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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Venous cannulation pain (VAS, 0-10)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-72 years
- •physical status I-III
- •Scheduled for elective surgery
- •Body Mass Index (BMI) > 30 kg/m²
- •Provided written informed consent
排除标准
- •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
研究组 & 干预措施
Cold Application Group
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.
干预措施: Cold Application to Lateral Neck Region (Procedure)
Standard Venous Cannulation Group
Participants will undergo routine peripheral venous cannulation without any prior intervention.
干预措施: Cold Application to Lateral Neck Region (Procedure)
结局指标
主要结局
Venous cannulation pain (VAS, 0-10)
时间窗: 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.
次要结局
未报告次要终点
研究者
İlke Dolgun
Assoc. prof
Istinye University