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

Injection Site Reaction Clinical Trial

Official title:

The Effectiveness of Mechano-Analgesia and Cold Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645369
• Other study ID #: 108400987-67
• Status: Completed
• Phase: N/A
• Start date: March 2, 2015
• Est. completion date: December 25, 2015

Study information

• Verified date: August 2018
• Source: Istanbul Saglik Bilimleri University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 25, 2015
• Est. primary completion date: March 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ecchymosis
• Injection Site Bruising
• Injection Site Reaction

Intervention

Device:
• ShotBlocker
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
Ice pack containing gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Saglik Bilimleri University

References & Publications (1)

Çelik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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