Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills (EETDTMSSİS)

Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills in Type 2 Diabetes Mellitus Patients

Subject: Subcutaneous (SC) insulin injection is frequently used in the treatment of Type 2 Diabetes patients. Complications such as pain, ecchymosis, hematoma, lipoatrophy and lipohypertrophy are frequently observed after SC injections. These complications that develop due to incorrect injection application negatively affect the use of injection application areas, change body image and negatively affect drug absorption. In order to reduce and prevent complications related to SC insulin injection, it is very important to gain the skill of safe SC insulin injection. It is stated that there are a limited number of studies on which of the teaching methods used in sick individuals are effective. In the national and international literature, no study has been found evaluating the effect of SC injection skill teaching based on video-supported training and low-fidelity simulation model applications on disease management in individuals diagnosed with Type 2 Diabetes Mellitus. In this regard, the research was planned as an experimental design in order to examine the effectiveness of video-supported training and low-fidelity simulation model-based teaching in gaining safe insulin injection skills via SC. For this purpose; It is aimed to evaluate the effect of two different skill teaching methods on the patient's SC injection ability, complication management and blood glucose level.

Purpose: This research was planned as an experimental design to examine the effectiveness of two different teaching methods (video-supported training and low-fidelity simulation model) in gaining safe insulin injection skills via the Subcutaneous (SC) route.

Design: A pretest-posttest two-group, quasi-experimental design will be used in the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Complication of Injection
• Intervention / Treatment: Other: video-assisted training group; Other: low fidelity simulation model group

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azzet YÜKSEL; Phone Number: +905549973894; Email: azzet.yuksel@kocaelisaglik.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The patient must be 18 years of age or older,
• Have the physical and mental ability to accurately evaluate the Visual Analog Scale (VAS),
• The platelet count is 100 000/mm3 and above,
• Having a diagnosis of Type 2 Diabetes Mellitus,
• No dementia according to Mini-Cog test evaluation,
• The plan was to agree to participate in the study.

Exclusion Criteria:

• Having verbal and auditory problems,
• Using oral or SC anticoagulant
• Presence of any findings such as scarring, incision, ecchymosis, hematoma, lipoarthrrophy and lipohypertrophy on the skin in the area where the injection will be made,
• Recurrent use of drugs that affect the formation of lipoatrophy and lipohypertrophy, such as octroid, corticosteroid, and antiretroviral therapy,
• It was defined as having a diagnosis of Diabetes during pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: video-assisted training group	Other: video-assisted training group; This group will be taught subcutaneous insulin injection through video-supported training.
Experimental: low fidelity simulation model group	Other: low fidelity simulation model group; This group will be taught subcutaneous insulin injection on a low-fidelity simulation model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subcutaneous injection skills	The "subcutaneous injection checklist" will be used to measure patients' ability to administer subcutaneous injection.	After 1 week, After 1 month, After 3 months
ecchymosis	"Opsite-Flexigrid Measurement Tool" will be used to measure ecchymosis that occur after subcutaneous injection.	After 1 week, After 1 month, After 3 months
hematoma	Opsite-Flexigrid Measurement Tool" will be used to measure hematoma that occur after subcutaneous injection.	After 1 week, After 1 month, After 3 months
lipoarthrrophy	Lipoatrrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.	After 1 week, After 1 month, After 3 months
lipohypertrophy	lipohypertrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.	After 1 week, After 1 month, After 3 months
pain	Pain occurring after subcutaneous injection will be measured with "visual analog scale". These values will be written into the chart.	during the first week, 1st month and the last week before the 3rd month
blood glucose level	Blood glucose values will be measured by patients with a blood glucose meter. These values will be written into the chart.	during the first week, 1st month and the last week before the 3rd month

Collaborators and Investigators

• Sponsor: Kocaeli Sağlık ve Teknoloji Üniversitesi
• Investigators: Principal Investigator: Azzet YÜKSEL, Kocaeli Sağlık ve Teknoloji Üniversitesi

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2024
• Primary Completion (Estimated): November 20, 2024
• Study Completion (Estimated): January 20, 2025

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: nursing; video-assisted training; practice skill
• Other Study ID Numbers: 0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No