Cold Application on the Subcutaneous Injection

Sponsor

Yuksek Ihtisas University (Other)

Overall Status

Completed

CT.gov ID

NCT05771285

Collaborator

Saglik Bilimleri Universitesi (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Injection Site Bruising Bruising Pain	Other: Cold application	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.
No Intervention: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Active Comparator: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection. [after 48th and 72nd hours from injection]
It was evaluated whether bruise occurred 2 times at 48th and 72nd hours after heparin injection.
Compare of the bruise sizes change of the patients at 48th and 72nd hours. [after 48th and 72nd hours from injection]
If bruise developed after heparin injection, its size was measured 2 times at 48th and 72nd hours and recorded.
Compare of the Visual Analogue Scale pain scores of the patients [after 1 minute from injection administration]
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.

Secondary Outcome Measures

Occurrence of haematoma at 48th and 72nd hours after the heparin injection. [after 48th and 72nd hours from injection]
Changes in hematoma formation were evaluated at 48 and 72 hours after heparin injection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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