Complication of InjectionEETDTMSSİSNCT06389630
Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills
A study testing video-assisted training group and low fidelity simulation model group in people with Complication of Injection, run by Kocaeli Sağlık ve Teknoloji Üniversitesi.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Injection
- What is being tested?
- video-assisted training group and low fidelity simulation model group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 29 Apr 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Complication of Injection
- Being tested
- video-assisted training group, low fidelity simulation model group
- Keywords
- video-assisted training, practice skill, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-assisted training groupOther
This group will be taught subcutaneous insulin injection through video-supported training.
low fidelity simulation model groupOther
This group will be taught subcutaneous insulin injection on a low-fidelity simulation model.
| Study group | Role | What they receive |
|---|---|---|
| video-assisted training group | Experimental | Not described Receives: Other: video-assisted training group |
| low fidelity simulation model group | Experimental | Not described Receives: Other: low fidelity simulation model group |
What is being measured
The primary outcome is the main question the study is designed to answer.
subcutaneous injection skills
The "subcutaneous injection checklist" will be used to measure patients' ability to administer subcutaneous injection.
Measured: 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.
Measured: 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.
Measured: After 1 week, After 1 month, After 3 months
lipoarthrrophy
Lipoatrrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.
Measured: After 1 week, After 1 month, After 3 months
lipohypertrophy
lipohypertrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.
Measured: 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.
Measured: 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.
Measured: during the first week, 1st month and the last week before the 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start29 Apr 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azzet Yüksel, Kocaeli Sağlık ve Teknoloji Üniversitesi
- Investigators
- Azzet YÜKSEL, Principal investigator, Kocaeli Sağlık ve Teknoloji Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389630
- Sponsor's protocol ID
- 0012
- Acronym
- EETDTMSSİS
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT06389630
- Acronym / sponsor ID
- EETDTMSSİS / 0012
- Conditions
- Complication of Injection
- Keywords
- video-assisted training, practice skill, nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji ÜniversitesiUniversity, hospital or other
- Study start
- 29 Apr 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video-assisted training group | Experimental | Other: video-assisted training group |
| low fidelity simulation model group | Experimental | Other: low fidelity simulation model group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video-assisted training groupThis group will be taught subcutaneous insulin injection through video-supported training. | Other | video-assisted training group |
| low fidelity simulation model groupThis group will be taught subcutaneous insulin injection on a low-fidelity simulation model. | Other | low fidelity simulation model group |
Primary outcome
subcutaneous injection skills
Time frame: After 1 week, After 1 month, After 3 months
The "subcutaneous injection checklist" will be used to measure patients' ability to administer subcutaneous injection.
ecchymosis
Time frame: After 1 week, After 1 month, After 3 months
"Opsite-Flexigrid Measurement Tool" will be used to measure ecchymosis that occur after subcutaneous injection.
hematoma
Time frame: After 1 week, After 1 month, After 3 months
Opsite-Flexigrid Measurement Tool" will be used to measure hematoma that occur after subcutaneous injection.
lipoarthrrophy
Time frame: After 1 week, After 1 month, After 3 months
Lipoatrrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.
lipohypertrophy
Time frame: After 1 week, After 1 month, After 3 months
lipohypertrophy occurring after subcutaneous insulin injection will be determined by inspection and palpation.
pain
Time frame: during the first week, 1st month and the last week before the 3rd month
Pain occurring after subcutaneous injection will be measured with "visual analog scale". These values will be written into the chart.
blood glucose level
Time frame: during the first week, 1st month and the last week before the 3rd month
Blood glucose values will be measured by patients with a blood glucose meter. These values will be written into the chart.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azzet YÜKSEL principal investigator
Kocaeli Sağlık ve Teknoloji Üniversitesi
Questions about this trial
What is this clinical trial studying?
A study testing video-assisted training group and low fidelity simulation model group in people with Complication of Injection, run by Kocaeli Sağlık ve Teknoloji Üniversitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azzet YÜKSEL (+905549973894, azzet.yuksel@kocaelisaglik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subcutaneous injection skills (time frame: After 1 week, After 1 month, After 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.