Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor. (NCT07401147) | Clinical Trial Compass
RecruitingNot Applicable
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.
Honduras132 participantsStarted 2026-02-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Labor Pain Intensity
Timeframe: 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.
Trial details
NCT IDNCT07401147
SponsorRicardo A Gutierrez Ramirez, MD, MSc, FACOG