InjectionsNCT06761456
Parenteral Injection Training Module
A study testing Providing training models in people with Injections and Simulation Training, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injections, Simulation Training
- What is being tested?
- Providing training models
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Injections, Simulation Training
- Being tested
- Providing training models, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing training modelsOther
The experimental group was trained using the Clinical Education Module on 3 Parenteral Interventions in the Nursing Fundamentals laboratory.
ControlOther
The control group was trained using standard training models.
| Study group | Role | What they receive |
|---|---|---|
| Working with a training model | Experimental | 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. Receives: Other: Providing training models |
| Working without a training model | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students' self-efficacy scores for applications will increase
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.
Measured: 3 weeks
The student's satisfaction with the education provided and the self-confidence scale scores in learning will increase.
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start15 Dec 2024
- Primary completion25 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjectionsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Kokkiz, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761456
- Sponsor's protocol ID
- 17.12.2024-34249
- Status last verified
- Jun 2026
- First submitted
- 29 Dec 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Parenteral Injection Training Module and Investigation of Its Effectiveness
- ClinicalTrials.gov ID
- NCT06761456
- Acronym / sponsor ID
- 17.12.2024-34249
- Conditions
- Injections, Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 7 Jan 2025 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working with a training model | Experimental | Other: Providing training modelsAfter 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. |
| Working without a training model | Active comparator | Other: ControlAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Providing training modelsThe experimental group was trained using the Clinical Education Module on 3 Parenteral Interventions in the Nursing Fundamentals laboratory. | Other | Working with a training model |
| ControlThe control group was trained using standard training models. | Other | Working without a training model |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing training models in people with Injections and Simulation Training, run by Fenerbahce 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: finished, as of the sponsor's last update on 22 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Students' self-efficacy scores for applications will increase (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.