Simulation-Based Subcutaneous Injection Training in Midwifery Students
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nursemin Unal, PhD, RN
- Número de teléfono: +905077433629
- Correo electrónico: nurse_unal@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Betül TOSUN, PhD, RN
- Correo electrónico: tosunbetul@gmail.com
Ubicaciones de estudio
-
-
-
Ankara, Turquía (Türkiye), 06230
- Ankara University Faculty of Nursing
-
Contacto:
- Nursemin Unal
- Número de teléfono: 05077433629
- Correo electrónico: nurse_unal@hotmail.com
-
Contacto:
- Betül TOSUN, PhD, RN
- Número de teléfono: +905053652121
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mannequin-Based Practice
Participants assigned to this group will perform subcutaneous injection practice on the abdominal area of a patient-care mannequin.
|
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.
|
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.
|
Participants will practice the standardized steps of subcutaneous injection on an injection training pad placed on their own abdomen.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived Learning
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nursemin Unal, PhD,RN, Ankara University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- Spielberger CD, Gorsuch RL, Lushene RE. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1970.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 228
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .