The Effect of Vibration on Pain During Subcutaneous Heparin Injection

Bursa Uludag University

Status: Completed

Conditions: Chest Disorder; Asthma; Pulmonary Disease; Pain

Treatments: Other: Placebo; Device: Vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT06469112

2023-28/1

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

93 participants in 3 patient groups, including a placebo group

Experimental: Vibration Application Group

Experimental group

Description:

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.

Treatment:

Device: Vibration

Placebo: Intervention Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Control: Nonintervention Group

No Intervention group

Description:

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.