Cold Application on the Subcutaneous Injection

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771285
• Other study ID #: Cold App
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: March 2023
• Source: Yuksek Ihtisas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bruising
• Contusions
• Injection Site Bruising
• Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yuksek Ihtisas University	Saglik Bilimleri Universitesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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