Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)
NCT Number: NCT07253961
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.
Trial opening soon.
Get Notified18 year–72 year
All sexes
Interventional
Not applicable
Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Istinye University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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