Cold-Induced Vagal Stimulation for Attenuating Venipuncture Pain in Obese Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cold Application to Lateral Neck Region.
- Who it may be relevant to
- Registry conditions: Venipuncture Pain, Vagal Nerve Stimulation, Cold Stimulation. Basic parameters: 18 years — 72 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- Venous cannulation pain (VAS, 0-10) [Time frame: Immediately after cannulation (within ~1 minute)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Turkey (Türkiye) · 1 center
- Istinye Üniversity — Istanbul
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07253961 · venöz istinye