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

NCT07253961 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-11-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Istinye University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-01-20
Completion
2026-02-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253961 on ClinicalTrials.gov