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Completed

NCT Number: NCT05771285

Cold Application on the Subcutaneous Injection

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.

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Key information

Conditions

Injection Site Bruising Bruising Contusions Hematoma Hemorrhage Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Application

Other

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

Primary outcomes

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

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

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

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

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

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

  3. Compare of the Visual Analogue Scale pain scores of the patients

    Time frame: after 1 minute from injection administration

    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.

Secondary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas University

Other

Collaborators

  • Saglik Bilimleri Universitesi

Registry information

Official study title

The Effect of Cold Application on the Occurrence of Bruising, Hematoma and Pain in the Subcutaneous Low Molecular Weight Heparin Injection: a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2023
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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