RecruitingNot ApplicableNCT07401147

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.

Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical Trial.

Sponsor

Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

Enrollment

132 participants

Start Date

Feb 15, 2026

Study Type

INTERVENTIONAL

Conditions

Labor Pain

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham Comparator and a medical device called Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit for people with labor pain. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous 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.

DEVICESham 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).