Clinical trial NCT06228716: Education With Hybrid Simulation Method in Patients Administering Subcutaneous Biological Drugs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Administration
Biological Therapy
Training
Keywords: Self administratation
anxiety
subcutaneous injection
biological therapy
simulation training
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research was carried out with a pretest-posttest randomized controlled experimental design to evaluate the effect of the training given by the hybrid simulation method to individuals who self-administer subcutaneous biological drugs on application skills and anxiety levels.
Primary purpose: SUPPORTIVE_CARE

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; 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.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-50,
* Residing in Istanbul,
* Their family/relatives are not using medication in subcutaneous injection form,
* Receiving injection training for the first time,
* First time injection application,
* Using biological medication for the first time,
* Using subcutaneous biological medication for the first time,
* The requested subcutaneous biological drug must be in pen form,
* The drug administration dose should be once every 2 weeks (1/14),
* Being open to communication and cooperation,
* No experience of injecting any living creature (human or animal),
* There is no cognitive, perceptual, or physical disability that would hinder the ability to administer self-injection,
* Volunteering to participate in the research.

Exclusion Criteria:

* Leaving the study at any stage of the research process,
* Not participating in the training and evaluations included in the research,
* Having any local or systemic infectious disease at any stage of the research process.

Primary outcomes:
measure: Patient Information Form
timeFrame: Before training
measure: Determination of state anxiety level/pretest application
timeFrame: Before training and 2. week before first self administration of subcutaneous injection by the patient
measure: Subcutaneous Biological Drug Self-Administration Skill Checklist
timeFrame: 1. week post training; 2. week post training
Secondary outcomes:
measure: Subcutaneous Biological Drug Knowledge Test
timeFrame: 1. week post training
measure: Patient Education Evaluation Survey
timeFrame: 1. week post training
measure: Trait anxiety scale
timeFrame: 1. week post training
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: University of Health Sciences
state: İ̇stanbul
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: İlayda Türkoğlu
role: STUDY_CHAIR
References:
citation: Stenger F, Konig A, Ochsendorf F, Kaufmann R, Pinter A. Correct performance of subcutaneous injections in plaque psoriasis: comparison of trained and untrained patients with different application systems in routine clinical care. J Dermatolog Treat. 2021 Dec;32(8):898-906. doi: 10.1080/09546634.2020.1720580. Epub 2020 Feb 2.
citation: Timmermann H, Mailander C. Home Self-Administration of Biologics - A German Survey among Omalizumab-Treated Patients with Severe Asthma and their Treating Physicians. Pneumologie. 2020 Feb;74(2):103-111. doi: 10.1055/a-1069-0900. Epub 2020 Jan 9.
citation: Fischer-Cartlidge E, Romanoff S, Thom B, Burrows Walters C. Comparing Self-Injection Teaching Strategies for Patients With Breast Cancer and Their Caregivers: A Pilot Study. Clin J Oncol Nurs. 2016 Oct 1;20(5):515-21. doi: 10.1188/16.CJON.515-521.