NCT07253961

Cold-Induced Vagal Stimulation for Attenuating Venipuncture Pain in Obese Individuals

The Effects of Lateral Neck Cold Application for Vagal Nerve Stimulation on Pain During Peripheral Venous Cannulation in Obese Patients: A Prospective Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Istinye University · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized controlled clinical trial aims to evaluate the effect of lateral neck cold application for vagal nerve stimulation on pain perception during peripheral venous cannulation in obese patients. Venous cannulation is a routine but painful procedure, especially in individuals with a body mass index (BMI) greater than 30, who often have heightened pain sensitivity due to chronic inflammation. Participants will be randomly assigned to one of two groups: Group 1 (Cold Application Group): A cold marble stone (0-4°C) will be applied to the lateral neck region (over the sternocleidomastoid muscle) for 5 seconds immediately before venous cannulation. Group 2 (Control Group): Standard venous cannulation will be performed without any prior intervention. Pain intensity will be assessed using the Visual Analog Scale (VAS) immediately after cannulation. Hemodynamic parameters (heart rate, blood pressure, oxygen saturation, respiratory rate) will be recorded before and after the procedure. The primary outcome is the difference in VAS scores between the two groups. Secondary outcomes include changes in hemodynamic parameters. The study will enroll 150 participants over approximately two months following ethics approval.

Conditions

• Venipuncture Pain
• Vagal Nerve Stimulation
• Cold Stimulation

Interventions

Type	Name	Description
PROCEDURE	Cold Application to Lateral Neck Region	Application of a marble stone cooled to 0-4°C on the lateral neck (over the sternocleidomastoid muscle) for 5 seconds prior to venous cannulation to stimulate the vagus nerve.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-01-20
• Completion: 2026-02-01
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Turkey (Türkiye)