Clinical trial NCT06389630: Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills
Official title: Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Complication of Injection
Keywords: video-assisted training
practice skill
nursing
Lead sponsor: Kocaeli Sağlık ve Teknoloji Üniversitesi
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: subcutaneous injection skills
timeFrame: After 1 week, After 1 month, After 3 months
measure: ecchymosis
timeFrame: After 1 week, After 1 month, After 3 months
measure: hematoma
timeFrame: After 1 week, After 1 month, After 3 months
measure: lipoarthrrophy
timeFrame: After 1 week, After 1 month, After 3 months
measure: lipohypertrophy
timeFrame: After 1 week, After 1 month, After 3 months
measure: pain
timeFrame: during the first week, 1st month and the last week before the 3rd month
measure: blood glucose level
timeFrame: during the first week, 1st month and the last week before the 3rd month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kocaeli Sağlık ve Teknoloji Üniversitesi
name: Azzet YÜKSEL
role: PRINCIPAL_INVESTIGATOR
References: