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

NCT ID: NCT03645369

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-02
• Study Completion Date: 2015-12-25

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).

Conditions

Injection Site Reaction; Injection Site Bruising

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mechano-Analgesia

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

Group Type: EXPERIMENTAL

ShotBlocker

Intervention Type: 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.

Cold Application

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

Group Type: EXPERIMENTAL

Ice pack

Intervention Type: DEVICE

Ice pack containing gel

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Ice pack

Ice pack containing gel

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: lead

Responsible Party

Demet İnangil, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 26263287 (View on PubMed)

Other Identifiers

108400987-67

Identifier Type: -

Identifier Source: org_study_id