Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Venous Cannulation Group | Placebo Comparator | Participants will undergo routine peripheral venous cannulation without any prior intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ilke dolgun | Contact | +905555485632 | ilkeser2004@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istinye Üniversity | Istanbul | Merkez Mahallesi | 34250 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30684416 | Background | 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. | |
| 16192551 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 26885298 | 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. |