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Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.
Sponsor: Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
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.
Official title: Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical Trial.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2026-02-15
Completion Date
2026-09-15
Last Updated
2026-02-13
Healthy Volunteers
Yes
Conditions
Interventions
Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit
A portable, dual-channel TENS unit (TENSCARE Perfect Mama+) delivering low to moderate intensity electrical currents via skin surface electrodes placed on the thoracolumbar region. It has three preset programs, 50-60 intensity levels, a BOOST button for contractions, and an open-circuit safety feature. Used for non-pharmacological labor pain relief.
Sham Comparator
Participants undergo the identical procedure with the TENS unit placed and electrodes attached in the same position, but the device remains switched off (no electrical stimulation is delivered).
Locations (2)
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, Honduras
Instituto Hondureño de Seguridad Social
Tegucigalpa, Francisco Morazán Department, Honduras