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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-72
SponsorIstinye University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-72 years

physical status I-III

Scheduled for elective surgery

Body Mass Index (BMI) > 30 kg/m²

Disqualifiers

Emergency surgical cases

Oncologic surgery

Pregnant patients

History of hand dorsum surgery or scarring

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cold Application to Lateral Neck Region

    Procedure/Surgery

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Cold Application GroupExperimental treatment 1 intervention
Group B: Standard Venous Cannulation GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Venous cannulation pain (VAS, 0-10)

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.

Time frame
Immediately after cannulation (within ~1 minute)

Secondary outcomes

Other outcomes

Sponsors and contacts

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