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

Istinye University

Status: Not yet enrolling

Conditions: Cold Stimulation; Vagal Nerve Stimulation; Venipuncture Pain

Treatments: Procedure: Cold Application to Lateral Neck Region

Study type: Interventional

Funder types: Other

Identifiers

NCT07253961

venöz istinye

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Cold Application Group

Experimental group

Description:

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.

Treatment:

Procedure: Cold Application to Lateral Neck Region

Standard Venous Cannulation Group

Placebo Comparator group

Description:

Participants will undergo routine peripheral venous cannulation without any prior intervention.

Treatment:

Procedure: Cold Application to Lateral Neck Region