Cold Application on the Subcutaneous Injection

Yuksek Ihtisas University78 enrolled

Overview

The goal of this clinical trial is to compare the effect of cold application at different periods of time on the occurrence of bruising, haematoma and pain in the subcutaneous low molecular weight heparin (LMWH) injected patients.

The study was a single-blind randomised control trial. Patients were allocated randomly to three groups: (i) Cold was applied for two minutes before the injection in the first group (n=26); (ii) Cold was applied for 5 min before the injection in the second group (n=26); and (iii) control group (n=26). All participating patients were injected 40 mg enoxaparin sodium in 0.4 ml in the pre-filled syringes using standard LMWH injection protocol. Post-injection VAS (Visual Analogue Scale) assessment and assessment of the presence and size of bruise and haematoma were conducted at 48th and 72nd hours after the injections for all groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Injection Site Bruising Bruising Pain

Interventions

Cold applicationOTHER

To evaluate the effect of cold application applied before subcutaneous low molecular weight heparin injection on post-injection pain, ecchymosis and hematoma formation.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * to receive LMWH (pre-filled syringe containing 40 mg enoxaparin sodium in 0.4 ml) treatment at least once a day * not to have any visual or auditory disorders * not to have any foreknown coagulation disorders * to have platelet, PTT and international normalized ratio (INR) values within the normal limits for beginning enoxaparin sodium injections * not to have any hematologic disorders or any bruising or injuries at the abdominal wall * to receive no injections at the abdominal site, other than the enoxaparin sodium during the research protocol * to will to participate in this study Exclusion Criteria: * to be pregnant * have bleeding in the injection site * have pain at any site of their body prior to the injection * have any incision, drain, scar tissue, lipodystrophy or infection symptoms at the abdominal site which hinder the application of injection * not to will to participate in this study

Outcomes

Primary Outcomes

Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection.

It was evaluated whether bruise occurred 2 times at 48th and 72nd hours after heparin injection.

Time frame: after 48th and 72nd hours from injection

Compare of the bruise sizes change of the patients at 48th and 72nd hours.

If bruise developed after heparin injection, its size was measured 2 times at 48th and 72nd hours and recorded.

Time frame: after 48th and 72nd hours from injection

Compare of the Visual Analogue Scale pain scores of the patients

The level of pain felt after the heparin injection administration was measured with the visual analogue scale. Visual Analogue Scale (VAS) was used to measure the extent of pain during the injection. VAS is widely used to measure the clinical symptoms such as pain, panic, depression, and fatigue. VAS consists of 100 mm on a horizontal line. On the scale "0" means no pain and "100" shows severe pain. The patients were asked to mark the extent of pain they had immediately after the subcutaneous injection on the scale with 'X'. The distance from "no pain" to the place that the patient has marked quantitatively represents the pain of the patient.

Time frame: after 1 minute from injection administration

Secondary Outcomes

Occurrence of haematoma at 48th and 72nd hours after the heparin injection.

Changes in hematoma formation were evaluated at 48 and 72 hours after heparin injection.

Time frame: after 48th and 72nd hours from injection

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.