NCT07253961Not yet recruiting
Cold-Induced Vagal Stimulation for Attenuating Venipuncture Pain in Obese Individuals
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
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 20 Jan 2026
- Lead sponsor
- Istinye University
- Diseases
- Obesity
- NCT number
- NCT07253961
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Dec 2025 to the primary completion date, 20 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgical cases
- Oncologic surgery
- Chronic analgesic, opioid, steroid, or gabapentinoid use
- Previous or ongoing oncologic treatment
Other illness
- History of hand dorsum surgery or scarring
- Psoriasis or other local skin lesions/infections at cannulation site
- Peripheral vascular disease
- Severe mental retardation or communication impairment preventing cooperation
Other
- Pregnant patients
- Substance abuse history
- Peripheral neuropathy
Who the study is looking for
- Adults aged 18-72 years
- physical status I-III
- Scheduled for elective surgery
- Body Mass Index (BMI) \> 30 kg/m²
- Provided written informed consent
Age in the registry: 18 years to 72 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| İstinye University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.