The Effect of Vibration on Pain During Subcutaneous Heparin Injection

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06469112
• Other study ID #: 2023-28/1
• Status: Completed
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: May 2024
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: The aim of this research was 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 were randomly assigned to an experimental (vibration) group (n= 32), a placebo control group (n= 30), and a nonintervention control group (n= 31). Participants in the experimental group were given slight vibration to the injection site before the injection was administered; for participants in the placebo group, the device was 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 was administered. The level of pain felt by the participants during the administration of the injection was assessed with a visual analog scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Lung Diseases
• Pain
• Pulmonary Disease

Intervention

Device:
• Vibration
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity in mm	A 10-cm vertical VAS was 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. Pain severity was evaluated in millimeters.	6 months
Secondary	weight	weight in kilograms	6 months
Secondary	height	height in meters	6 months