The Effect of Vibration on Pain During Subcutaneous Heparin Injection

NCT06469112 | Completed

• 1 other identifier: 2023-28/1
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Asthma; Pulmonary Disease; Chest Disorder

Keywords

Subcutaneous heparin injection; pain; non-pharmacological method; vibration

Outcome Measures

Primary Outcomes (1)

• pain intensity in mm

  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.

  6 months

Secondary Outcomes (2)

• weight

  6 months

• height

  6 months

Study Arms (3)

Experimental: Vibration Application Group

EXPERIMENTAL

With individuals in this group, device will be 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 will 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 will performed. For one minute before the injection, a slight non-discomforting vibration will make, and this will be continue while the injection was given. In this study, only the body of the device will be used to provide vibration.

Device: Vibration

Placebo: Intervention Control Group

PLACEBO COMPARATOR

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.

Other: Placebo

Control: Nonintervention Group

NO INTERVENTION

No intervention was performed before or during the procedure with the participants in the control group, and the standard subcutaneous heparin injection procedure was carried out.

Interventions

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.

Experimental: Vibration Application Group

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.

Placebo: Intervention Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Asthma; Lung Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Bursa Uludag University, Department of Nursing

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: December 1, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-01

Locations

TU (1)