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Clinical Trials/NCT06469112
NCT06469112
Completed
N/A

The Effect of Vibration on Pain During Subcutaneous Heparin Injection: A Randomized Controlled Study

Uludag University1 site in 1 country93 target enrollmentDecember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Uludag University
Enrollment
93
Locations
1
Primary Endpoint
pain intensity in mm
Status
Completed
Last Updated
last year

Overview

Brief Summary

Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.

Methods: The patients will randomly assigned to an experimental (vibration) group , a placebo control group, and a nonintervention control group. Participants in the experimental group will give slight vibration to the injection site before the injection will administered; for participants in the placebo group, the device will placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection will administered. The level of pain felt by the participants during the administration of the injection will assess with a visual analog scale.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
May 14, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uludag University
Responsible Party
Principal Investigator
Principal Investigator

Dilek Yilmaz, PhD

Associate Professor, Bursa Uludag University, Department of Nursing

Uludag University

Eligibility Criteria

Inclusion Criteria

  • being over the age of 18
  • having a doctor's prescription for subcutaneousheparin 0.6 mL treatment with a ready-to-use syringe and not yet having begun treatment
  • having no coagulation disorder
  • having no disorder which could affect pain perception,
  • having no incision, lipodystrophy or finding of infection at the injection site,
  • having no communication problem, and voluntarily agreeing to participate in the research

Exclusion Criteria

  • being under the age of 18
  • having diabetes mellitus
  • peripheral vascular disease, etc. which could affect the perception of pain
  • not being conscious, refusing to participate in the research or opting to leave the study at any point.

Outcomes

Primary Outcomes

pain intensity in mm

Time Frame: 6 months

A 10-cm vertical VAS will used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible.

Secondary Outcomes

  • height(6 months)
  • weight(6 months)

Study Sites (1)

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