Clinical trial NCT05771285: Cold Application on the Subcutaneous Injection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Bruising
Bruising
Pain
Keywords: bruising
cold application
haematoma
low molecular weight heparin
nursing
pain
subcutaneous injection
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2023-03-16
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection.
timeFrame: after 48th and 72nd hours from injection
measure: Compare of the bruise sizes change of the patients at 48th and 72nd hours.
timeFrame: after 48th and 72nd hours from injection
measure: Compare of the Visual Analogue Scale pain scores of the patients
timeFrame: after 1 minute from injection administration
Secondary outcomes:
measure: Occurrence of haematoma at 48th and 72nd hours after the heparin injection.
timeFrame: after 48th and 72nd hours from injection
Other outcomes:
Locations:
Study officials:
affiliation: ilkimbuldak@yiu.edu.tr
name: Cevahir İlkim BULDAK
role: PRINCIPAL_INVESTIGATOR
References: