Health Trials

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

ConditionLabor Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorRicardo A Gutierrez Ramirez, MD, MSc, FACOG

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit

    Device

    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

    Device

    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).

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Active TENS InterventionExperimental treatment 1 intervention
Group B: Sham/Placebo TENSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Labor Pain Intensity

Pain intensity during contractions, measured using the Visual Analog Scale (VAS).

Time frame
Assessed at baseline (upon enrollment at >=5 cm dilation), at 15 minutes, and at 30 minutes after the start of each intervention phase (Active TENS or Sham) during the active phase of labor.

Secondary outcomes

1

Duration of Active Labor Phase

Time elapsed from cervical dilation of 5 cm until complete cervical dilation (10 cm).

Time frame
From study intervention start (>=5 cm) until delivery of the baby (up to 24 hours).
2

Maternal Satisfaction with Childbirth Experience

Satisfaction is measured using the validated Mackey Childbirth Satisfaction Rating Scale (MCSRS). This 35-item questionnaire uses a 5-point Likert scale (1 = Very Dissatisfied to 5 = Very Satisfied). The total score ranges from 35 to 175. A baseline score indicating satisfaction is considered to be ≥140 points (corresponding to an average rating of 4 or "Satisfied" across all items). Higher scores represent greater satisfaction with the childbirth experience. The scale assesses multiple dimensions including satisfaction with: the obstetrician, nursing staff, the newborn, the dilation phase, the expulsive phase, and overall comfort.

Time frame
Assessed once within the first 24 hours postpartum (during the immediate puerperium, before hospital discharge).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

Lead sponsor

Universidad Nacional Autonoma de Honduras

Sponsor institution

Source ClinicalTrials.gov
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