Cold Application on the Subcutaneous Injection

Yuksek Ihtisas University

Status: Completed

Conditions: Bruising; Injection Site Bruising; Pain

Treatments: Other: Cold application

Study type: Interventional

Funder types: Other

Identifiers

NCT05771285

Cold App

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 3 patient groups

Group with two-minute pre-injection application of cold

Active Comparator group

Description:

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.

Treatment:

Other: Cold application

Group with five-minute pre-injection application of cold

Active Comparator group

Description:

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.

Treatment:

Other: Cold application

Control group

No Intervention group

Description:

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.