Nursing EducationNCT06195722
Developing a Simulation for Parenteral Drug Administration
A study testing simulation in people with Nursing Education and Cognitive Orientation, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
In the current Covid-19 pandemic process, distance education has become widespread and will continue to become widespread in the return to normal. In the distance education process, theoretical courses can be given with methods such as synchronous or asynchronous lectures, questions and answers, and discussion. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Education, Cognitive Orientation, Injection Site
- What is being tested?
- simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Aug 2025
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who have registered for the Fundamentals of Nursing II Course for the first time,
- Having a computer, tablet or smartphone,
- Having internet access,
- Volunteer to participate in the research
Who cannot join
- Having graduated from Health Vocational High School or studied a health-related department,
- Have any previous experience of basic nursing skills
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sule Biyik Bayram
Trabzon, Ortahisar, 61080
Emel GÜLNAR, phd, +903183573738, emelglnr@gmail.com
Nurcan ÇALIŞKAN, Phd
About this study
Official title: Karadeniz Technical University, Faculty of Health Sciences
In the current Covid-19 pandemic process, distance education has become widespread and will continue to become widespread in the return to normal. In the distance education process, theoretical courses can be given with methods such as synchronous or asynchronous lectures, questions and answers, and discussion. However, in departments such as the nursing department, where laboratory and clinical practice are given during the term, there are some difficulties in providing the practice with distance education. Since students cannot be in clinical practice, they cannot develop their basic nursing skills. However, it is not possible for students to develop their skills in distance education. In addition, due to the high number of students in face-to-face teaching and the low number of lecturers, the lecturer and students cannot spend enough and effective time in the laboratories. Because there are 50-60 students per lecturer and therefore students are not sufficient in basic nursing skills. In order for students to improve their skills, there are technological methods that allow students to try the application on their own, at the desired place and time, without risking patient safety, in virtual environments, without entering the laboratory. Simulation opportunities can be provided to students by creating environments, models, materials and patients similar to the real hospital environment in virtual environments. It is seen in the literature that similar studies have been carried out outside of our country and are used in nursing education. However, in our country, a similar application was made in the virtual environment only in the thesis study of the director. This thesis study, which is similar to this project study, only includes tracheostomy care skill, which is one of the basic nursing skills. This project will include simulation parenteral drug administration skills in our work. For this reason, it will be the first simulation prepared for parenteral drug applications in our country. Drug administration constitutes an important step in patient safety. Although this section is explained theoretically, students are not given sufficient opportunities to have different drug doses prepared and administered in the laboratory. For this reason, when the student encounters a complex situation in the clinic, the decision-making process is prolonged and the risk of making mistakes increases.
Read the detailed description
In this project study, it is aimed to determine the effect of simulation and teaching to be developed on the knowledge and skills of nursing students in drug administration. For this purpose, a scenario will be written for subcutaneous, intramuscular and intravenous drug administration skills and a simulation will be developed by simulating it in a virtual environment. After the students who accept to participate in the study, take the pre-test and OSCE exam on the subject, the experimental group students will administer the drugs on the virtual patient. After the students they use simulation, a notification will be sent to the researcher's mail address. Thus, it will be determined how many times the students use simulation. When the three-week probation period is over, students will be taken to the posttest and OSCE exam again. Control group students will only follow the laboratory trainings included in the traditional learning process
- Conditions
- Nursing Education, Cognitive Orientation, Injection Site
- Being tested
- simulation
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulationOther
parenteral drug simulation
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | control |
| experimental | Experimental | experimental Receives: Other: simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teaching parenteral drug administration through simulation has an effect on the knowledge test average score of nursing students.
Data will be collected through student identification characteristics form, Parenteral Drug Applications Knowledge Test.
Measured: 3 mounth
Secondary outcomes (1)
Teaching parenteral drug administration through simulation has an effect on the OSCE skill score average of nursing students.
Data will be collected through Drug Applications Skill Checklists
Measured: 3 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jul 2024 (estimated)
- Primary completion10 Aug 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sule BIYIK BAYRAM, Karadeniz Technical University
- Investigators
- Şule Bıyık Bayram, Study director, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195722
- Sponsor's protocol ID
- KaradenizTU-2
- Status last verified
- Jun 2024
- First submitted
- 12 Dec 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biyik Bayram S, Gulnar E, Caliskan N, Ozyurt H, Bayram A. The Effect of Virtual Simulation of Parenteral Medication Administration on Nursing Students' Knowledge and Skills: A Randomized Controlled Experimental Study. Comput Inform Nurs. 2026 Jun 10. doi: 10.1097/CIN.0000000000001581. Online ahead of print.
