Cold Application on the Subcutaneous Injection

Not Applicable

Completed

• Conditions: Injection Site Bruising; Bruising; Pain
• Interventions: Other: Cold application

• Registration Number: NCT05771285
• Lead Sponsor: Yuksek Ihtisas University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-01
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Study First Submitted: 2022-12-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-04
• Last Update Submitted: 2023-03-04
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with two-minute pre-injection application of cold	Cold application	Before applying the subcutaneous injection, cold application pack was applied on the injection site for two minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.
Group with five-minute pre-injection application of cold	Cold application	Before applying the subcutaneous injection, cold application pack was applied on the injection site for five minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.

Primary Outcome Measures

Name	Time	Method
Compare of the bruise sizes change of the patients at 48th and 72nd hours.	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.
Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection.	after 48th and 72nd hours from injection	It was evaluated whether bruise occurred 2 times at 48th and 72nd hours after heparin injection.
Compare of the Visual Analogue Scale pain scores of the patients	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 Outcome Measures

Name	Time	Method
Occurrence of haematoma at 48th and 72nd hours after the heparin injection.	after 48th and 72nd hours from injection	Changes in hematoma formation were evaluated at 48 and 72 hours after heparin injection.