The Effect of the Training Given by Hybrid Simulation Method on The Skill and Anxiety Level of the Patients Applying Subcutaneous Biological Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Patient Information Form
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The individual and the independent observer participating in the subcutaneous biological drug administration skill evaluation were enabled to participate in the evaluation process with a blinding method.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient Information Form
时间窗: Before training
It was structured by the researcher in line with the literature and included demographic information such as "the individual's name, surname, age, gender, marital status, education level" as well as "medical diagnosis, the name of the subcutaneous medication used and whether he/she has received any simulation-based training before and his phone number." It consisted of 11 questions including ".
Determination of state anxiety level/pretest application
时间窗: Before training and 2. week before first self administration of subcutaneous injection by the patient
All individuals in both the experimental and control groups included in the sample were asked to fill out the State Anxiety Scale to evaluate their anxiety levels before the subcutaneous biological drug administration training.
Subcutaneous Biological Drug Self-Administration Skill Checklist
时间窗: 1. week post training; 2. week post training
Checklist consisting of 20 application steps to evaluate the skill level of Subcutaneous Biological Drug Self-Administration
次要结局
- Subcutaneous Biological Drug Knowledge Test(1. week post training)
- Patient Education Evaluation Survey(1. week post training)
- Trait anxiety scale(1. week post training)
研究者
İlayda Türkoğlu
Msc
Saglik Bilimleri Universitesi