- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512414
Simulation-based Pediatric Nursing Laboratory Education
The Effects of Simulation-based Pediatric Nursing Laboratory Education on Nursing Students' Clinical Competence, Self-efficacy, and Anxiety: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Atakum
-
Samsun, Atakum, Turkey (Türkiye), 55200
- Ondokuz Mayıs University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Simulation based education
Inclusion Criteria:
Exclusion Criteria:
|
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.
|
|
Other: Classic education
Inclusion Criteria:
Exclusion Criteria:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical comfort, anxiety
Time Frame: 16 hours
|
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. |
16 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Al-Qaaydeh, S., Lassche, M., & Macintosh, C. (2012). Exploratory factor analysis of the pediatric nursing student clinical comfort and worry assessment tool. Journal of Pediatric Nursing, 27(5), 39-43. DOI: 10.1016/j.pedn.2012.05.003.
- Akdeniz Kudubes, A., Zengin, H., Ayar, D., Bektas, I., & Bektas, M. (2024). The effect of nursing students' liking of children and attitudes toward clinical practice on their comfort and worry levels in the pediatric clinic. Comprehensive Child and Adolescent Nursing, 47(1), 31-43. DOI: 10.1080/24694193.2023.2269264
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27.01.2023, 2023-1295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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