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

November 26, 2025 updated by: İlke Dolgun, Istinye University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
        • Istinye University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-72 years
  • physical status I-III
  • Scheduled for elective surgery
  • Body Mass Index (BMI) > 30 kg/m²
  • Provided written informed consent

Exclusion Criteria:

  • Emergency surgical cases
  • Oncologic surgery
  • Pregnant patients
  • History of hand dorsum surgery or scarring
  • Psoriasis or other local skin lesions/infections at cannulation site
  • Peripheral vascular disease
  • Chronic analgesic, opioid, steroid, or gabapentinoid use
  • Substance abuse history
  • Peripheral neuropathy
  • Previous or ongoing oncologic treatment
  • Severe mental retardation or communication impairment preventing cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold Application Group
Participants will receive cold stimulation to the lateral neck region (over the sternocleidomastoid muscle) using a marble stone cooled to 0-4°C for 5 seconds immediately before peripheral venous cannulation.
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.
Placebo Comparator: Standard Venous Cannulation Group
Participants will undergo routine peripheral venous cannulation without any prior intervention.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous cannulation pain (VAS, 0-10)
Time Frame: Immediately after cannulation (within ~1 minute)
Pain intensity will be assessed once, right after peripheral venous cannulation, using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain). The score will be recorded as a continuous variable and compared between groups.
Immediately after cannulation (within ~1 minute)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

January 20, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • venöz istinye

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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