PubMed 42267610
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Karadeniz Technical University, Faculty of Health Sciences
- ClinicalTrials.gov ID
- NCT06195722
- Acronym / sponsor ID
- KaradenizTU-2
- Conditions
- Nursing Education, Cognitive Orientation, Injection Site
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 8 Jan 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.
In the current Covid-19 pandemic process, distance education has become widespread and will continue to become widespread in the return to normal. In the distance education process, theoretical courses can be given with methods such as synchronous or asynchronous lectures, questions and answers, and discussion. However, in departments such as the nursing department, where laboratory and clinical practice are given during the term, there are some difficulties in providing the practice with distance education. Since students cannot be in clinical practice, they cannot develop their basic nursing skills. However, it is not possible for students to develop their skills in distance education. In addition, due to the high number of students in face-to-face teaching and the low number of lecturers, the lecturer and students cannot spend enough and effective time in the laboratories. Because there are 50-60 students per lecturer and therefore students are not sufficient in basic nursing skills. In order for students to improve their skills, there are technological methods that allow students to try the application on their own, at the desired place and time, without risking patient safety, in virtual environments, without entering the laboratory. Simulation opportunities can be provided to students by creating environments, models, materials and patients similar to the real hospital environment in virtual environments. It is seen in the literature that similar studies have been carried out outside of our country and are used in nursing education. However, in our country, a similar application was made in the virtual environment only in the thesis study of the director. This thesis study, which is similar to this project study, only includes tracheostomy care skill, which is one of the basic nursing skills. This project will include simulation parenteral drug administration skills in our work. For this reason, it will be the first simulation prepared for parenteral drug applications in our country. Drug administration constitutes an important step in patient safety. Although this section is explained theoretically, students are not given sufficient opportunities to have different drug doses prepared and administered in the laboratory. For this reason, when the student encounters a complex situation in the clinic, the decision-making process is prolonged and the risk of making mistakes increases.
Detailed description
In this project study, it is aimed to determine the effect of simulation and teaching to be developed on the knowledge and skills of nursing students in drug administration. For this purpose, a scenario will be written for subcutaneous, intramuscular and intravenous drug administration skills and a simulation will be developed by simulating it in a virtual environment. After the students who accept to participate in the study, take the pre-test and OSCE exam on the subject, the experimental group students will administer the drugs on the virtual patient. After the students they use simulation, a notification will be sent to the researcher's mail address. Thus, it will be determined how many times the students use simulation. When the three-week probation period is over, students will be taken to the posttest and OSCE exam again. Control group students will only follow the laboratory trainings included in the traditional learning process
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –control |
| experimental | Experimental | Other: simulationexperimental |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Those who have registered for the Fundamentals of Nursing II Course for the first time,
- Having a computer, tablet or smartphone,
- Having internet access,
- Volunteer to participate in the research
Key exclusion criteria (2 listed)
- Having graduated from Health Vocational High School or studied a health-related department,
- Have any previous experience of basic nursing skills
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 |
|---|---|---|
| simulationparenteral drug simulation | Other | experimental |
Primary outcome
Teaching parenteral drug administration through simulation has an effect on the knowledge test average score of nursing students.
Time frame: 3 mounth
Data will be collected through student identification characteristics form, Parenteral Drug Applications Knowledge Test.
1 secondary outcome
Teaching parenteral drug administration through simulation has an effect on the OSCE skill score average of nursing students.
Time frame: 3 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 42267610Biyik Bayram S, Gulnar E, Caliskan N, Ozyurt H, Bayram A. The Effect of Virtual Simulation of Parenteral Medication Administration on Nursing Students' Knowledge and Skills: A Randomized Controlled Experimental Study. Comput Inform Nurs. 2026 Jun 10. doi: 10.1097/CIN.0000000000001581. Online ahead of print.
- 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.
Şule Bıyık Bayram study director
Karadeniz Technical 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 simulation in people with Nursing Education and Cognitive Orientation, run by Karadeniz Technical 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 2 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: status not confirmed, as of the sponsor's last update on 25 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şule BIYIK BAYRAM, phD (+905305053664, sulebiyik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teaching parenteral drug administration through simulation has an effect on the knowledge test average score of nursing students. (time frame: 3 mounth). 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 NCT06195722, which also lists 1 linked publication.
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 25 Jun 2024.