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| Name | Class |
|---|---|
| Saglik Bilimleri Universitesi | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of haematoma at 48th and 72nd hours after the heparin injection. | Changes in hematoma formation were evaluated at 48 and 72 hours after heparin injection. | after 48th and 72nd hours from injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cevahir İlkim BULDAK | ilkimbuldak@yiu.edu.tr | Principal Investigator |
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| ID | Term |
|---|---|
| D003288 | Contusions |
| D010146 | Pain |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |