Cold Application on the Subcutaneous Injection

NCT ID: NCT05771285

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-06-30

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.

Conditions

Injection Site Bruising; Bruising; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cold application

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Cold application

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: collaborator

Yuksek Ihtisas University

OTHER

Sponsor Role: lead

Responsible Party

cevahir ilkim buldak

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cevahir İlkim BULDAK

Role: PRINCIPAL_INVESTIGATOR

ilkimbuldak@yiu.edu.tr

Other Identifiers

Cold App

Identifier Type: -

Identifier Source: org_study_id