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

NCT07401147 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Labor Pain

Interventions

DEVICE

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.

DEVICE

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).

Sponsors & Collaborators

  • Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2026-08-31
Completion
2026-09-15

Countries

  • Honduras

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07401147 on ClinicalTrials.gov