Developing a Simulation for Parenteral Drug Administration

June 22, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Ortahisar
      • Trabzon, Ortahisar, Turkey, 61080
        • Şule BIYIK BAYRAM
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
Experimental: experimental
Other: simulation
parenteral drug simulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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