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

NCT07401147 | Recruiting DMC

• 1 other identifier: PGO-UNAH-49-3-2026
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

labor pain; Transcutaneous Electric Nerve Stimulation; Analgesia; Pain Management; Natural Childbirth

Outcome Measures

Primary Outcomes (1)

• Labor Pain Intensity

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

  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 (2)

• Duration of Active Labor Phase

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

• Maternal Satisfaction with Childbirth Experience

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

Study Arms (2)

Active TENS Intervention

EXPERIMENTAL

Participants receive transcutaneous electrical nerve stimulation (TENS) using the TENSCARE Perfect Mama+ unit. Electrodes are placed on the thoracolumbar region. The device is used for periods of 30-50 minutes every two hours during the active phase of labor (cervical dilation \>=5 cm), or more frequently if desired by the participant.

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

Sham/Placebo TENS

SHAM COMPARATOR

Participants undergo the same procedure with the TENS unit placed and electrodes attached, but the device remains switched off (no electrical stimulation is delivered)

Device: Sham Comparator

Interventions

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).

Sham/Placebo TENS

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.

Active TENS Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: only pregnant womens are eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ricardo A Gutierrez Ramirez, MD, MSc, FACOG: lead

Study Sites (2)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Instituto Hondureño de Seguridad Social

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Related Publications (1)

• Ge Z, He J, Zhang P, Zhao W, Zhu G, Zhang J, Song Z, Cui J, Jiang X, Yu W. Clinical Outcomes and Radiologic Parameters of Endoscopic Lumbar Interbody Fusion Using a Novel Nerve Baffle with a Minimum 1-year Follow-up. World Neurosurg. 2023 Aug;176:e181-e189. doi: 10.1016/j.wneu.2023.05.025. Epub 2023 May 12.

  PMID: 37178917 BACKGROUND

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Ricardo A. Gutierrez Ramirez, MD, MSc

CONTACT

+50497546940; ricardo.gutierrez@unah.edu.hn

Sara J. Sevilla Ardon, MD

CONTACT

504 99706157; docencia.investigacion2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The TENS units for active and sham intervention are physically identical. A third party not involved in recruitment, intervention administration, or outcome assessment will pre-code all devices. Participants, the healthcare staff applying the devices, and the research staff assessing the primary outcome (pain via VAS) will be unaware of the device code (active/sham). The randomization list linking codes to sequences will be kept in a password-protected file accessible only to the study statistician until database lock. Blinding success will be formally assessed post-study via participant and staff questionnaires.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Randomized, double-blind, two-sequence (A-B, B-A), two-period crossover design. Sequence A: Active TENS first, then placebo. Sequence B: Placebo first, then active TENS. A 30-minute washout period between phases.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

HO (2)