Low-Molecular-Weight Heparin Injection in Stroke Patients

NCT ID: NCT06076434

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-05-15

Brief 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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Effect of 10 second Pressure Times on Bruising and Pain

The patients were randomized according to age and gender and included in the groups.

Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film.

Group Type: EXPERIMENTAL

The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region

Intervention Type: OTHER

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).

Effect of 35 second Pressure Times on Bruising and Pain

The patients were randomized according to age and gender and included in the groups.

Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film.

Group Type: EXPERIMENTAL

The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region

Intervention Type: OTHER

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).

Effect of 60 second Pressure Times on Bruising and Pain

The patients were randomized according to age and gender and included in the groups.

Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film.

Group Type: EXPERIMENTAL

The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kastamonu University

OTHER

Sponsor Role: lead

Responsible Party

Canan Kas

PhD, MSc, RN, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kastamonu University

Kastamonu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-KEAK-102

Identifier Type: -

Identifier Source: org_study_id