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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05681338
Other study ID # 2022-6/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2022
Est. completion date June 30, 2022

Study information

Verified date January 2023
Source Uludag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 22 Years to 86 Years
Eligibility 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 Design


Intervention

Other:
the medium intensity coughing technique
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.

Locations

Country Name City State
Turkey Bursa Uludag University Hospital Bursa Nilüfer

Sponsors (1)

Lead Sponsor Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 months
Primary "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. 2 months
Secondary Weight weight in kilograms 2 months
Secondary Height height in meters 2 months
Secondary BMI BMI in kg/m^2 2 months
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