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

2020年7月5日 更新者:Mohammad Sadegh Bagheri Baghdasht、Baqiyatallah Medical Sciences University

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

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.

研究概览

详细说明

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).

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group "A"
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.
32-gauge needles with a length of 5mm to inject insulin in first three days
32-gauge needles with a length of 8mm to inject insulin in second three days
实验性的:Group"B"
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.
32-gauge needles with a length of 8mm to inject insulin in first three days
32-gauge needles with a length of 5mm to inject insulin in second three days

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Plasma glucose
大体时间:Up to 7 days
Laboratory check the Plasma glucose according to the routine of the hospital units
Up to 7 days
Insulin leakage
大体时间:Up to 7 days
The rate of insulin leakage after injection is observational
Up to 7 days
Pain when insulin injection
大体时间:Up to 7 days
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Esmail Heidaranlu、Baqiyatallah University of Medical Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年5月25日

初级完成 (预期的)

2020年6月29日

研究完成 (预期的)

2020年9月25日

研究注册日期

首次提交

2020年5月10日

首先提交符合 QC 标准的

2020年7月5日

首次发布 (实际的)

2020年7月7日

研究记录更新

最后更新发布 (实际的)

2020年7月7日

上次提交的符合 QC 标准的更新

2020年7月5日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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