An interventional study of Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit and Sham Comparator in Labor Pain, sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG. Recruiting at 2 sites in Honduras. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG · Not applicable, Interventional, and Treatment
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.
This is a prospective, randomized, double-blind, placebo-controlled, two-sequence, two-period crossover clinical trial. The study aims to evaluate the efficacy and safety of Transcutaneous Electrical Nerve Stimulation (TENS) as a non-pharmacological intervention for pain management during the active phase of first-stage labor.
The trial will be conducted in the Labor and Delivery Unit of the Maternal-Infant Block at Hospital Escuela Universitario in Tegucigalpa, Honduras. The unit is equipped with standard obstetric monitoring and care facilities.
Methodological Details:
Crossover Design: Each participant will act as her own control. Participants will be randomized to one of two sequences: 1) Active TENS followed by Sham TENS, or 2) Sham TENS followed by Active TENS.
Intervention \& Control: The active intervention involves the use of a commercial, portable TENS unit (TENSCARE Perfect Mama+). The sham/placebo control involves the identical application of the device and electrodes but with the stimulator unit switched off. To maintain blinding, all devices will be visually identical and pre-coded by a third party not involved in data collection.
Washout Period: A standardized 30-minute washout period will be implemented between the active and sham phases. This duration is based on literature indicating the analgesic effects of TENS subside within 20-60 minutes post-use.
Intervention Periods: Each phase (active or sham) will have a defined application period during cervical dilation from ≥5 cm up to 10 cm. Pain assessments (Visual Analog Scale - VAS) will be conducted at baseline, 15 minutes, and 30 minutes after the initiation of each phase. The total duration of TENS/sham use per phase will be recorded.
Blinding Assessment: At the conclusion of the study, a blinding validation questionnaire will be administered to participants and clinical staff to assess the success of masking.
Additional Assessments: Beyond the crossover phases for pain measurement, the study will continue to observe participants in the experimental group to collect secondary data on the total duration of active labor, mode of delivery, maternal and neonatal complications, and postpartum satisfaction (using the Mackey Satisfaction Childbirth Rating Scale - MCSRS) within 24 hours after birth.
Statistical Considerations: The primary analysis will use linear mixed models or repeated measures ANOVA, accounting for treatment, period, and sequence effects. Carry-over effects will be specifically tested. The intention-to-treat (ITT) and per-protocol (PP) populations will be defined for analysis.
Scientific Rationale: The study design (crossover) increases statistical power and controls for inter-individual variability in pain perception. The double-blind, placebo-controlled approach minimizes bias. The protocol includes specific measures for bias minimization: centralized computerized randomization via REDCap, allocation concealment, and blinded outcome assessment.
Note: The full study protocol contains additional details on sample size calculation (n=132, based on a 1.0-point difference on VAS), safety monitoring, adverse event reporting, data management in REDCap, and ethical oversight by the Institutional Review Board of the Faculty of Medical Sciences, National Autonomous University of Honduras (UNAH).
423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.
This study's planned enrollment of 132 is above the median of 100 across 347 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Ricardo A Gutierrez Ramirez, MD, MSc, FACOG is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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).
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.
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).
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).
Plan to share: Undecided — It is not yet known if there will be a plan to make individual participant data (IPD) available. The final decision will depend on the specific requirements of the target publication journal, further consultation with the local ethics committee regarding data sharing agreements, and a thorough assessment of our capacity to properly anonymize the data while preserving its scientific value for secondary analysis.
Start is estimated for Feb 2026; primary completion for Aug 2026, 6 months later.
Of 191 non-industry interventional studies with no phase under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 6 months is below that.
Counting every sponsor, half of 193 studies reached it within 9 months; a quarter within 5 and three quarters within 14.
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Ricardo A Gutierrez Ramirez, MD, MSc, FACOG