Low-Molecular-Weight Heparin Injection in Stroke Patients

Stroke Clinical Trial

Official title:

The Effect on Bruising and Pain of Different Durations of Pressure Application Following Subcutaneous Heparin Injection to the Upper Arm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06076434
• Other study ID #: 2022-KEAK-102
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: October 2023
• Source: Kastamonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bruising as a result of heparin injection increases patients' anxiety, decreases their confidence in the effectiveness of nurses and causes them to refuse the injection. This undesirable effect can be reduced by using appropriate technique and taking a few simple precautions. In the systematic review conducted by İnangil and Şendir (2017) to systematically review the studies on the prevention of ecchymosis, hematoma and pain associated with subcutaneous heparin injection; it was determined that the number of studies investigating other techniques (pressure, site selection, etc.) was insufficient, with the highest number of studies on injection time and cold application. As a result of the research, it was recommended that local pressure should be applied to the area after injection, and the abdominal region should be preferred especially in patients who are sensitive to pain, since pain intensity is higher in the thigh and arm region. Due to the lack of literature, there is no consensus regarding the duration of compression to reduce bruising and pain after LMWH application. Based on these, this study was planned to compare the pressure applied to the injection point for 10, 35 and 60 seconds after injection in terms of pain, bruising and development of ecchymosis and hematoma at the injection sites in patients using subcutaneous heparin in the upper arm.

Description:

Anticoagulants are medicines that prevent blood from clotting as quickly or effectively as normal. Can be administered IV or subcutaneously. The main complications of heparin therapy are bleeding, thrombocytopenia and osteoporosis. Anticoagulants are classified as Vitamin K antagonist (VKA) (oral), Unfractionated heparin (UFH) (IV or subcutaneous), LMWHD (subcutaneous), Heparinoids (IV or subcutaneous), Fondaparinux (Subcutaneous), Oral factor Xa inhibitors, Parenteral direct thrombin inhibitors and Oral direct thrombin inhibitors. Subcutaneous administration of low-molecular-weight heparin (LMWH) may cause complications such as hematoma, bruising and pain at different injection sites. It is a goal of the nurse to reduce discomfort, anxiety, worry, refusal of treatment and lack of trust in the nurse due to bruising on the skin. Several studies have been conducted to investigate whether bruising and pain depend on injection sites; however, the results are conflicting and no clear and consistent conclusion has been reached. Subcutaneous heparin injection is a common nursing clinical intervention. Nurses often inject heparin subcutaneously and this action often causes some complications such as bruising, hematoma, pain and induration at the injection site. Bruising as a result of heparin injection increases patients' anxiety, decreases their confidence in the effectiveness of nurses and causes them to refuse the injection. This undesirable effect can be reduced by using appropriate technique and taking a few simple precautions. In the systematic review conducted by İnangil and Şendir (2017) to systematically review the studies on the prevention of ecchymosis, hematoma and pain associated with subcutaneous heparin injection; it was determined that the number of studies investigating other techniques (pressure, site selection, etc.) was insufficient, with the highest number of studies on injection time and cold application. As a result of the research, it was recommended that local pressure should be applied to the area after injection, and the abdominal region should be preferred especially in patients who are sensitive to pain, since pain intensity is higher in the thigh and arm region. Due to the lack of literature, there is no consensus regarding the duration of compression to reduce bruising and pain after LMWH application. Based on these, this study was planned to compare the pressure applied to the injection point for 10, 35 and 60 seconds after injection in terms of pain, bruising and development of ecchymosis and hematoma at the injection sites in patients using subcutaneous heparin in the upper arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older

• Hospitalized in the neurology clinic

• Who were administered at least once a day LMWH via subcutaneous injections in the arm

• Who agreed to participate in the study were included in this study

Exclusion Criteria:

• Patients who refused to participate in the study

• Patients with an INR value above 1.3 (hospital reference range was taken)

• Patients taking anticoagulant drugs were included in the study

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region
The injection site on the upper arm of each patient was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected into the tissue at a 90° angle with a 27 gauge needle. The heparin was injected in approximately 10 seconds without aspirating the syringe. After the injection, pressure was applied to the area with dry cotton for specified periods (10 second, 35 second and 60 second).

Locations

Country	Name	City	State
Turkey	Kastamonu University	Kastamonu

Sponsors (1)

Lead Sponsor	Collaborator
Kastamonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region	In this study, in patients using LMWH on the upper arm, the pressure applied to the injection point for 10, 35 and 60 seconds after the injection, and the pain at the injection site after the pressure were measured with the Visual Analog Scale. Additionally, in patients using LMWH on the upper arm, the pressure applied to the injection point for 10, 35 and 60 seconds after injection was examined for the development of bruising, ecchymosis and hematoma 48 hours later. Researchers marked an approximately 5 cm circle around the needle entry site using an acetate pen, and the level of bruising was measured and recorded 48 hours later using clear film.	48 hours