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

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.

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Key information

Conditions

Injection Site Reaction Blood Coagulation Disorders Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Ecchymosis Extravasation of Diagnostic and Therapeutic Materials Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Injection Site Bruising Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ShotBlocker

Device

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.

Ice pack

Device

Ice pack containing gel

Primary outcomes

Pain Intensity Measure via VAS

Time frame: Immediately after injection

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.

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

The Effectiveness of Mechano-Analgesia and Cold Application

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Aug 24, 2018
Registry last updated: Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed