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

NCT03645369 | Completed

• 1 other identifier: 108400987-67
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Injection Site Reaction; Injection Site Bruising

Keywords

subcutaneous heparin; injection pain; ecchymosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Mechano-Analgesia

EXPERIMENTAL

The first SC heparin injections were applied from the right abdominal region using ShotBlocker®.

Device: ShotBlocker

Cold Application

EXPERIMENTAL

The second SC heparin injections were applied from the left abdominal region with an ice pack

Device: Ice pack

Control

NO INTERVENTION

The second SC heparin injections were applied from the lower abdominal region without any additional application

Interventions

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.

Mechano-Analgesia

Ice pack DEVICE

Ice pack containing gel

Cold Application

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Related Publications (1)

• Celik 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.

  PMID: 26263287 RESULT

MeSH Terms

Conditions

Injection Site Reaction; Ecchymosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study was conducted on receiving treatment patients in the Orthopedics and Traumatology wards of a university hospital.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 24, 2018
• Study Start: March 2, 2015
• Primary Completion: March 15, 2015
• Study Completion: December 25, 2015
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share