- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07674108
VR Simulation-Based Implanted Port Catheter Training in Nursing Students
25 de junio de 2026 actualizado por: Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University
Effectiveness of Virtual Reality Simulation-Based Implanted Port Catheter Training on Knowledge, Learning Satisfaction and Motivation in Nursing Students: A Randomized Controlled Trial
Implanted port catheter care is a critical clinical skill in oncology nursing, requiring accurate knowledge, aseptic technique, safe procedural practice, and early recognition of potential complications.
This parallel group randomized controlled study aims to evaluate the effectiveness of virtual reality simulation-based implanted port catheter training in undergraduate nursing students.
Eligible second-year nursing students will be randomly assigned to either an intervention group or a control group.
All students will receive a two-hour traditional implanted port catheter training session in the classroom setting.
In addition to traditional training, students in the intervention group will receive virtual reality simulation-based training consisting of two scenarios: safe implanted port catheter access and extravasation/complication management.
The control group will receive only traditional training.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Pinar Zorba Bahceli, PhD
- Número de teléfono: +90 553 487 25 50
- Correo electrónico: pinarzorba85@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Hasan Onur Duman, RN
- Número de teléfono: +90 534 449 88 83
- Correo electrónico: 6010036@bakircay.edu.tr
Ubicaciones de estudio
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Izmir, Turquía (Türkiye)
- Izmir Bakircay University
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Contacto:
- Pinar Zorba Bahceli, PhD
- Número de teléfono: +90 553 487 25 50
- Correo electrónico: pinarzorba85@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Being 18 years of age or older
- Being an undergraduate nursing student
- Having completed the Internal Medicine Nursing course
- Voluntarily agreeing to participate in the study
- Providing written informed consent
Exclusion Criteria:
- Having any communication barrier that may prevent participation in the study or completion of the study forms
- Having neck pain or neck injury severe enough to prevent head movement
- Having a visual problem that prevents safe use of the virtual reality application
- Experiencing severe nausea or dizziness during the virtual reality application
- Having a diagnosed history of epilepsy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Virtual Reality Simulation-Based Implanted Port Catheter Training Group
Nursing students in this group will receive a two-hour traditional implanted port catheter training session in the classroom setting.
In addition to traditional training, they will receive virtual reality simulation-based implanted port catheter training consisting of two structured scenarios: safe implanted port catheter access and extravasation/complication management.
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The virtual reality simulation-based implanted port catheter training will be provided in addition to traditional classroom-based training.
The VR training will be delivered individually using a Meta Quest 3 headset and will consist of two structured scenarios.
The first scenario will focus on safe implanted port catheter access, line verification, flushing, dressing, and documentation.
The second scenario will focus on recognition and management of suspected extravasation or related complications during an ongoing infusion.
Each scenario is expected to last approximately 10 minutes, with a total VR training duration of approximately 20 minutes.
The VR system will provide an interactive, standardized, and repeatable learning environment and will generate performance indicators related to students' procedural steps, critical errors, and complication management decisions.
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Sin intervención: Control Group
Nursing students in this group will receive only a two-hour traditional implanted port catheter training session in the classroom setting.
They will not receive virtual reality simulation-based training.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Implanted Port Catheter Knowledge Assessment Checklist Score
Periodo de tiempo: Baseline, pre-intervention; immediately after the intervention
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The primary outcome is the change in students' implanted port catheter knowledge score from baseline to immediately after training.
Knowledge will be assessed using the Structured Implanted Port Catheter Knowledge Assessment Checklist.
The outcome will be evaluated by comparing the change in knowledge score from baseline to after training between the intervention and control groups.
Higher scores indicate a higher level of knowledge regarding implanted port catheter care and application.
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Baseline, pre-intervention; immediately after the intervention
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Change in Student Satisfaction and Self-Confidence in Learning Scale Score
Periodo de tiempo: Baseline, pre-intervention; immediately after the intervention
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Students' satisfaction and self-confidence related to the learning experience will be assessed after the intervention using the Student Satisfaction and Self-Confidence in Learning Scale.
The satisfaction-related score will be compared between the intervention and control groups.
Higher scores indicate higher levels of satisfaction and self-confidence in learning.
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Baseline, pre-intervention; immediately after the intervention
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Change in Instructional Materials Motivation Survey Score
Periodo de tiempo: Baseline, pre-intervention; immediately after the intervention
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Nursing students' motivation toward the instructional material will be assessed baseline and after training using the Instructional Materials Motivation Scale.
Motivation scores will be compared between the intervention and control groups.
Higher scores indicate higher motivation toward the instructional material.
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Baseline, pre-intervention; immediately after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Implanted Port Catheter Application Performance Score
Periodo de tiempo: During the virtual reality simulation session, immediately after completion of each VR scenario
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The implanted port catheter application performance score will be assessed only in the intervention group during the virtual reality simulation session.
This score will be generated by the virtual reality system and will include performance indicators related to routine implanted port catheter application and extravasation/complication management.
The score will reflect students' completion of procedural steps, critical safety actions, errors, and complication management decisions during the VR scenarios.
This outcome will be analyzed as an intervention-group-specific secondary process outcome and will not be used for between-group effectiveness comparison because the control group will not be exposed to the virtual reality simulation environment.
Higher scores indicate better implanted port catheter application performance in the VR simulation environment.
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During the virtual reality simulation session, immediately after completion of each VR scenario
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
21 de septiembre de 2026
Finalización primaria (Estimado)
4 de enero de 2027
Finalización del estudio (Estimado)
28 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
21 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
29 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026/2823
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .