Study of ANSiStim for Pain Relief During Active Labor Phase Through Continues Checking of VAS SCORE
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement
研究概览
简要总结
The specific aim of the study is to do comparison between ANSiStim and Placebo for pain relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative patients with good pain relief .
详细描述
Pain during labor is caused by contractions of the muscles of the uterus and by pressure on the cervix. This pain can be felt as strong cramping in the abdomen, groin, and back, as well as an achy feeling. Some women experience pain in their sides or thighs as well. Most women have an epidural or spinal during labour or after the birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant Women on an Active Labor
排除标准
- •Cardiac Pacemaker or any other implants
- •Psoriasis
- •Diminish mental capacity
研究组 & 干预措施
ANSiStim
The ANSiStim device is designed to administer auricular point stimulation treatment over several days. The advantage of using the ear for this treatment is that it provides numerous points for stimulation within a small area. Stimulation is performed by electrical pulses emitted through strategically positioned needles.
Three zinc air batteries with 1.4 V provide the required stimulation energy for 96 hours. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain. To minimize the risk of adaption or tolerance to the electrical stimulation, it is applied for 3 hours, followed by a pause of 3 hours.
干预措施: ANSiStim (Device)
结局指标
主要结局
Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement
时间窗: 48 Hours
次要结局
未报告次要终点