Parenteral Injection Training Module

June 18, 2026 updated by: Rukiye Kokkiz, Fenerbahce University

Development of a Parenteral Injection Training Module and Investigation of Its Effectiveness

Injection practices are a legal obligation of healthcare professionals, but they are also ethically responsible, and the safe maintenance of these practices is extremely important for both patient and employee safety. Due to reasons such as the lack of knowledge and skills of healthcare professionals regarding safe injection, lack of experience, in-service training and periodic training for newly recruited personnel, situations that threaten patient and employee safety occur. Mistakes made in situations requiring technical skills related to injection practices lead to local complications such as ecchymosis, hematoma, pain, abscess, lipodystrophy, infection, and can result in life-threatening situations. In addition, lack of technical skills causes sharp-edge injuries in the world and in excess of their number, and causes blood-borne diseases for many healthcare professionals. In order to prevent these complications and injuries, the education of healthcare professionals requires an education system based on theory and clinical practice, supporting students' cognitive, sensory and psychomotor skills. In the education process, the aim should be to provide clinical skills as well as theoretical knowledge and to develop the acquired skills. Because clinical education allows students to integrate theoretical knowledge with practice in healthcare settings and learn by experience. Gaining competence in parenteral interventions in the clinic is a gradual process and is one of the most important issues in both undergraduate education and postgraduate in-service training. Although clinical practice training is one of the basic practices for learning and acquiring clinical skills in traditional medical and nursing education curricula, it is seen that it is insufficient and it is recommended to benefit from developments in the field of educational technologies in order for practice training to increase patient and student safety. Considering the increasing emphasis on the right of patients to receive care from well-educated health professionals and the right of employees to be safe in risky practices, it is thought that developing a tool that will provide students with the opportunity to practice repeatedly in parenteral injection practice training will be an effective tool in solving all the problems mentioned above. For this purpose, the parenteral practice (intravenous, intramuscular, subcutaneous) skill training module, which is targeted to be developed in the project, aims to improve students' injection skills, provide safe injection practices and ensure their own safety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
65

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 Locations

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Students who were 18 years of age or older,
  • Enrolled in the Fundamentals of Nursing course,
  • Fully participated in the assessments to be applied in the study,
  • Volunteered to participate in the study were included in the study

Exclusion Criteria:

  • Students who filled in the forms applied within the scope of the study with incomplete information
  • Students who dropped out of the Fundamentals of Nursing course while the study was ongoing

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: Health Services Research
  • 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.
Experimental: Working with a training model
After the theoretical and skill practice demonstration on parenteral injection application and the application of the pre-test forms, the students were asked to apply parenteral injections using the Clinical Education Module in which 3 Parenteral Interventions could be Applied in the Nursing Fundamentals Laboratory.
Other: Providing training models
The experimental group was trained using the Clinical Education Module on 3 Parenteral Interventions in the Nursing Fundamentals laboratory.
Active Comparator: Working without a training model
After the theoretical and skill practice demonstration on parenteral injection administration and the application of the pre-test forms, the students were asked to apply parenteral injections using a simple model in the Fundamentals of Nursing Laboratory.
Other: Control
The control group was trained using standard training models.

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
Students' self-efficacy scores for applications will increase
Time Frame: 3 weeks
It is a questionnaire form developed by researchers similar to the Visual Analog Scale (VAS) developed by Hayes and Patterson in 1921, which requires students to evaluate their self-efficacy according to their application skills, with 1 point being the lowest and 10 points being the highest.
3 weeks
The student's satisfaction with the education provided and the self-confidence scale scores in learning will increase.
Time Frame: 3 weeks
It was developed by Jeffries and Rizzolo (2006) and its Turkish validity and reliability were made by Ünver et al. in 2017 (14). It consists of the subheadings "Satisfaction with Current Learning" and "Self-confidence in Learning". The subheadings of freedom with current learning consist of 5 items, the subheading of diseases in learning consists of 7 items and there are no negative items. It is evaluated that the student's self-confidence in learning has increased. The internal pressure density in temperature is 0.83. Permission to use the scale has been obtained from the author.
3 weeks

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.
Fenerbahce 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 (Actual)

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.
December 15, 2024

Primary Completion (Actual)

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.
December 25, 2024

Study Completion (Actual)

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.
January 15, 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 29, 2024

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.
January 5, 2025

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 7, 2025

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 22, 2026

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 18, 2026

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, 2026

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.
  • 17.12.2024-34249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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