Low-Molecular-Weight Heparin Injection in Stroke Patients

NCT06076434 | Completed

• 1 other identifier: 2022-KEAK-102
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Anticoagulants; Injection; Nursing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Effect of 10 second Pressure Times on Bruising and Pain

EXPERIMENTAL

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.

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

Effect of 35 second Pressure Times on Bruising and Pain

EXPERIMENTAL

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.

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

Effect of 60 second Pressure Times on Bruising and Pain

EXPERIMENTAL

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.

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

Interventions

The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region 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 10 second Pressure Times on Bruising and Pain; Effect of 35 second Pressure Times on Bruising and Pain; Effect of 60 second Pressure Times on Bruising and Pain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Kastamonu University

Kastamonu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MSc, RN, Assistant Professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: October 10, 2023
• Study Start: November 1, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

TU (1)