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

Primary Purpose

Injection Site Reaction, Injection Site Bruising

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ShotBlocker
Ice pack
Sponsored by
Istanbul Saglik Bilimleri University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Injection Site Reaction focused on measuring subcutaneous heparin, injection pain, ecchymosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Mechano-Analgesia

    Cold Application

    Control

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2018
    Last Updated
    August 22, 2018
    Sponsor
    Istanbul Saglik Bilimleri University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03645369
    Brief Title
    Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection
    Official Title
    The Effectiveness of Mechano-Analgesia and Cold Application
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2, 2015 (Actual)
    Primary Completion Date
    March 15, 2015 (Actual)
    Study Completion Date
    December 25, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Saglik Bilimleri University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injection Site Reaction, Injection Site Bruising
    Keywords
    subcutaneous heparin, injection pain, ecchymosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    This study was conducted on receiving treatment patients in the Orthopedics and Traumatology wards of a university hospital.
    Allocation
    Non-Randomized
    Enrollment
    165 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mechano-Analgesia
    Arm Type
    Experimental
    Arm Description
    The first SC heparin injections were applied from the right abdominal region using ShotBlocker®.
    Arm Title
    Cold Application
    Arm Type
    Experimental
    Arm Description
    The second SC heparin injections were applied from the left abdominal region with an ice pack
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The second SC heparin injections were applied from the lower abdominal region without any additional application
    Intervention Type
    Device
    Intervention Name(s)
    ShotBlocker
    Intervention Description
    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
    Intervention Name(s)
    Ice pack
    Intervention Description
    Ice pack containing gel
    Primary Outcome Measure Information:
    Title
    Pain Intensity Measure via VAS
    Description
    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.
    Time Frame
    Immediately after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26263287
    Citation
    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.
    Results Reference
    result

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

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