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Completed

NCT Number: NCT06228716

Education With Hybrid Simulation Method in Patients Administering Subcutaneous Biological Drugs

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences

Üsküdar, İ̇stanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training with hybrid simulation method

Device

Subcutaneous biological drug self-administration training was given by the researcher in two stages, theoretical and practical, face to face. Power point presentation and training brochure were used in theoretical training. The practical training given after the theoretical training was given using the Hybrid simulation method. The Wearable Subcutaneous Injection Hybrid Simulator developed by the researcher was worn by the individuals after being informed about its purpose and function. Afterwards, they were expected to apply the subcutaneous application step by step as explained to them. Each application step they made incorrectly was corrected and repeated with the support of the researcher. The application was considered successful if they completed all application steps correctly from start to finish. The training took approximately 40 minutes. After the practical training, the individuals' questions, if any, were answered and the training was terminated.

Broshure

Other

Subcutaneous biological drug self-administration training was given theoretically face to face by the researcher using a power point presentation and training brochure. The training lasted approximately 25 minutes and was given in the same room where the experimental group received training. After the training, any questions the individuals had were answered and the training was ended.

Primary outcomes

  1. Patient Information Form

    Time frame: 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 ".

  2. Determination of state anxiety level/pretest application

    Time frame: 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.

  3. Subcutaneous Biological Drug Self-Administration Skill Checklist

    Time frame: 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

Secondary outcomes

  1. Subcutaneous Biological Drug Knowledge Test

    Time frame: 1. week post training

    17-item test assessing the level of knowledge about subcutaneous biological drugs

  2. Patient Education Evaluation Survey

    Time frame: 1. week post training

    5-point Likert-type survey consisting of 10 items on patients' evaluation of education

  3. Trait anxiety scale

    Time frame: 1. week post training

    20-item scale assessing an individual's trait anxiety. trait anxiety scale

Sponsors and collaborators

Lead sponsor

İlayda Türkoğlu

Other

Registry information

Official study title

The Effect of the Training Given by Hybrid Simulation Method on The Skill and Anxiety Level of the Patients Applying Subcutaneous Biological Drugs

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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