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Not yet recruitingNCT07793188Updated Aug 28, 2026

Simulation-Based Subcutaneous Injection Training in Midwifery Students

An interventional study of Mannequin-Based Subcutaneous Injection Training and Peer-Based Subcutaneous Injection Training in Simulation Training, Midwifery Education and Subcutaneous Injection, sponsored by Ankara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Ankara University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Sex
Female
01

Study 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. 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.

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.

02

Conditions studied

  • Simulation Training
  • Midwifery Education
  • Subcutaneous Injection

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Keywords

  • Simulation-Based Education
  • Subcutaneous Injection
  • Midwifery Students
  • Clinical Skills Training
  • Self-Efficacy
  • Anxiety
  • Perceived Learning
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 78 is close to the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Ankara University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • Previous experience with self-administered subcutaneous injection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Mannequin-Based Practice

    Participants assigned to this group will perform subcutaneous injection practice on the abdominal area of a patient-care mannequin.

    Other: Mannequin-Based Subcutaneous Injection Training

  • Experimental
    Peer-Based Practice

    Participants assigned to this group will perform subcutaneous injection practice on an injection training pad placed on a peer's abdomen.

    Other: Peer-Based Subcutaneous Injection Training

  • Experimental
    Self-Based Practice

    Participants assigned to this group will perform subcutaneous injection practice on an injection training pad placed on their own abdomen.

    Other: Self-Based Subcutaneous Injection Training

Interventions

  • OtherMannequin-Based Subcutaneous Injection Training

    Participants will practice the standardized steps of subcutaneous injection on the abdominal area of a patient-care mannequin.

  • OtherPeer-Based Subcutaneous Injection Training

    The injection will be administered into the training pad and will not penetrate the peer's body.

  • OtherSelf-Based Subcutaneous Injection Training

    Participants will practice the standardized steps of subcutaneous injection on an injection training pad placed on their own abdomen.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after the simulation-based practice session

  2. 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.

    Time frame: Immediately after the simulation-based practice session

  3. 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.

    Time frame: Immediately after the simulation-based practice session

  4. 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.

    Time frame: During the simulation-based practice session

07

Study locations

1 site
08

References and documents

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 40288241 ↗
  • Cant 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 27902949 ↗
  • Shin 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 25459172 ↗
  • Kokkiz 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 ↗

Individual participant data

Plan to share: No — IPD will not be shared because no data-sharing plan was included in the study protocol or informed consent process.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07793188
Lead sponsor
Ankara University
Responsible party
Nursemin ÜNAL (Associate Professor, Ankara University) — Principal investigator
First posted
Aug 28, 2026
Start date
Sep 7, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Aug 28, 2026

Study contacts

Nursemin Unal, PhD, RN
Contact
nurse_unal@hotmail.com
+905077433629
Betül TOSUN, PhD, RN
Contact
tosunbetul@gmail.com
Nursemin Unal, PhD,RN
principal investigator · Ankara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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