Education With Hybrid Simulation Method in Patients Administering Subcutaneous Biological Drugs

NCT06228716 | Completed DMC

• 1 other identifier: 10840098-772.02-E.60612
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Administration; Biological Therapy; Training

Keywords

Self administratation; anxiety; subcutaneous injection; biological therapy; simulation training

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Subcutaneous Biological Drug Knowledge Test

  1. week post training

• Patient Education Evaluation Survey

  1. week post training

• Trait anxiety scale

  1. week post training

Study Arms (2)

Experimental

EXPERIMENTAL

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. A medicine pen similar to their own medicine pens (demo pen without medicine), dry cotton, alcohol swab (similar to the ones that come in medicine pen boxes), and a small notepad and pen were left in a clean medicine tray on a clean table. 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 training took approximately 40 minutes.

Device: Training with hybrid simulation method

Kontrol Group

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.

Other: Broshure

Interventions

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.

Experimental

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.

Kontrol Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• İlayda Türkoğlu: lead

Study Sites (1)

University of Health Sciences

Üsküdar, İ̇stanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32009495 BACKGROUND

• 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.

  PMID: 31935761 BACKGROUND

• 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.

  PMID: 27668371 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• İlayda Türkoğlu

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Msc

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: July 2, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)