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

NCT06389630 | Not Yet Recruiting

• 1 other identifier: 0012
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complication of Injection

Keywords

video-assisted training; practice skill; nursing

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

video-assisted training group

EXPERIMENTAL

Other: video-assisted training group

low fidelity simulation model group

EXPERIMENTAL

Other: low fidelity simulation model group

Interventions

video-assisted training group OTHER

This group will be taught subcutaneous insulin injection through video-supported training.

video-assisted training group

low fidelity simulation model group OTHER

This group will be taught subcutaneous insulin injection on a low-fidelity simulation model.

low fidelity simulation model group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli Sağlık ve Teknoloji Üniversitesi: lead

Study Officials

• Azzet YÜKSEL

  Kocaeli Sağlık ve Teknoloji Üniversitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azzet YÜKSEL

CONTACT

+905549973894; azzet.yuksel@kocaelisaglik.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer,Principal Investigator

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 29, 2024
• Study Start: April 29, 2024
• Primary Completion: November 20, 2024
• Study Completion: January 20, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share