NCT05681338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

December 25, 2022

Last Update Submit

March 3, 2025

Conditions

Keywords

subcutaneous heparin injectioncoughing techniquepainindividual satisfactionnon-pharmacological method

Outcome Measures

Primary Outcomes (2)

  • 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

  • "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 Outcomes (3)

  • Weight

    2 months

  • Height

    2 months

  • BMI

    2 months

Study Arms (2)

the medium intensity coughing technique

EXPERIMENTAL

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.

Other: the medium intensity coughing technique

the standard injection technique

NO INTERVENTION

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

Interventions

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.

the medium intensity coughing technique

Eligibility Criteria

Age22 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University Hospital

Bursa, Nilüfer, 16059, Turkey (Türkiye)

Location

Related Publications (1)

  • Yilmaz D, Ayhan D, Yilmaz DU, Duzgun F. Effect of the coughing technique during subcutaneous heparin injection on pain severity and individual satisfaction. Rev Lat Am Enfermagem. 2023 May 15;31:e3923. doi: 10.1590/1518-8345.6504.3923. eCollection 2023.

MeSH Terms

Conditions

Hernia, InguinalPain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The measurements were carried out by the first researcher.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bursa Uludag University, Department of Nursing

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 12, 2023

Study Start

March 17, 2022

Primary Completion

May 30, 2022

Study Completion

June 30, 2022

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations