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

Complication of Injection Clinical Trial

— EETDTMSSIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389630
• Other study ID #: 0012
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: January 20, 2025

Study information

• Verified date: March 2024
• Source: Kocaeli Saglik ve Teknoloji Üniversitesi
• Contact: Azzet YÜKSEL
• Phone: +905549973894
• Email: azzet.yuksel[@]kocaelisaglik.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: January 20, 2025
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Injection

Intervention

Other:
• video-assisted training group
This group will be taught subcutaneous insulin injection through video-supported training.
• low fidelity simulation model group
This group will be taught subcutaneous insulin injection on a low-fidelity simulation model.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli Saglik ve Teknoloji Üniversitesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	lipoarthrrophy	Lipoatrrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.	After 1 week, After 1 month, After 3 months
Primary	lipohypertrophy	lipohypertrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.	After 1 week, After 1 month, After 3 months
Primary	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
Primary	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