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

May 10, 2022 updated by: Seda CEVHEROĞLU, Istanbul University - Cerrahpasa (IUC)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thromboembolism is a frequently seen complication in patients who undergo long-term movement restriction and undergo surgical intervention, causing serious consequences such as pulmonary embolism . For this reason, heparin is frequently used for protective or therapeutic purposes in clinical situations where there is a risk of venous thromboembolism or thromboembolytic events . In the 1980s, low molecular weight heparin (LMWH) preparations, often administered subcutaneously (SC), were developed in order to increase the desired effect and reduce the side effects of heparin applications . It is stated in the literature that SC injection applications can be safely injected into the outer-lateral side of the upper arm, anterior aspect of the thigh, under the scapula and abdominal region . However, in the literature, it is emphasized that ecchymosis and hematoma formation is more common in SC LMWH applications, especially in the arm and thigh areas after SC injection. Therefore, in LMWH applications, it is stated that abdominal region is the most reliable injection site because it has thicker SC tissue compared to other parts of the body . In summary studies, it is recommended as the preferred site for LMWH applications due to the excess of SC fat tissue in the abdominal region, its width to allow rotation of the injection site and the lack of muscle activity .

Systemic and local complications may occur due to heparin injection by SC route. The most important local complications are; ecchymosis at the injection site, hematoma formation and local pain formation at the injection site . In this study, the frequency of ecchymosis; Kuz and Uçar (2001) 11.4%, Dursun and Balcı Akpınar (2014) 28.7%, Küçükgüçlü and Okumuş (2010) 31%, Varghese et al. (2006) 36%, Palese (2013) 38%, Yildirim and Atalay (2005) 57%, Zaybak and Khorshid (2008) reported as 64%. These treatment-related complications complicate the use of the damaged area in subsequent injections, adversely affect drug absorption, and cause physical trauma (ecchymosis, hematoma and pain) and changes in body image.

Pain is a subjective experience that can occur in very different qualities and severity. Pain experienced due to injection is generally defined as a condition that occurs as a result of mechanical trauma in the tissue and stimulates the nerve fiber ends with the entry of the needle into the tissue. Due to the presence of pain receptors in SC tissue, patients often experience discomfort and pain during and after LMWH applications. Pain during injection significantly affects the patient's non-compliance to treatment and pain after injection significantly affects the comfort and life activities of the patient by restricting the use of the extremity . One of the methods used to prevent these negative complications is cold applications.

Local cold administration reduces blood flow through vasoconstriction of the arterioles, controls bleeding and reduces ecchymosis and hematoma development . In addition, local cold application provides vasoconstriction in the tissue to which it is applied, slows blood flow and increases the viscosity of the blood, limits edema and inflammatory process, controls bleeding by reducing capillary permability, and reduces pain perception . With this localized sensory effect, attention is directed towards cold from pain, and thus pain is alleviated by the anesthetic effect of cold . In the studies carried out on the subject; It has been reported that 5 minutes of local humid cold application after SC injection results in a reduction in the severity and pain rate of ecchymosis . Küçükgüçlü and Okumuş (2010); SC indicated that two minutes of ice application to the heparin administration site before and after administration was an effective method of reducing ecchymosis and hematoma. Avşar and Kaşıkçı (2013); They found that two minutes of cold application to the SC injection site reduced ecchymosis and pain. Şendir et al. (2015) SC injection time of 30 seconds and 5 minutes before and after the injection of local ice application, effective in reducing the intensity of pain and ecchymosis was reported to be effective. Similarly, Korkmazcan (2016) emphasizes that application of local ice to the skin is effective for reducing ecchymosis, hematoma and pain in SC LMWH injections. In addition, it is reported that pre-injection coolant spray and thermo-mechanical analgesia method reduce pain intensity in LMWH applications via SC .

SC injection applications are an important part of drug applications and are frequently performed by nurses in clinical practice. Complications resulting from these applications cause physical and mental trauma in patients, they are reluctant to make the next injection, and for nurses, ecchymosis, hematoma and pain occurring at the injection site play a restrictive role in the selection of the site. This is an important problem for patients receiving heparin treatment for a long time; It is seen that different cold application methods such as ice application, cooling spray and thermo-mechanical analgesia techniques are used in heparin injections by SC route. However, there is no study on which these methods are used together and the effects of these methods are compared. This work; The aim of this study was to investigate the effect of three different cold application methods on ecchymosis and pain formation at the injection site in patients undergoing LMWH injection via SC.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Şişli, Istanbul, Turkey, 34510
        • Istanbul Unıversıty- Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient is 18 years or older,
  • Planning LMWH treatment by SC twice a day,
  • Has the physical and mental competence to correctly evaluate the Visual Analog Scale (VAS),
  • Platelet value is 100 000 / mm³ and ↑
  • Prothrombin time (INR) is between 0.87-1.20,
  • aPTT value between 22-36 (Platelet, PT and aPTT tests were evaluated considering the reference values of the kits used in the hospital)
  • No coagulation disorder,
  • Not using oral anticoagulants,
  • No scar tissue, incision, lipodystrophy or signs of infection on the skin of the abdomen to be injected,
  • No history of cold allergy,
  • Agree to participate in the research

Exclusion Criteria:

  • Patients who do not agree to participate in the study or who give up during the study and are discharged before the follow-up of SC injection activities will not be included in the sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: left lower abdominal region
5 minutes before and after application to the right upper abdominal region. local cold application
Other: ıce battery
abdominal bölgeye uygulamadan önce ve sonra 5 dk. lokal soğuk uygulama
Experimental: right upper abdominal region
Thermomechanical-analgesia device will be operated 30 seconds before the injection in the right lower abdominal region and the device will be injected by sliding the device to the side of the selected region during the injection,
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,
Experimental: left upper abdominal region
Coolant spray will be applied to the upper left abdominal region for 15 sec.
Other: local coolant spray
Coolant spray will be applied to the abdominal area for 5 seconds at a distance of 15 cm.
No Intervention: right lower abdominal region
SC injection will be applied to the left lower abdominal region without any cold application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects Of Ice Application On Pain In Patients Undergoing Subcutaneous Anticoagulant Therapy
Time Frame: 5 day

According to the randomization result;

  • Buzzy, a thermomechanical-analgesia device, was placed 30 seconds before the injection in the right upper abdominal region, and the SC injection was applied by sliding the device to the side of the selected region during the injection (Thermomechanical-Analgesia Group),
  • SC-LMWH injection was applied to the right lower abdominal region without any cold application (Control Group),
  • Local coolant spray was applied to the left upper abdominal region from a distance of 15 cm for 5 seconds (Local coolant spray group) and
  • Before and after the application to the left lower abdominal region, the cold application was performed with a cool-pack for 5 minutes (Cool-pack group).

It was used to evaluate the pain intensity of the patients during and after SC injection. The patient was asked to indicate the pain intensity on a scale immediately after the SC injection and on the 24th, 48th, and 72nd hours after the injection.
5 day
Effects Of Ice Application On Ecchymosis In Patients Undergoing Subcutaneous Anticoagulant Therapy
Time Frame: 5 day
It is a transparent measurement tool designed to measure the size of the ecchymosis formed in the SC injection site, in millimeters. Ecchymosis size was measured with the "Optite-Flexigrid Measurement Tool" in the ecchymoses formed in the 24th, 48th, and 72nd hours after SC-LMWH injection.
5 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

March 25, 2022

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU-C NURSİNG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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