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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Venipuncture Pain Vagal Nerve Stimulation Cold Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cold Application to Lateral Neck Region

Intervention Type PROCEDURE

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.

Standard Venous Cannulation Group

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

Group Type PLACEBO_COMPARATOR

Cold Application to Lateral Neck Region

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No