Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06228716
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2024-01-18
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:
COMPLETED
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:
In recent years vital drugs such as heparin insulin growth hormone interferons monoclonal antibodies and drugs containing proteins that can be destroyed in the gastrointestinal tract have been developed in the form of self-subcutaneous injection in order to reduce the negative effects of treatment practices on the lives of patients After the training the patients can apply the subcutaneous injection on their own without assistance This situation reduces the dependency on the nurse and allows the patient to apply the injection on time without the need to reach the health institutions In a study it is stated that the inadequacy of injection training causes many patients to develop inappropriate injection behavior patterns and to acquire habits regarding these inappropriate techniques It is also stated that the anxiety they experienced before the injection caused them to ignore the critical steps towards the injection application In this study the Subcutaneous Injection Hybrid Model developed by the researcher will be used in the training of patients who administer biologic drugs subcutaneously It is thought that these patients will improve their injection practice skills and reduce their anxiety about injection by repetitive applications by training with the hybrid simulation method
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
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