About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent.
Women aged 18-45 years.
Nulliparous.
Term singleton pregnancy (37-42 weeks).
Disqualifiers
Multiple pregnancy.
Non-cephalic presentation.
Severe obstetric complications (e.g., preeclampsia, placental abruption).
Maternal chronic or acute diseases interfering with safety.
Trial design
Treatments tested in this trial
- Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit
- Sham Comparator
Treatment groups
Sponsors and collaborators
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Lead sponsor
Universidad Nacional Autonoma de Honduras
Sponsor institution