TENS for pain relief during active labor
Official title: Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical Trial.
Run by Universidad Nacional Autonoma de Honduras · NCT07401147 · Data updated 2026-11-12
This trial will try using a TENS device versus a sham to see if it lowers pain for first-time moms during the active phase of labor.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 132 (estimated) |
| Sponsor | Universidad Nacional Autonoma de Honduras Academic / other |
| Locations | 2 sites (Tegucigalpa, Francisco Morazán Department and 1 other locations) |
| Status | Recruiting |
| Started | February 15, 2026 |
| Main results expected | August 31, 2026 |
| Study ends | September 15, 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07401147 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Nulliparous women aged 18–45 with a term (37–42 weeks) singleton cephalic pregnancy in active labor (≥5 cm dilation), with uncomplicated pregnancies and the ability to give informed consent.
✕Probably not a fit
Women with multiple pregnancy, non-cephalic presentation, severe obstetric complications, pre-pregnancy BMI over 30, neurological contraindications to TENS, or abnormal fetal monitoring are not expected to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, two-period crossover trial in nulliparous women at term comparing active transcutaneous electrical nerve stimulation (TENS) with a sham device during the active first stage of labor. Participants are randomized to receive active then sham or sham then active TENS with a standardized 30-minute washout between periods, using a commercial TENSCARE Perfect Mama+ unit with identical-appearing sham devices. The primary outcome is pain intensity measured by the Visual Analog Scale (VAS); secondary outcomes include duration of the active phase, maternal and neonatal safety, and childbirth satisfaction. The trial is conducted in the Labor and Delivery Unit at Hospital Escuela in Tegucigalpa, Honduras from Feb to Aug 2026.
Why it matters
Potential benefit: If successful, TENS could offer a simple, drug-free way to reduce pain during the first stage of labor and potentially lower the need for pharmacologic analgesics.
How similar studies have gone: Previous randomized trials of TENS in labor have produced mixed results, with some showing modest pain reduction and others little effect, so existing evidence is suggestive but not definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, Honduras Recruiting -
Instituto Hondureño de Seguridad Social
Tegucigalpa, Francisco Morazán Department, Honduras Recruiting
Study contacts
- Study coordinator: Ricardo A. Gutierrez Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: +50497546940
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.