An interventional study of Simulation-Based PEG Training and Traditional Demonstration-Based PEG Training in Nursing Education, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Ataturk University · Not applicable, Interventional, and Other
This randomized controlled trial aimed to compare the effects of simulation-based training and traditional demonstration-based training on knowledge and practical skills related to percutaneous endoscopic gastrostomy (PEG) care among first-year nursing students.
The study included 40 nursing students who were randomly assigned to two groups: a simulation-based training group (n=20) and a traditional training group (n=20). All participants received four hours of theoretical instruction on PEG care, enteral feeding, and medication administration. The simulation group then participated in a two-hour structured training session using a simulation mannequin and an interactive clinical scenario. The control group received a two-hour traditional demonstration-based laboratory session.
PEG-related knowledge was assessed before training and one week after the practical training sessions using a 25-item knowledge test. Practical skills were evaluated after training through an Objective Structured Clinical Examination (OSCE) using a 25-step skills checklist.
The study aimed to determine whether simulation-based training was more effective than traditional demonstration-based training in improving nursing students' knowledge and practical skills related to PEG care.
This study was conducted as a two-arm, parallel-group randomized controlled trial with a pretest-posttest design at a university nursing faculty in Türkiye during the spring semester of the 2025-2026 academic year.
The study population consisted of first-year undergraduate nursing students enrolled in the Fundamentals of Nursing course. Eligible students were aged 18 years or older, were taking the course for the first time, had no previous health-related educational background, and voluntarily provided written informed consent.
A total of 40 students were randomly assigned to the simulation-based training group (n=20) or the traditional demonstration-based training group (n=20). Random allocation was performed by an individual independent of the research team using a random numbers table. To reduce contamination between groups, practical training sessions were conducted at different times.
At baseline, participants completed a personal information form and a 25-item PEG Knowledge Test. All students subsequently received four hours of standardized theoretical instruction covering PEG care, enteral feeding, medication administration, stoma care, and prevention of complications.
The control group received a two-hour laboratory training session in which PEG care, feeding, and medication administration procedures were demonstrated using training models. No simulation-based scenarios were included.
The intervention group participated in a two-hour structured simulation-based training session conducted in a simulation laboratory. Students practiced PEG care, feeding, and medication administration using a simulation mannequin within an interactive clinical scenario.
One week after the practical training sessions, PEG-related knowledge was reassessed using the same 25-item knowledge test. The test was scored from 0 to 100, with higher scores indicating greater knowledge.
Practical skill performance was assessed using an Objective Structured Clinical Examination (OSCE) and a 25-step PEG Skills Checklist. Each step was scored as correctly performed (2 points), incompletely or incorrectly performed (1 point), or not performed (0 points), yielding a total score ranging from 0 to 50. Higher scores indicated better practical skill performance.
The instructors conducting the OSCE assessments were blinded to group allocation. Statistical analyses were performed by an independent statistician using masked group codes.
After completion of data collection, students in the control group were also offered simulation-based training to ensure equal educational opportunities.
Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group (n=20) received four hours of standardized theoretical instruction on percutaneous endoscopic gastrostomy (PEG) care, enteral feeding, and medication administration, followed by a two-hour structured simulation-based training session. The practical training was conducted in a simulation laboratory using a simulation mannequin and an interactive clinical scenario to develop PEG care and procedural skills.
Behavioral: Simulation-Based PEG Training
Participants in this group (n=20) received four hours of standardized theoretical instruction on PEG care, enteral feeding, and medication administration, followed by a two-hour traditional demonstration-based laboratory session. PEG care, feeding, and medication administration procedures were demonstrated using training models without simulation-based clinical scenarios. After completion of outcome assessments, participants were also offered simulation-based training.
Behavioral: Traditional Demonstration-Based PEG Training
Participants received four hours of standardized theoretical instruction on percutaneous endoscopic gastrostomy (PEG) care, enteral feeding, and medication administration. This was followed by a two-hour structured simulation-based training session conducted in a simulation laboratory. Students practiced PEG care, feeding, and medication administration using a simulation mannequin and an interactive clinical scenario designed to support clinical decision-making and practical skill development.
Participants received four hours of standardized theoretical instruction on PEG care, enteral feeding, and medication administration. This was followed by a two-hour traditional demonstration-based laboratory session. The instructor demonstrated PEG care, feeding, and medication administration procedures using training models. No simulation-based clinical scenarios were used during this session. After completion of all outcome assessments, participants were offered simulation-based training.
Change in PEG Care Knowledge Score
PEG-related knowledge was assessed using the researcher-developed 25-item Percutaneous Endoscopic Gastrostomy (PEG) Knowledge Test. Each correct answer was scored 4 points, and incorrect or unanswered items were scored 0 points. Total scores ranged from 0 to 100, with higher scores indicating better PEG-related knowledge. The outcome was the change in total knowledge score from baseline to one week after training.
Time frame: Baseline and one week after practical training
PEG Care Practical Skill Performance Score
Practical skill performance in percutaneous endoscopic gastrostomy (PEG) care was assessed using the researcher-developed 25-item PEG Care Skills Checklist during an Objective Structured Clinical Examination (OSCE). Each procedural step was scored as correctly performed (2 points), incompletely or incorrectly performed (1 point), or not performed (0 points). The 25 item scores were summed to obtain a single total score ranging from 0 to 50, with higher scores indicating better PEG care practical skill performance.
Time frame: One week after practical training
Plan to share: No — Individual participant data will not be shared publicly due to participant confidentiality and data privacy considerations. Only aggregated and anonymized study findings will be reported in scientific publications.
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