Cold Application on the Subcutaneous Injection

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Injection Site Bruising; Bruising
• Intervention / Treatment: Other: Cold application

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group with two-minute pre-injection application of cold; 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.	Other: Cold application; To evaluate the effect of cold application applied before subcutaneous low molecular weight heparin injection on post-injection pain, ecchymosis and hematoma formation.
Active Comparator: Group with five-minute pre-injection application of cold; 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.	Other: Cold application; To evaluate the effect of cold application applied before subcutaneous low molecular weight heparin injection on post-injection pain, ecchymosis and hematoma formation.
No Intervention: Control group; Without applying any tools or processes, the low molecular weight heparin injection was applied 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	after 1 minute from injection administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after 48th and 72nd hours from injection

Collaborators and Investigators

• Sponsor: Yuksek Ihtisas University
• Collaborators: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Cevahir İlkim BULDAK, ilkimbuldak@yiu.edu.tr

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: March 4, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pain; nursing; low molecular weight heparin; subcutaneous injection; bruising; cold application; haematoma
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating; Contusions
• Other Study ID Numbers: Cold App

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No