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NCT Number: NCT07793188

Simulation-Based Subcutaneous Injection Training 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?

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.

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Key information

Conditions

Simulation Training Anxiety Disorders Mental Disorders Midwifery Education Subcutaneous Injection

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent.

Exclusion criteria

  • Previous experience with self-administered subcutaneous injection

Treatment and study plan

Mannequin-Based Subcutaneous Injection Training

Other

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

Peer-Based Subcutaneous Injection Training

Other

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

Self-Based Subcutaneous Injection Training

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Betül TOSUN, PhD, RN

CONTACT

[email protected]

Nursemin Unal, PhD, RN

CONTACT

[email protected]

+905077433629

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Effects of Different Simulation-Based Approaches to Subcutaneous Injection Training on Learning Outcomes, Self-Efficacy, and Anxiety in Midwifery Students

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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