Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose

Study Overview
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Brief Summary
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This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group A and group B).In the first three days of the first week of hospitalization, in group A insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.

Detailed Description
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This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group A and group B).In the first three days of the first week of hospitalization, in group A insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units. After entering the data in SPSS20 software, the collected data will be analyzed using descriptive statistics (frequency, percentage, mean, standard deviation) and statistical tests (t-test, chi-square).

Official Title
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The Effect of Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose Control in Type - II Diabetic Patients in Baqiyatollah Hospital and Clinic, Tehran, 2019 -2020

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: 5-mm 32-gauge Insulin needles in the first three days of Intervention
* Device: 8-mm 32-gauge Insulin needles in the first three days of Intervention
* Device: 5-mm 32-gauge Insulin needles in the last three days of Intervention
* Device: 8-mm 32-gauge Insulin needles in the last three days of Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having type II diabetes Use injectable insulin for at least two years BMI >18 Lack of mental illness and mental retardation Use insulin pen Exclusion Criteria: Lack of desire to participate in the study Having a skin problem in the injection site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>In the first three days, participants in group A will inject 90-degree insulin injections using 5-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 8 mm to inject insulin. | Device: 5-mm 32-gauge Insulin needles in the first three days of Intervention<br>* 32-gauge needles with a length of 5mm to inject insulin in first three days<br>Device: 8-mm 32-gauge Insulin needles in the last three days of Intervention<br>* 32-gauge needles with a length of 8mm to inject insulin in second three days<br>|
| Experimental: GroupB<br>In the first three days, participants in group B will inject 90-degree insulin injections using 8-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 5mm to inject insulin. | Device: 8-mm 32-gauge Insulin needles in the first three days of Intervention<br>* 32-gauge needles with a length of 8mm to inject insulin in first three days<br>Device: 5-mm 32-gauge Insulin needles in the last three days of Intervention<br>* 32-gauge needles with a length of 5mm to inject insulin in second three days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose | Laboratory check the Plasma glucose according to the routine of the hospital units | Up to 7 days | 
| Insulin leakage | The rate of insulin leakage after injection is observational | Up to 7 days | 
| Pain when insulin injection | Survey severity pain when insulin injection by Visual Analogue Scale (VAS). This is a numerical scale that tells the patient the severity of their pain from one to ten. The larger the number, the more pain there is. | Up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Glucose, Diabetes Mellitus, Type 2, Pain, leakage, insulin injections