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Completed

NCT Number: NCT06469112

The Effect of Vibration on Pain During Subcutaneous Heparin Injection

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.

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Key information

Conditions

Pain Asthma Bronchial Diseases Chest Disorder Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pulmonary Disease Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludag University Hospital

Bursa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vibration

Device

The device was used to provide vibration with the participants in this group. This device, designed as a combination of cold application and local vibration to reduce pain experienced during invasive procedures, is frequently chosen for all age groups.

Placebo

Other

The device was used with participants in this group. The device, at room temperature, was placed by the researcher 5cm proximal to the injection site before the injection was performed. With participants in this group, the device was placed on the procedure site, but no vibration was made. The device was held on the participants for one minute before the injection and throughout the procedure, with the vibration switched off.

Primary outcomes

  1. 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

  1. weight

    Time frame: 6 months

    weight in kilograms

  2. height

    Time frame: 6 months

    height in meters

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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