Cold Application on the Subcutaneous Injection

NCT05771285 | Completed

• 1 other identifier: Cold App
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Injection Site Bruising; Bruising; Pain

Keywords

bruising; cold application; haematoma; low molecular weight heparin; nursing; pain; subcutaneous injection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  after 48th and 72nd hours from injection

Study Arms (3)

Group with two-minute pre-injection application of cold

ACTIVE COMPARATOR

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

Group with five-minute pre-injection application of cold

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

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.

Group with five-minute pre-injection application of cold; Group with two-minute pre-injection application of cold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuksek Ihtisas University: lead
• Saglik Bilimleri Universitesi: collaborator

MeSH Terms

Conditions

Contusions; Pain; Hematoma

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes

Study Officials

• Cevahir İlkim BULDAK

  ilkimbuldak@yiu.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: March 16, 2023
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 16, 2023

Record last verified: 2023-03