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Effect of the Coughing Technique During Subcutaneous Heparin Injection

Primary Purpose

Thyroidectomy, Colon Surgery, Cholecystectomy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
the medium intensity coughing technique
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroidectomy focused on measuring subcutaneous heparin injection, coughing technique, pain, individual satisfaction, non-pharmacological method

Eligibility Criteria

22 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bursa Uludag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the medium intensity coughing technique

the standard injection technique

Arm Description

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.

During the subcutaneous heparin injection, patients were not asked to perform any action, and the injection was given by the standard technique.

Outcomes

Primary Outcome Measures

Pain assessed by Visual Analog Scale (VAS)
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.
"Satisfaction assessed by the Visual Individual Satisfaction Scale (VISS)
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.

Secondary Outcome Measures

Weight
weight in kilograms
Height
height in meters
BMI
BMI in kg/m^2

Full Information

First Posted
December 25, 2022
Last Updated
January 11, 2023
Sponsor
Uludag University
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1. Study Identification

Unique Protocol Identification Number
NCT05681338
Brief Title
Effect of the Coughing Technique During Subcutaneous Heparin Injection
Official Title
Effect of the Coughing Technique During Subcutaneous Heparin Injection on Pain Severity and Individual Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag 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
Objective: to examine the effect of the medium intensity coughing technique during subcutaneous low molecular weight heparin injection on pain severity and individual satisfaction in general surgery patients. Method: a prospective, quasi-experimental study included 100 patients who had prescribed a subcutaneous low molecular weight heparin injection once in 24 hours. Each patient received two injections by the same researcher using standard injection technique with medium intensity coughing technique and only standard injection technique.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Colon Surgery, Cholecystectomy, Inguinal Hernia
Keywords
subcutaneous heparin injection, coughing technique, pain, individual satisfaction, non-pharmacological method

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Masking Description
The measurements were carried out by the first researcher.
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the medium intensity coughing technique
Arm Type
Experimental
Arm Description
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.
Arm Title
the standard injection technique
Arm Type
No Intervention
Arm Description
During the subcutaneous heparin injection, patients were not asked to perform any action, and the injection was given by the standard technique.
Intervention Type
Other
Intervention Name(s)
the medium intensity coughing technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessed by Visual Analog Scale (VAS)
Description
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.
Time Frame
2 months
Title
"Satisfaction assessed by the Visual Individual Satisfaction Scale (VISS)
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Weight
Description
weight in kilograms
Time Frame
2 months
Title
Height
Description
height in meters
Time Frame
2 months
Title
BMI
Description
BMI in kg/m^2
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bursa Uludag University Hospital
City
Bursa
State/Province
Nilüfer
ZIP/Postal Code
16059
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of the Coughing Technique During Subcutaneous Heparin Injection

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