Simulation-Based Subcutaneous Injection Training in Midwifery Students

August 26, 2026 updated by: Nursemin ÜNAL, Ankara University

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?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

78

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Ankara University Faculty of Nursing
        • Contact:
        • Contact:
          • Betül TOSUN, PhD, RN
          • Phone Number: +905053652121

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participants will practice the standardized steps of subcutaneous injection on the abdominal area of a patient-care mannequin.
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
The injection will be administered into the training pad and will not penetrate the peer's body.
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
Participants will practice the standardized steps of subcutaneous injection on an injection training pad placed on their own abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the simulation-based practice session
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.
Immediately after the simulation-based practice session
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.
Immediately after the simulation-based practice session
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.
During the simulation-based practice session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Nursemin Unal, PhD,RN, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 7, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

August 26, 2026

First Submitted That Met QC Criteria

August 26, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because no data-sharing plan was included in the study protocol or informed consent process.

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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