- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06195722
Developing a Simulation for Parenteral Drug Administration
December 22, 2023 updated by: Sule BIYIK BAYRAM, Karadeniz Technical University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Şule BIYIK BAYRAM, phD
- Phone Number: +905305053664
- Email: sulebiyik@gmail.com
Study Locations
-
-
Ortahisar
-
Trabzon, Ortahisar, Turkey, 61080
- Sule Biyik Bayram
-
Contact:
- Emel GÜLNAR, phd
- Phone Number: +903183573738
- Email: emelglnr@gmail.com
-
Sub-Investigator:
- Nurcan ÇALIŞKAN, Phd
-
Sub-Investigator:
- Hacer ÖZYURT, Phd
-
Sub-Investigator:
- Emel GÜLNAR, Phd
-
Sub-Investigator:
- Aysun BAYRAM, Msc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having graduated from Health Vocational High School or studied a health-related department,
- Have any previous experience of basic nursing skills
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
|
|
Experimental: experimental
|
parenteral drug simulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 mounth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Teaching parenteral drug administration through simulation has an effect on the OSCE skill score average of nursing students.
Time Frame: 3 mounth
|
Data will be collected through Drug Applications Skill Checklists
|
3 mounth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Şule Bıyık Bayram, Karadeniz Technical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
June 10, 2024
Study Completion (Estimated)
March 30, 2025
Study Registration Dates
First Submitted
December 12, 2023
First Submitted That Met QC Criteria
December 22, 2023
First Posted (Estimated)
January 8, 2024
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
December 22, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- KaradenizTU-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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