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

5. juli 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 5-mm 32-gauge Insulin needles in the first three days of Intervention
32-gauge needles with a length of 5mm to inject insulin in first three days
Enhed: 8-mm 32-gauge Insulin needles in the last three days of Intervention
32-gauge needles with a length of 8mm to inject insulin in second three days
Eksperimentel: 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.
Enhed: 8-mm 32-gauge Insulin needles in the first three days of Intervention
32-gauge needles with a length of 8mm to inject insulin in first three days
Enhed: 5-mm 32-gauge Insulin needles in the last three days of Intervention
32-gauge needles with a length of 5mm to inject insulin in second three days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma glucose
Tidsramme: Up to 7 days
Laboratory check the Plasma glucose according to the routine of the hospital units
Up to 7 days
Insulin leakage
Tidsramme: Up to 7 days
The rate of insulin leakage after injection is observational
Up to 7 days
Pain when insulin injection
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baqiyatallah Medical Sciences University

Efterforskere

  • Studiestol: Esmail Heidaranlu, Baqiyatallah University of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. maj 2020

Primær færdiggørelse (Forventet)

29. juni 2020

Studieafslutning (Forventet)

25. september 2020

Datoer for studieregistrering

Først indsendt

10. maj 2020

Først indsendt, der opfyldte QC-kriterier

5. juli 2020

Først opslået (Faktiske)

7. juli 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IR.BMSU.BAQ.REC.1398.059

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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