Labor PainTENS-LABORNCT07401147
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.
A study testing Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit in people with Labor Pain, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 2 sites in Honduras.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesHonduras
- Study dates
- 15 Feb 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- Cervical dilation of at least 5 cm at enrollment.
- Normal amniotic fluid volume and reassuring fetal monitoring.
- Uncomplicated pregnancy.
Who cannot join
- 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.
Show all 9Show fewer
- Pre-pregnancy BMI >30 kg/m².
- Fetal demise.
- Illiteracy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras2 sites, 2 recruiting
- Recruiting
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
Ricardo Arturo Gutierrez Ramirez, MD, MSc., 50497546940, ricardo.gutierrez@unah.edu.hn
Sara J Sevilla Ardon, MD, 50499706157, docencia.investigacion2012@gmail.com
- Recruiting
Instituto Hondureño de Seguridad Social
Tegucigalpa, Francisco Morazán Department, 11101
Sara J Sevilla Ardon, MD, 50499706157, docencia.investigacion2012@gmail.com
Cristhian O Sandoval Alfaro, MD
About this study
Official title: Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical 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.
Read the detailed description
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).
- Conditions
- Labor Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit, Sham Comparator
- Keywords
- labor pain, Transcutaneous Electric Nerve Stimulation, Analgesia, Pain Management, Natural Childbirth
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unitDevice
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 ComparatorDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Pain Intensity
Pain intensity during contractions, measured using the Visual Analog Scale (VAS).
Measured: 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
Time elapsed from cervical dilation of 5 cm until complete cervical dilation (10 cm).
Measured: 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.
Measured: Assessed once within the first 24 hours postpartum (during the immediate puerperium, before hospital discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401147
- Sponsor's protocol ID
- PGO-UNAH-49-3-2026
- Acronym
- TENS-LABOR
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37178917
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT07401147
- Acronym / sponsor ID
- TENS-LABOR / PGO-UNAH-49-3-2026
- Conditions
- Labor Pain
- Keywords
- labor pain, Transcutaneous Electric Nerve Stimulation, Analgesia, Pain Management, Natural Childbirth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOGUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active TENS Intervention | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unitParticipants 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. |
| Sham/Placebo TENS | Sham comparator | Device: Sham ComparatorParticipants undergo the same procedure with the TENS unit placed and electrodes attached, but the device remains switched off (no electrical stimulation is delivered) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed informed consent.
- Women aged 18-45 years.
- Nulliparous.
- Term singleton pregnancy (37-42 weeks).
- Cephalic presentation.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unitA 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 | Active TENS Intervention |
| Sham ComparatorParticipants 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). | Device | Sham/Placebo TENS |
Primary outcome
Labor Pain Intensity
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.
Pain intensity during contractions, measured using the Visual Analog Scale (VAS).
2 secondary outcomes
Duration of Active Labor Phase
Time frame: From study intervention start (>=5 cm) until delivery of the baby (up to 24 hours).
Maternal Satisfaction with Childbirth Experience
Time frame: Assessed once within the first 24 hours postpartum (during the immediate puerperium, before hospital discharge).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 37178917Ge 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.
- Individual participant dataSharing planned: 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.
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit in people with Labor Pain, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 2 sites in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A. Gutierrez Ramirez, MD, MSc (+50497546940, ricardo.gutierrez@unah.edu.hn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor Pain Intensity (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.