Training Clinical Trial
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
Verified date | January 2024 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | University of Health Sciences | Üsküdar | I?stanbul |
Lead Sponsor | Collaborator |
---|---|
Ilayda Türkoglu |
Turkey,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Information Form | 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 ". | Before training | |
Primary | Determination of state anxiety level/pretest application | 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. | Before training and 2. week before first self administration of subcutaneous injection by the patient | |
Primary | Subcutaneous Biological Drug Self-Administration Skill Checklist | Checklist consisting of 20 application steps to evaluate the skill level of Subcutaneous Biological Drug Self-Administration | 1. week post training; 2. week post training | |
Secondary | Subcutaneous Biological Drug Knowledge Test | 17-item test assessing the level of knowledge about subcutaneous biological drugs | 1. week post training | |
Secondary | Patient Education Evaluation Survey | 5-point Likert-type survey consisting of 10 items on patients' evaluation of education | 1. week post training | |
Secondary | Trait anxiety scale | 20-item scale assessing an individual's trait anxiety. trait anxiety scale | 1. week post training |
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