Students' Liking of Children and Attitudes Toward Clinical Practice on Their Comfort and Worry Levels in the Pediatric Clinic. Compr Child Adolesc Nurs. 2024 Mar;47(1):31-43. doi: 10.1080/24694193.2023.2269264. Epub 2024 Feb 8.
PubMed 37847558
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Simulation-based Pediatric Nursing Laboratory Education on Nursing Students' Clinical Competence, Self-efficacy, and Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07512414
- Acronym / sponsor ID
- 27.01.2023, 2023-1295
- Keywords
- Anxiety, Simulation-based education, Nursing students, Pediatric nursing education, Clinical competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 6 Apr 2026 (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 study aimed to examine the effect of a simulation-based laboratory program in the pediatric nursing course on students' pediatric nursing competency levels and their levels of clinical anxiety and comfort.
Detailed description
Student nurses experience significant anxiety and concern in clinical practice. Particularly in the clinical application of pediatric nursing courses, students are more worried about harming children or making mistakes when calculating medication dosages. It is essential to enhance students' self-confidence in pediatric nursing, support them in acquiring competencies specific to the field, and foster their teamwork skills. Simulation, an innovative interactive method in nursing education, provides students with a realistic learning environment where they experience real-life situations through scenarios, offering opportunities to develop their cognitive, psychomotor, and behavioral knowledge and skills.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a single-center, parallel-group randomized controlled trial with a pretest-posttest design.
| Arm | Type | Receives |
|---|---|---|
| Simulation based education | Experimental | Other: Simulation based educationInclusion Criteria: * Being a third-year nursing student, * Not having previously taken the Pediatric Nursing course, * Not having practiced in pediatric clinics, * Not being a graduate of a health vocational high school, * Volunteering to participate in the study. Exclusion Criteria: * Not participating in the laboratory practice, * Not completing all forms to be used in the study, * Withdrawing from the study at any stage, * Working as a nurse |
| Classic education | Other | Other: classic educationInclusion Criteria: * Being a third-year nursing student, * Not having previously taken the Pediatric Nursing course, * Not having practiced in pediatric clinics, * Not being a graduate of a health vocational high school, * Volunteering to participate in the study. Exclusion Criteria: * Not participating in the laboratory practice, * Not completing all forms to be used in the study, * Withdrawing from the study at any stage, * Working as a nurse |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being a third-year nursing student,
- Not having previously taken the Pediatric Nursing course,
- Not having practiced in pediatric clinics,
- Not being a graduate of a health vocational high school,
- Volunteering to participate in the study.
Key exclusion criteria (4 listed)
- Not participating in the laboratory practice,
- Not completing all forms to be used in the study,
- Withdrawing from the study at any stage,
- Working as a nurse.
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 |
|---|---|---|
| Simulation based educationIntroduction, warm-up, and presentation of the training program (30 min.), taking vital signs in infants and children (45 min.), meeting the hygiene needs of newborns/children (oral care, umbilical cord care, body bathing, perineal cleaning) (45 min.), pediatric nursing care skills (taking blood and urine samples from infants and children, oxygen administration) (45 min.), and pediatric medication preparation and administration skills (oral, IM, IV medication preparation and administration) (45 min.). Each laboratory skill for the course is organized as 45 min of training and a 15-min break. Each skill was demonstrated to students by researchers individually on a simulation model according to cases prepared for simulation within the time allocated to it. Subsequently, the procedures within the case were performed piece by piece by different students under the guidance of a researcher, and feedback was provided on any missing or incorrect points. | Other | Simulation based education |
| classic educationIntroduction, warm-up, and presentation of the training program (30 min.), taking vital signs in infants and children (45 min.), meeting the hygiene needs of newborns/children (oral care, umbilical cord care, body bathing, cleaning the lower body) (45 min.), pediatric nursing care skills (taking blood and urine samples from infants and children, oxygen administration) (45 min.), and pediatric medication preparation and administration skills (oral, IM, IV medication preparation and administration) (45 min.). Each laboratory skill for the course was organized into 45 minutes of instruction and a 15-minute break, using student-centered active learning methods such as lecturing, discussion, video viewing, individual work, question-and-answer sessions, and brainstorming as teaching techniques. | Other | Classic education |
Primary outcome
Competence
Time frame: 8 hours
The primary outcome of the study was perceived pediatric nursing competence. Pediatric Nursing Competency Scale was used for evaluation. Bektas et al. (2000) developed this scale to assess nursing students' competency in pediatric nursing. The scale consists of 39 items across eight subscales. The items on the five-point Likert scale are answered as follows: 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree. The Cronbach's alpha reliability coefficient was found to be higher than 0.80 for the scale and its subdimensions. The lowest possible score on the scale is 39, and the highest possible score is 195. It is thought that as the score on the scale increases, students' pediatric nursing competence increases (Bektas et al., 2020).
1 secondary outcome
clinical comfort, anxiety
Time frame: 16 hours
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 6 Apr 2026.
- Results publication: PubMed 22710150Al-Qaaydeh S, Lassche M, Macintosh CI. Exploratory factor analysis of the pediatric nursing student clinical comfort and worry assessment tool. J Pediatr Nurs. 2012 Oct;27(5):e39-43. doi: 10.1016/j.pedn.2012.05.003. Epub 2012 Jun 15.
- Results publication: PubMed 37847558Akdeniz Kudubes A, Zengin H, Ayar D, Bektas IL, Bektas M. The Effect of Nursing Students' Liking of Children and Attitudes Toward Clinical Practice on Their Comfort and Worry Levels in the Pediatric Clinic. Compr Child Adolesc Nurs. 2024 Mar;47(1):31-43. doi: 10.1080/24694193.2023.2269264. Epub 2024 Feb 8.
- Individual participant dataSharing planned: No. other researhers may view the study once it is published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation based education and classic education in people with Simulation-based Learning and Nursing Education Research, run by Ondokuz Mayıs 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 5 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 6 Apr 2026. 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?
Competence (time frame: 8 hours). 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 NCT07512414, 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 6 Apr 2026.