Simulation TrainingNCT07793188
Simulation-Based Subcutaneous Injection Training in Midwifery Students
A study testing Mannequin-Based Subcutaneous Injection Training, Peer-Based Subcutaneous Injection Training and Self-Based Subcutaneous Injection Training in people with Simulation Training and Midwifery Education, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare three simulation-based approaches for teaching subcutaneous injections to first-year midwifery students. A subcutaneous injection is an injection given into the tissue just under the skin. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simulation Training, Midwifery Education, Subcutaneous Injection
- What is being tested?
- Mannequin-Based Subcutaneous Injection Training, Peer-Based Subcutaneous Injection Training and Self-Based Subcutaneous Injection Training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students enrolled in the Midwifery Program at Ankara University Faculty of Nursing who took the Fundamentals of Midwifery Practice course for the first time during the 2025-2026 academic year.
- Willing to participate in the study and provide informed consent.
Who cannot join
- Previous experience with self-administered subcutaneous injection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Betül TOSUN, PhD, RN contact
Turkey (Türkiye)1 site
Ankara University Faculty of Nursing
Ankara, 06230
Nursemin Unal, 05077433629, nurse_unal@hotmail.com
Betül TOSUN, PhD, RN, +905053652121
About this study
Official title: Effects of Different Simulation-Based Approaches to Subcutaneous Injection Training on Learning Outcomes, Self-Efficacy, and Anxiety in Midwifery Students
The goal of this clinical trial is to compare three simulation-based approaches for teaching subcutaneous injections to first-year midwifery students. A subcutaneous injection is an injection given into the tissue just under the skin. The main questions this study aims to answer are:
Do the three teaching approaches lead to different levels of learning and injection skills? Do the approaches affect students' confidence in performing the skill? Do the approaches affect students' anxiety during injection practice?
Read more
Researchers will compare three groups of midwifery students. One group will practice on the abdominal area of a patient-care mannequin. A second group will practice on an injection training pad placed on a peer's abdomen. A third group will practice on an injection training pad placed on their own abdomen.
Participants will first receive the same classroom teaching and laboratory instruction on subcutaneous injection. One week later, they will practice the injection according to the group to which they were randomly assigned. No medication will be injected into a participant's body; the practice will use training equipment and saline solution. After the practice, researchers will assess participants' learning, injection skills, self-efficacy, and anxiety.
Read the detailed description
This randomized controlled study evaluates three simulation-based approaches to teaching subcutaneous injection skills to first-year midwifery students. All students will receive the same theoretical instruction and laboratory-based teaching on subcutaneous heparin injection. During the laboratory session, students will practice the standardized steps of the procedure using the Subcutaneous Heparin Injection Practice Guide. One week later, participants will repeat the procedure according to their randomly assigned training approach.
The three approaches differ in the level of physical realism and personal involvement during practice. Students will perform the procedure either on the abdominal area of a patient-care mannequin, on an injection training pad placed on a peer's abdomen, or on an injection training pad placed on their own abdomen. For safety, the simulation will use an insulin syringe containing saline instead of a prefilled heparin syringe. The study is designed to determine whether these different practice contexts provide different educational experiences during subcutaneous injection training and to inform future clinical skills teaching strategies in midwifery education.
- Being tested
- Mannequin-Based Subcutaneous Injection Training, Peer-Based Subcutaneous Injection Training, Self-Based Subcutaneous Injection Training
- Keywords
- Simulation-Based Education, Subcutaneous Injection, Midwifery Students, Clinical Skills Training, Self-Efficacy, Anxiety, Perceived Learning
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannequin-Based Subcutaneous Injection TrainingOther
Participants will practice the standardized steps of subcutaneous injection on the abdominal area of a patient-care mannequin.
Peer-Based Subcutaneous Injection TrainingOther
The injection will be administered into the training pad and will not penetrate the peer's body.
Self-Based Subcutaneous Injection TrainingOther
Participants will practice the standardized steps of subcutaneous injection on an injection training pad placed on their own abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Mannequin-Based Practice | Experimental | Participants assigned to this group will perform subcutaneous injection practice on the abdominal area of a patient-care mannequin. Receives: Other: Mannequin-Based Subcutaneous Injection Training |
| Peer-Based Practice | Experimental | Participants assigned to this group will perform subcutaneous injection practice on an injection training pad placed on a peer's abdomen. Receives: Other: Peer-Based Subcutaneous Injection Training |
| Self-Based Practice | Experimental | Participants assigned to this group will perform subcutaneous injection practice on an injection training pad placed on their own abdomen. Receives: Other: Self-Based Subcutaneous Injection Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Learning
Perceived learning will be assessed using the Perceived Learning Scale. The scale consists of 9 items covering cognitive, affective, and psychomotor learning. Total scores range from 9 to 63, with higher scores indicating greater perceived learning.
