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

Inclusion Criteria9

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 Criteria9

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.

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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).