Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor. Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Pain intensity measure
研究概览
简要总结
This study seeks to verify the analgesic efficacy of TENS during the first stage of labor applying TENS parameters that, according to with the evidence, can be effective for this application and discarding the placebo effect according to the methodological recommendations.
详细描述
TENS is a non-pharmacological alternative for pain control during labor. Although it's a method that has been used for decades, there is not enough evidence on its efficacy, so it's considered ineffective in the Spanish and British guidelines of clinical practice. The present study seeks to verify the analgesic efficacy of TENS by applying the electrodes in the spinal nerve roots associated with labor pain and using conventional TENS with parameters that, according to the evidence, may be effective for this application.
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
- Double (Participant, Care Provider)
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
- •Women attending routinary fetal monitoring before labor
排除标准
- •Multiparous
- •Scheduled cesarean
- •Implantable Cardioverter Defibrillator (ICD) or pacemaker
- •Fetal malformation
- •Language barrier
研究组 & 干预措施
Intervention
TENS application using the TensMed S82 (Enraf Nonius). Current parameters: balanced symmetric biphasic square waveform, continuous stimulation, frequency 80 Hz, pulse duration modulated between 250 and 290 μs, modulation time 5 seconds. Self-adhesive electrodes of 50 x 90 mm applied paravertebrally to 2 cm. of the spinous apophysis. Use of two channels with independent intensity (mA): electrodes of the first channel applied at level T10-L1 and second channel ones at level S2-S4. Maximum intensity without reaching pain, increasing the intensity throughout the application to maintain this level. Start of the intervention when the woman expresses pain. End of the intervention when neuraxial anesthesia is applied (if the woman demands it) or after delivery.
干预措施: TENS (Device)
Placebo
Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.
干预措施: TENS Placebo (Device)
结局指标
主要结局
Pain intensity measure
时间窗: Start of intervention, each 30 minutes during intervention, end of intervention (when neuraxial anesthesia is applied -if the woman demands it- or after delivery, assessed up to 10 hours from intervention's start).
Self reported pain intensity. Score 0-10 (0 = no pain, 10 = pain as bad as can be), using a 0-10 pain scale combined with colored faces pain scale, for measuring the change of pain.
次要结局
- TENS satisfaction(At leaving the labor room, assessed up to 3 hours after delivery.)
研究者
Manuel José Sos Gallen
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana