Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose
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
調査の概要
状態
条件
介入・治療
詳細な説明
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).
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Tehran、イラン・イスラム共和国
- 募集
- Mohammad Sadegh Bagheri Baghdasht
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plasma glucose
時間枠：Up to 7 days
|
Laboratory check the Plasma glucose according to the routine of the hospital units
|
Up to 7 days
|
|
Insulin leakage
時間枠：Up to 7 days
|
The rate of insulin leakage after injection is observational
|
Up to 7 days
|
|
Pain when insulin injection
時間枠：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
|
協力者と研究者
捜査官
- スタディチェア：Esmail Heidaranlu、Baqiyatallah University of Medical Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。