The Effect of Three Different Local Cold Applications on Pain and Ecchymosis in Subcutaneous Heparin Injections

NCT04235244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-05-16

No results posted yet for this study

Summary

The aim of this study was to investigate the effects of three different cold application methods on ecchymosis and pain in the injection site in patients who received DMAH injection from the SC route.

In the Turkish Republic of Northern Cyprus, the research universe will be composed of the patients who underwent DMAH from the SC path in Internal Medicine Service at a State Hospital under the Ministry of Health. The sample will consist of patients who meet the research criteria, who are informed about the purpose of the research, and who are willing to participate after obtaining the permission of the Ethics Committee and institution. The sample will consist of patients who meet the research criteria, who are informed about the purpose of the research, and who are willing to participate after obtaining the permission of the Ethics Committee and institution. The sample size (d=0.785) was found by reference from the article "effect of ice application on ecchymosis formation in patients undergoing subcutaneous anticoagulant therapy" by Küçükgüçlü and Okumu (2010) and the sample size required for 1-β=0.95 (power) in α=0.05 was n = 38.

Patient Data Sheet, SC Road injection tracking chart, Visual Analog scale, Opsite - Flexigrid measurement tool, Mekano-analgesia (Buzzy) device, local coolant spray and acetate Pen will be used for data collection.

Statistical Package for Social Sciences (SPSS) 25.0 software will be used for statistical analysis of research data. If the data set matches the normal distribution, parametric hypothesis tests will be used, and if the data set does not match the normal distribution, nonparametric hypothesis tests will be used.

Conditions

Interventions

OTHER

Thermo mechanical device

The thermomechanical-analgesia device will be placed and operated 30 seconds before the injection into the abdominal area,and injection will be applied by sliding the device to the side of the selected region during the injection,

OTHER

local coolant spray

Coolant spray will be applied to the abdominal area for 5 seconds at a distance of 15 cm.

OTHER

ıce battery

abdominal bölgeye uygulamadan önce ve sonra 5 dk. lokal soğuk uygulama

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-08-30
Completion
2022-03-25

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235244 on ClinicalTrials.gov