Measured: Immediately after the simulation-based practice session
Self-Efficacy for Subcutaneous Injection
Self-efficacy will be assessed using the Subcutaneous Heparin Injection Self-Efficacy Form. Participants rate how competent they feel in performing the skill safely and correctly on a scale from 1 to 10, with higher scores indicating greater self-efficacy.
Measured: Immediately after the simulation-based practice session
State Anxiety
State anxiety will be assessed using the State Anxiety Inventory. The scale consists of 20 items and yields a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
Measured: Immediately after the simulation-based practice session
Subcutaneous Injection Skill Performance
Subcutaneous injection skill performance will be assessed using the Subcutaneous Heparin Injection Practice Skills Checklist developed by the researchers based on current literature and expert review. The checklist evaluates whether the required steps of the procedure are performed correctly. Higher total scores indicate better subcutaneous injection skill performance.
Measured: During the simulation-based practice session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start7 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel simulation-based training groups: subcutaneous injection practice on a patient-care mannequin, on an injection training pad placed on a peer's abdomen, or on an injection training pad placed on the participant's own abdomen.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursemin ÜNAL, Ankara University
- Investigators
- Nursemin Unal, PhD,RN, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793188
- Sponsor's protocol ID
- 228
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because no data-sharing plan was included in the study protocol or informed consent process.
Publications
Spielberger CD, Gorsuch RL, Lushene RE. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1970.
Chen SH, Lin BB, Wang XY, Xu GR, Song JH. Construction and implementation of a comprehensive midwifery skills practice course based on scenario simulation teaching: An action research. Nurse Educ Today. 2025 Sep;152:106754. doi: 10.1016/j.nedt.2025.106754. Epub 2025 Apr 17.
PubMed 40288241Cant RP, Cooper SJ. Use of simulation-based learning in undergraduate nurse education: An umbrella systematic review. Nurse Educ Today. 2017 Feb;49:63-71. doi: 10.1016/j.nedt.2016.11.015. Epub 2016 Nov 22.
PubMed 27902949Shin S, Park JH, Kim JH. Effectiveness of patient simulation in nursing education: meta-analysis. Nurse Educ Today. 2015 Jan;35(1):176-82. doi: 10.1016/j.nedt.2014.09.009. Epub 2014 Oct 29.
PubMed 25459172Kokkiz R, Inangil D, Turkoglu I. The effect of formative assessment on students' clinical knowledge, skills and self-efficacy levels. Nurse Educ Pract. 2024 Oct;80:104120. doi: 10.1016/j.nepr.2024.104120. Epub 2024 Aug 28.
PubMed 39213838
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Simulation-Based Approaches to Subcutaneous Injection Training on Learning Outcomes, Self-Efficacy, and Anxiety in Midwifery Students
- ClinicalTrials.gov ID
- NCT07793188
- Acronym / sponsor ID
- 228
- Keywords
- Simulation-Based Education, Subcutaneous Injection, Midwifery Students, Clinical Skills Training, Self-Efficacy, Anxiety, Perceived Learning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Aug 2026 (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.
The goal of this clinical trial is to compare three simulation-based approaches for teaching subcutaneous injections to first-year midwifery students. A subcutaneous injection is an injection given into the tissue just under the skin. The main questions this study aims to answer are:
Do the three teaching approaches lead to different levels of learning and injection skills? Do the approaches affect students' confidence in performing the skill? Do the approaches affect students' anxiety during injection practice?
Researchers will compare three groups of midwifery students. One group will practice on the abdominal area of a patient-care mannequin. A second group will practice on an injection training pad placed on a peer's abdomen. A third group will practice on an injection training pad placed on their own abdomen.
Participants will first receive the same classroom teaching and laboratory instruction on subcutaneous injection. One week later, they will practice the injection according to the group to which they were randomly assigned. No medication will be injected into a participant's body; the practice will use training equipment and saline solution. After the practice, researchers will assess participants' learning, injection skills, self-efficacy, and anxiety.
Detailed description
This randomized controlled study evaluates three simulation-based approaches to teaching subcutaneous injection skills to first-year midwifery students. All students will receive the same theoretical instruction and laboratory-based teaching on subcutaneous heparin injection. During the laboratory session, students will practice the standardized steps of the procedure using the Subcutaneous Heparin Injection Practice Guide. One week later, participants will repeat the procedure according to their randomly assigned training approach.
