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

NCT04235244 | Completed DMC

• 1 other identifier: IU-C NURSİNG
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Pain; Ecchymosis

Keywords

subcutaneous ınjectıon; cold application; pain; ecchymosis; heparin injection

Outcome Measures

Primary Outcomes (2)

• Effects Of Ice Application On Pain In Patients Undergoing Subcutaneous Anticoagulant Therapy

  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

  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

Study Arms (4)

left lower abdominal region

EXPERIMENTAL

5 minutes before and after application to the right upper abdominal region. local cold application

Other: ıce battery

right upper abdominal region

EXPERIMENTAL

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

left upper abdominal region

EXPERIMENTAL

Coolant spray will be applied to the upper left abdominal region for 15 sec.

Other: local coolant spray

right lower abdominal region

NO INTERVENTION

SC injection will be applied to the left lower abdominal region without any cold application.

Interventions

Thermo mechanical device OTHER

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,

right upper abdominal region

local coolant spray OTHER

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

left upper abdominal region

ıce battery OTHER

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

left lower abdominal region

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Unıversıty- Cerrahpaşa

Şişli, Istanbul, 34510, Turkey (Türkiye)

Location

Related Publications (9)

• Sendir M, Buyukyilmaz F, Celik Z, Taskopru I. Comparison of 3 methods to prevent pain and bruising after subcutaneous heparin administration. Clin Nurse Spec. 2015 May-Jun;29(3):174-80. doi: 10.1097/NUR.0000000000000129.

  PMID: 25856035 RESULT

• Akbari Sari A, Janani L, Mohammady M, Nedjat S. Slow versus fast subcutaneous heparin injections for prevention of bruising and site-pain intensity. Cochrane Database Syst Rev. 2014 Jul 18;(7):CD008077. doi: 10.1002/14651858.CD008077.pub3.

  PMID: 25036897 RESULT

• Collado-Mesa F, Net JM, Arheart K, Klevos GA, Yepes MM. Application of a topical vapocoolant spray decreases pain at the site of initial intradermal anaesthetic injection during ultrasound-guided breast needle biopsy. Clin Radiol. 2015 Sep;70(9):938-42. doi: 10.1016/j.crad.2015.04.013. Epub 2015 Jul 7.

  PMID: 26162573 RESULT

• Palese A, Aidone E, Dante A, Pea F. Occurrence and extent of bruising according to duration of administration of subcutaneous low-molecular-weight heparin: a quasi-experimental case-crossover study. J Cardiovasc Nurs. 2013 Sep-Oct;28(5):473-82. doi: 10.1097/JCN.0b013e3182578b87.

  PMID: 22760174 RESULT

• Mohammady M, Janani L, Akbari Sari A. Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity. Cochrane Database Syst Rev. 2017 Nov 1;11(11):CD008077. doi: 10.1002/14651858.CD008077.pub5.

  PMID: 29090459 RESULT

• Cengiz Z, Ozkan M. Comparison of abdominal and arm areas in patients receiving subcutaneous heparin in terms of development of pain, hematoma, and ecchymosis. J Vasc Nurs. 2018 Dec;36(4):208-215. doi: 10.1016/j.jvn.2018.06.003. Epub 2018 Jul 10.

  PMID: 30458944 RESULT

• Zaybak A, Khorshid L. A study on the effect of the duration of subcutaneous heparin injection on bruising and pain. J Clin Nurs. 2008 Feb;17(3):378-85. doi: 10.1111/j.1365-2702.2006.01933.x. Epub 2007 Oct 11.

  PMID: 17931375 RESULT

• Kuzu N, Ucar H. The effect of cold on the occurrence of bruising, haematoma and pain at the injection site in subcutaneous low molecular weight heparin. Int J Nurs Stud. 2001 Feb;38(1):51-9. doi: 10.1016/s0020-7489(00)00061-4.

  PMID: 11137723 RESULT

• Balci Akpinar R, Celebioglu A. Effect of injection duration on bruising associated with subcutaneous heparin: a quasi-experimental within-subject design. Int J Nurs Stud. 2008 Jun;45(6):812-7. doi: 10.1016/j.ijnurstu.2007.02.005. Epub 2007 Mar 30.

  PMID: 17399715 RESULT

Related Links

• PREVENTION OF PAIN, BRUISE AND HEMATOMA ON SUBCUTANEOUS HEPARIN INJECTION: A SYSTEMATIC REVIEW

MeSH Terms

Conditions

Pain; Ecchymosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All SC injections, ecchymosis measurements, VAS evaluation and post-injection follow-up will be performed by the researcher. Immediately after injection, pain intensity at 24, 48 and 72 hours and ecchymosis at 24, 48 and 72 hours will be evaluated
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD of Nursing / Senior Instructor Department of Nursing Faculty of Health Sciences

Model Details: It will be determined by simple randomization method which SC injection will be applied to these four regions. According to the results of randomization; * 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 * SC-LMWH injection was applied to the right lower abdominal region without any cold application * Local coolant spray was applied to the left upper abdominal region from a distance of 15 cm for 5 seconds and * Before and after the application to the left lower abdominal region, the cold application was performed with a cool-pack for 5 minutes. The application of 2x0.6cc standard ready-to-use injectable Enoxiparin, which was requested by the physician according to the SC injection application steps, was applied together with the cold application method determined by randomization.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: June 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: March 25, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR

Locations

TU (1)