The Effect of Vibration on Pain During Subcutaneous Heparin Injection

Not Applicable

Completed

• Conditions: Pulmonary Disease; Chest Disorder; Pain; Asthma
• Interventions: Device: Vibration; Other: Placebo

• Registration Number: NCT06469112
• Lead Sponsor: Uludag University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-05-14
• Study Completion: 2024-05-14
• Study First Submitted: 2024-06-16
• Study First Submitted QC: 2024-06-16
• Study First Posted: 2024-06-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Vibration Application Group	Vibration	With individuals in this group, device was used to provide vibration. 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. There is a motor in the body which provides vibration. The device also has ice wings behind the body, which are used to provide cold, but these were not used in this research. The device, at room temperature, was placed by the researcher 5 cm proximal to the injection site before the injection was performed. For one minute before the injection, a slight non-discomforting vibration was made, and this was continued while the injection was given. In this study, only the body of the device was used to provide vibration.
Placebo: Intervention Control Group	Placebo	The device was used with participants in this group. The device, at room temperature, was placed by the researcher 5 cm 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 Outcome Measures

Name	Time	Method
pain intensity in mm	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 Outcome Measures

Name	Time	Method
height	6 months	height in meters
weight	6 months	weight in kilograms

Trial Locations

Locations (1)

Bursa Uludag University Hospital; 🇹🇷 Bursa, Turkey