The three approaches differ in the level of physical realism and personal involvement during practice. Students will perform the procedure either on the abdominal area of a patient-care mannequin, on an injection training pad placed on a peer's abdomen, or on an injection training pad placed on their own abdomen. For safety, the simulation will use an insulin syringe containing saline instead of a prefilled heparin syringe. The study is designed to determine whether these different practice contexts provide different educational experiences during subcutaneous injection training and to inform future clinical skills teaching strategies in midwifery education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel simulation-based training groups: subcutaneous injection practice on a patient-care mannequin, on an injection training pad placed on a peer's abdomen, or on an injection training pad placed on the participant's own abdomen.
| Arm | Type | Receives |
|---|---|---|
| Mannequin-Based Practice | Experimental | Other: Mannequin-Based Subcutaneous Injection TrainingParticipants assigned to this group will perform subcutaneous injection practice on the abdominal area of a patient-care mannequin. |
| Peer-Based Practice | Experimental | Other: Peer-Based Subcutaneous Injection TrainingParticipants assigned to this group will perform subcutaneous injection practice on an injection training pad placed on a peer's abdomen. |
| Self-Based Practice | Experimental | Other: Self-Based Subcutaneous Injection TrainingParticipants assigned to this group will perform subcutaneous injection practice on an injection training pad placed on their own abdomen. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Students enrolled in the Midwifery Program at Ankara University Faculty of Nursing who took the Fundamentals of Midwifery Practice course for the first time during the 2025-2026 academic year.
- Willing to participate in the study and provide informed consent.
Key exclusion criteria (1 listed)
- Previous experience with self-administered subcutaneous injection
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 |
|---|---|---|
| Mannequin-Based Subcutaneous Injection TrainingParticipants will practice the standardized steps of subcutaneous injection on the abdominal area of a patient-care mannequin. | Other | Mannequin-Based Practice |
| Peer-Based Subcutaneous Injection TrainingThe injection will be administered into the training pad and will not penetrate the peer's body. | Other | Peer-Based Practice |
| Self-Based Subcutaneous Injection TrainingParticipants will practice the standardized steps of subcutaneous injection on an injection training pad placed on their own abdomen. | Other | Self-Based Practice |
Primary outcome
Perceived Learning
Time frame: Immediately after the simulation-based practice session
Perceived learning will be assessed using the Perceived Learning Scale. The scale consists of 9 items covering cognitive, affective, and psychomotor learning. Total scores range from 9 to 63, with higher scores indicating greater perceived learning.
Self-Efficacy for Subcutaneous Injection
Time frame: Immediately after the simulation-based practice session
Self-efficacy will be assessed using the Subcutaneous Heparin Injection Self-Efficacy Form. Participants rate how competent they feel in performing the skill safely and correctly on a scale from 1 to 10, with higher scores indicating greater self-efficacy.
State Anxiety
Time frame: Immediately after the simulation-based practice session
State anxiety will be assessed using the State Anxiety Inventory. The scale consists of 20 items and yields a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
Subcutaneous Injection Skill Performance
Time frame: During the simulation-based practice session
Subcutaneous injection skill performance will be assessed using the Subcutaneous Heparin Injection Practice Skills Checklist developed by the researchers based on current literature and expert review. The checklist evaluates whether the required steps of the procedure are performed correctly. Higher total scores indicate better subcutaneous injection skill performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- BackgroundSpielberger CD, Gorsuch RL, Lushene RE. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1970.
- Background: PubMed 40288241Chen SH, Lin BB, Wang XY, Xu GR, Song JH. Construction and implementation of a comprehensive midwifery skills practice course based on scenario simulation teaching: An action research. Nurse Educ Today. 2025 Sep;152:106754. doi: 10.1016/j.nedt.2025.106754. Epub 2025 Apr 17.
- Background: PubMed 27902949Cant RP, Cooper SJ. Use of simulation-based learning in undergraduate nurse education: An umbrella systematic review. Nurse Educ Today. 2017 Feb;49:63-71. doi: 10.1016/j.nedt.2016.11.015. Epub 2016 Nov 22.
- Background: PubMed 25459172Shin S, Park JH, Kim JH. Effectiveness of patient simulation in nursing education: meta-analysis. Nurse Educ Today. 2015 Jan;35(1):176-82. doi: 10.1016/j.nedt.2014.09.009. Epub 2014 Oct 29.
- Background: PubMed 39213838Kokkiz R, Inangil D, Turkoglu I. The effect of formative assessment on students' clinical knowledge, skills and self-efficacy levels. Nurse Educ Pract. 2024 Oct;80:104120. doi: 10.1016/j.nepr.2024.104120. Epub 2024 Aug 28.
- Individual participant dataSharing planned: No. IPD will not be shared because no data-sharing plan was included in the study protocol or informed consent process.
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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.
Betül TOSUN, PhD, RN contact
Nursemin Unal, PhD,RN principal investigator
Ankara 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 Mannequin-Based Subcutaneous Injection Training, Peer-Based Subcutaneous Injection Training and Self-Based Subcutaneous Injection Training in people with Simulation Training and Midwifery Education, run by Ankara 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nursemin Unal, PhD, RN (+905077433629, nurse_unal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Learning (time frame: Immediately after the simulation-based practice session). The study lists 4 primary outcomes in all. 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 NCT07793188, which also lists 5 linked publications.
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 28 Aug 2026.