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

The Effectiveness of Mechano-Analgesia and Cold Application

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03645369
Enrollment
165
Registered
2018-08-24
Start date
2015-03-02
Completion date
2015-12-25
Last updated
2018-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection Site Reaction, Injection Site Bruising

Keywords

subcutaneous heparin, injection pain, ecchymosis

Brief summary

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

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).

Interventions

DEVICEShotBlocker

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.

DEVICEIce pack

Ice pack containing gel

Sponsors

Istanbul Saglik Bilimleri University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

This study was conducted on receiving treatment patients in the Orthopedics and Traumatology wards of a university hospital.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensity Measure via VASImmediately after injectionThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026