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
About this trial
This is an interventional supportive care trial for Injection Site Reaction focused on measuring subcutaneous heparin, injection pain, ecchymosis
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
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
NCT ID
NCT03645369
First Posted
August 9, 2018
Last Updated
August 22, 2018
Sponsor
Istanbul Saglik Bilimleri University
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
Learn more about this trial
Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection
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