Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection

Study Overview
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Brief Summary
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Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.

Detailed Description
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The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm). All the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).

Official Title
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The Effectiveness of Mechano-Analgesia and Cold Application

Conditions
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Injection Site Reaction, Injection Site Bruising

Intervention / Treatment
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* Device: ShotBlocker
* Device: Ice pack


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be older than 18 years Open to communication No complications during the operation Normal body mass index (BMI; reference range, 18.5-29.9 kg/m2) (d) and Platelet count (150.000-300.000) Give consent to participate in the study Exclusion Criteria: Oral and parenteral anticoagulant treatment for at least 5 days Infection, scar tissue or incision, and parenteral treatment in their abdominal area Hematological and allergic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechano-Analgesia<br>The first SC heparin injections were applied from the right abdominal region using ShotBlocker®. | Device: ShotBlocker<br>* ShotBlocker is a drug-free tool with no side effects and does not require preparation. It is a flexible, plastic, C-shaped device with a number of short (2 mm) blunt contact points on its back.<br>|
| Experimental: Cold Application<br>The second SC heparin injections were applied from the left abdominal region with an ice pack | Device: Ice pack<br>* Ice pack containing gel<br>|
| No Intervention: Control<br>The second SC heparin injections were applied from the lower abdominal region without any additional application | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Measure via VAS | The VAS was used to measure pain intensity. The VAS was composed of a 10-cm long line, which had subjective descriptive expressions on both sides (0 cm: no pain and 10 cm: unbearable pain). The individual was asked to make a sign on the line indicating the degree of the pain. The numerical values were recorded by the researcher. | Immediately after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subcutaneous heparin, injection pain, ecchymosis