Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Aspiration Pain
研究概览
简要总结
High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS)
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
Moderate IV Sedation
Fentanyl, versed
干预措施: Moderate IV Sedation (Drug)
结局指标
主要结局
Aspiration Pain
时间窗: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)
Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
次要结局
- Paracervical Block Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Speculum Placement Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Manual Cervical Dilation Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Tenaculum Placement Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Speculum Removal Pain(Intraoperative, collected during procedure (up to 30 seconds))
- Total Procedure Time(Intraoperative, collected during procedure (up to 20 minutes))