- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05681338
Effect of the Coughing Technique During Subcutaneous Heparin Injection
Effect of the Coughing Technique During Subcutaneous Heparin Injection on Pain Severity and Individual Satisfaction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aims and objectives: The aim of this study was to examine the effect on the level of pain severity and satisfaction of patients of the medium intensity coughing technique applied to patients during the administration of subcutaneous low molecular weight heparin (LMWH) injection.
Design: This research was a prospective quasi-experimental study. Methods: It was conducted with 100 patients in the General Surgery Clinic of a university hospital in the Marmara Region of Turkey. Subcutaneous LMWH injections were administered by the same nurse to the outer side of the right and left upper arms by the standard injection technique and the medium intensity coughing technique. Immediately after the subcutaneous LMWH injection was given, a researcher who did not know which injection method had been used asked the patients to evaluate their pain levels by the Visual Analog Scale (VAS) and their satisfaction with the performance of the injection by the Visual Individual Satisfaction Scale (VISS).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nilüfer
-
Bursa, Nilüfer, Turkey, 16059
- Bursa Uludag University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participating voluntarily in the study
- Being over the age of 18,
- Having a doctor's prescription for subcutaneous low molecular weight heparin 0.6 mL treatment and not yet having begun treatment.
- Having no coagulation disorder, having no disorder that could affect pain perception, -
- Having no incision, lipodystrophy, or finding of infection at the injection site,
- Having no communication problem
Exclusion Criteria:
- Not wanting to participate in the study, or during the course of the research, wishing to withdraw from the study
- Having any condition which would affect the sensation of pain
- Not being able to agree on a place or time
- Being less than 18 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: the medium intensity coughing technique
Immediately before the subcutaneous heparin injection was given, patients were asked to cough twice at a medium level.
After that, they were asked to cough ten seconds later for a second time at the same level, and while they were coughing for the second time, the needle was inserted into the tissue.
|
The medium intensity coughing technique: Immediately before the subcutaneous LMWH injection was given, patients were asked to cough twice at a medium level.
After that, they were asked to cough ten seconds later for a second time at the same level, and while they were coughing for the second time, the needle was inserted into the tissue.
|
|
No Intervention: the standard injection technique
During the subcutaneous heparin injection, patients were not asked to perform any action, and the injection was given by the standard technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessed by Visual Analog Scale (VAS)
Time Frame: 2 months
|
In evaluating the severity of pain felt by the patients during subcutaneous injections, a 10 cm long vertical VAS was used, on which one end represented no pain, and the other end the worst possible pain.
The VAS is a commonly used pain assessment scale in clinical settings.
Pain severity measurements were evaluated in millimeters.
|
2 months
|
|
"Satisfaction assessed by the Visual Individual Satisfaction Scale (VISS)
Time Frame: 2 months
|
During the administration of the injection, an evaluation was made to determine individuals' satisfaction using the Visual Individual Satisfaction Scale, which consisted of a vertical 10 cm scale with "I'm very satisfied" written at one end of it and "I'm not at all satisfied" at the other.
The Visual Individual Satisfaction Scale incorporated the characteristics of the well-known Visual Analog Scale (VAS).
Satisfaction level measurements were evaluated in millimeters.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: 2 months
|
weight in kilograms
|
2 months
|
|
Height
Time Frame: 2 months
|
height in meters
|
2 months
|
|
BMI
Time Frame: 2 months
|
BMI in kg/m^2
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-6/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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