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

August 22, 2018 updated by: Demet İnangil, PhD, Istanbul Saglik Bilimleri University

The Effectiveness of Mechano-Analgesia and Cold Application

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechano-Analgesia
The first SC heparin injections were applied from the right abdominal region using ShotBlocker®.
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.
Experimental: Cold Application
The second SC heparin injections were applied from the left abdominal region with an ice pack
Device: Ice pack
Ice pack containing gel
No Intervention: Control
The second SC heparin injections were applied from the lower abdominal region without any additional application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Saglik Bilimleri University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2015

Primary Completion (Actual)

March 15, 2015

Study Completion (Actual)

December 25, 2015

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108400987-67

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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