CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Thermo mechanical device +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04235244
NCT04235244N/ACompleted

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

Istanbul University - Cerrahpasa·interventional·Posted Jan 21, 2020·Updated May 16, 2022

In Brief

A clinical study evaluating Thermo mechanical device, local coolant spray, and 1 other intervention for Pain and Ecchymosis. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Ecchymosis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 21, 2020
Enrollment StartJun 1, 2020
Primary CompletionAug 30, 2020
Study CompletionMar 25, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.4 years ago

Interventions

Thermo mechanical deviceother

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,

local coolant sprayother

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

ıce batteryother

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