Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT07253961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold-Induced Vagal Stimulation for Attenuating Venipuncture Pain in Obese Individuals
Sponsor:
Istinye University
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: