Effects of Oral Contraceptives on Diffuse Noxious Inhibitory Stimulus (DNIC) in Non-painful Healthy Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women
研究概览
简要总结
The purpose of this study is tu assess the influence of oral contraceptives (OC) on diffuse noxious inhibitory control (DNIC) in healthy women, tested during high, low endogenous estrogens sessions and ovulatory period.
详细描述
After being informed about the study and it protocol, all patients giving written informed consent, will undergo to a cephalic (masseter) and extracephalic (finger) mechanical stimulus to evaluate the threshold of mechanical pain, and physiological records of systolic/diastolic pressure and heart rates. After, we will evaluate the threshold response and physiological rates to the same mechanical stimulus under a thermal (cold) conditional pain (TCP) at 3 different moments of menstrual period in No contraceptive group (No OC) versus Contraceptive group (CO). Finally, we will compare the mechanical threshold response, physiological rates and pain perception between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women with oral contraceptive treatment (for at least 3 consecutive months), greater than or equal to 15 years old.
- •Healthy women without oral contraceptive treatment, greater than or equal to 15 years old.
- •Non pregnant women.
- •Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
- •Without systemic pathologies.
排除标准
- •Treatment of a pain, depression, hypertension, convulsion condition with or without medication.
- •Regular use of benzodiazepines.
- •Systemic pathologies
- •Pregnant women
- •Menopausal women
结局指标
主要结局
Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women
时间窗: Baseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual period
The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a mechanical pressure in the masseter (cephalic) and finger (extracephalic) stimulus as the "test stimulus" and a cold-water bath as the "conditioning stimulus". The results of this test will be used as the primary outcome measure.
次要结局
未报告次要终点
研究者
Nicolás Pinto Pardo
DDS, Msc, Ph.D
Universidad Vina del Mar