Simulation-Based Subcutaneous Injection Training in Midwifery Students

NCT07793188 | Not Yet Recruiting

• 1 other identifier: 228
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Simulation Training; Midwifery Education; Subcutaneous Injection

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  During the simulation-based practice session

Study Arms (3)

Mannequin-Based Practice

EXPERIMENTAL

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

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.

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.

Other: Self-Based Subcutaneous Injection Training

Interventions

Mannequin-Based Subcutaneous Injection Training OTHER

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

Mannequin-Based Practice

Peer-Based Subcutaneous Injection Training OTHER

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

Peer-Based Practice

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.

Self-Based Practice

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous experience with self-administered subcutaneous injection

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Nursing

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (5)

• Spielberger CD, Gorsuch RL, Lushene RE. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1970.

  BACKGROUND

• 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.

  PMID: 40288241 BACKGROUND

• 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.

  PMID: 27902949 BACKGROUND

• 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.

  PMID: 25459172 BACKGROUND

• 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.

  PMID: 39213838 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nursemin Unal, PhD,RN

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nursemin Unal, PhD, RN

CONTACT

+905077433629; nurse_unal@hotmail.com

Betül TOSUN, PhD, RN

CONTACT

tosunbetul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)