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

NCT07253961 | Not Yet Recruiting

• 1 other identifier: venöz istinye
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  Immediately after cannulation (within ~1 minute)

Study Arms (2)

Cold Application Group

EXPERIMENTAL

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

Standard Venous Cannulation Group

PLACEBO COMPARATOR

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

Procedure: Cold Application to Lateral Neck Region

Interventions

Cold Application to Lateral Neck Region 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.

Cold Application Group; Standard Venous Cannulation Group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (3)

• Jungmann M, Vencatachellum S, Van Ryckeghem D, Vogele C. Effects of Cold Stimulation on Cardiac-Vagal Activation in Healthy Participants: Randomized Controlled Trial. JMIR Form Res. 2018 Oct 9;2(2):e10257. doi: 10.2196/10257.

  PMID: 30684416 BACKGROUND

• Agarwal A, Sinha PK, Tandon M, Dhiraaj S, Singh U. Evaluating the efficacy of the valsalva maneuver on venous cannulation pain: a prospective, randomized study. Anesth Analg. 2005 Oct;101(4):1230-1232. doi: 10.1213/01.ane.0000167270.15047.49.

  PMID: 16192551 RESULT

• Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28.

  PMID: 26885298 RESULT

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion: January 20, 2026
• Study Completion: February 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

TU (1)