Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Labor Pain Intensity
研究概览
简要总结
This is a randomized, double-blind, crossover clinical trial to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapeutic intervention for reducing pain in women during the active phase of labor. Nulliparous women with term pregnancies will be randomly assigned to sequences involving TENS intervention and placebo (device off) periods, separated by a washout. The primary outcome is labor pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include duration of the active labor phase, maternal and neonatal safety profile, and childbirth experience satisfaction. The study will be conducted at the Hospital Escuela Universitario from feb 2026 to Ago 2026.
详细描述
This is a prospective, randomized, double-blind, placebo-controlled, two-sequence, two-period crossover clinical trial. The study aims to evaluate the efficacy and safety of Transcutaneous Electrical Nerve Stimulation (TENS) as a non-pharmacological intervention for pain management during the active phase of first-stage labor.
The trial will be conducted in the Labor and Delivery Unit of the Maternal-Infant Block at Hospital Escuela Universitario in Tegucigalpa, Honduras. The unit is equipped with standard obstetric monitoring and care facilities.
Methodological Details:
Crossover Design: Each participant will act as her own control. Participants will be randomized to one of two sequences: 1) Active TENS followed by Sham TENS, or 2) Sham TENS followed by Active TENS.
Intervention & Control: The active intervention involves the use of a commercial, portable TENS unit (TENSCARE Perfect Mama+). The sham/placebo control involves the identical application of the device and electrodes but with the stimulator unit switched off. To maintain blinding, all devices will be visually identical and pre-coded by a third party not involved in data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The TENS units for active and sham intervention are physically identical. A third party not involved in recruitment, intervention administration, or outcome assessment will pre-code all devices. Participants, the healthcare staff applying the devices, and the research staff assessing the primary outcome (pain via VAS) will be unaware of the device code (active/sham). The randomization list linking codes to sequences will be kept in a password-protected file accessible only to the study statistician until database lock. Blinding success will be formally assessed post-study via participant and staff questionnaires.
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
- •Signed informed consent.
- •Women aged 18-45 years.
- •Nulliparous.
- •Term singleton pregnancy (37-42 weeks).
- •Cephalic presentation.
- •Spontaneous onset of labor or induced/conducted labor under adequate control.
- •Cervical dilation of at least 5 cm at enrollment.
- •Normal amniotic fluid volume and reassuring fetal monitoring.
- •Uncomplicated pregnancy.
排除标准
- •Multiple pregnancy.
- •Non-cephalic presentation.
- •Severe obstetric complications (e.g., preeclampsia, placental abruption).
- •Maternal chronic or acute diseases interfering with safety.
- •History of neurological/psychiatric disorders contraindicating TENS.
- •Abnormal fetal monitoring or amniotic fluid.
- •Pre-pregnancy BMI >30 kg/m².
- •Fetal demise.
- •Illiteracy.
研究组 & 干预措施
Active TENS Intervention
Participants receive transcutaneous electrical nerve stimulation (TENS) using the TENSCARE Perfect Mama+ unit. Electrodes are placed on the thoracolumbar region. The device is used for periods of 30-50 minutes every two hours during the active phase of labor (cervical dilation >=5 cm), or more frequently if desired by the participant.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit (Device)
Sham/Placebo TENS
Participants undergo the same procedure with the TENS unit placed and electrodes attached, but the device remains switched off (no electrical stimulation is delivered)
干预措施: Sham Comparator (Device)
结局指标
主要结局
Labor Pain Intensity
时间窗: Assessed at baseline (upon enrollment at >=5 cm dilation), at 15 minutes, and at 30 minutes after the start of each intervention phase (Active TENS or Sham) during the active phase of labor.
Pain intensity during contractions, measured using the Visual Analog Scale (VAS).
次要结局
- Duration of Active Labor Phase(From study intervention start (>=5 cm) until delivery of the baby (up to 24 hours).)
- Maternal Satisfaction with Childbirth Experience(Assessed once within the first 24 hours postpartum (during the immediate puerperium, before hospital discharge).)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Research Coordinator
Universidad Nacional Autonoma de Honduras