Viewing Study NCT06228716



Ignite Creation Date: 2024-05-06 @ 8:01 PM
Last Modification Date: 2025-12-17 @ 4:40 PM
Study NCT ID: NCT06228716
Status: None
Last Update Posted: 2024-01-29 00:00:00
First Post: 2024-01-18 00:00:00

Brief Title: Education With Hybrid Simulation Method in Patients Administering Subcutaneous Biological Drugs
Sponsor: İlayda Türkoğlu
Organization: Saglik Bilimleri Universitesi

Study Overview

Official Title: The Effect of the Training Given by Hybrid Simulation Method on The Skill and Anxiety Level of the Patients Applying Subcutaneous Biological Drugs
Status: None
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A poor self-injection experience can lead to undesirable treatment outcomes. However, increasing morbidity and mortality rates are closely related to non-adherence to treatment. Undesirable results due to non-compliance with treatment lead to more visits to emergency services, prolongation of inpatient treatments and increased surgical interventions, thus increasing the workload and costs of health services. In addition, patients who cannot receive repeated and effective training on subcutaneous injection application cause them to experience anxiety about subcutaneous drug administration on their own, and often come to health units only for subcutaneous injection, due to the limited ability to administer. This situation can both negatively affect the daily life activities and self-efficacy perceptions of the patients and increase the workload and cost in health services.

Hybrid Simulation; It is also defined as "patient-centered simulation". In this method; Simulated/standardized patient method is used together with auxiliary tools. Wearable simulation tools are used in this simulation type. When the literature is examined, it is seen that various training methods for self-administration skills are used in patients followed in the rheumatology outpatient clinic, but their effectiveness is controversial. In addition, no study has been found to evaluate the effectiveness of a hybrid simulation-based training on the improvement of application skills and reduction of anxiety regarding subcutaneous injection of biologic drugs, for which adherence to treatment is vital. The aim of this study is to evaluate the effect of training given by simulation method on patients who administer subcutaneous biologic drugs on their application skills and anxiety level. It is thought that these patients, who are trained with the hybrid simulation method, will decrease their negative experiences of subcutaneous biologic drug administration by repetitive applications and incorrect drug administration due to misunderstandings, their injection administration skills will improve, and their anxiety about injection will decrease.

Purpose and Design of the Research

This study was planned in a pre-test-post-test randomized controlled design in order to evaluate the effect of the training given by the hybrid simulation method to the patients who administered subcutaneous biologic drugs on the application skill and anxiety level.
Detailed Description: A poor self-injection experience can lead to undesirable treatment outcomes However increasing morbidity and mortality rates are closely related to non-adherence to treatment Undesirable results due to non-compliance with treatment lead to more visits to emergency services prolongation of inpatient treatments and increased surgical interventions thus increasing the workload and costs of health services In addition patients who cannot receive repeated and effective training on subcutaneous injection application cause them to experience anxiety about subcutaneous drug administration on their own and often come to health units only for subcutaneous injection due to the limited ability to administer This situation can both negatively affect the daily life activities and self-efficacy perceptions of the patients and increase the workload and cost in health services

Hybrid Simulation It is also defined as patient-centered simulation In this method Simulatedstandardized patient method is used together with auxiliary tools Wearable simulation tools are used in this simulation type When the literature is examined it is seen that various training methods for self-administration skills are used in patients followed in the rheumatology outpatient clinic but their effectiveness is controversial In addition no study has been found to evaluate the effectiveness of a hybrid simulation-based training on the improvement of application skills and reduction of anxiety regarding subcutaneous injection of biologic drugs for which adherence to treatment is vital The aim of this study is to evaluate the effect of training given by simulation method on patients who administer subcutaneous biologic drugs on their application skills and anxiety level It is thought that these patients who are trained with the hybrid simulation method will decrease their negative experiences of subcutaneous biologic drug administration by repetitive applications and incorrect drug administration due to misunderstandings their injection administration skills will improve and their anxiety about injection will decrease

Purpose and Design of the Research

This study was planned in a pre-test-post-test randomized controlled design in order to evaluate the effect of the training given by the hybrid simulation method to the patients who administered subcutaneous biologic drugs on the application skill and anxiety level

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None