[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623785":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":78,"collaborators":26,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Universidad Nacional Autonoma de Honduras","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Transcutaneous Electrical Nerve Stimulation (TENS); TENSCARE Perfect Mama+ TENS unit",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham\u002FPlacebo 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)",[19],"Device: Sham Comparator",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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).",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ricardo A. Gutierrez Ramirez, MD, MSc","CONTACT","+50497546940","ricardo.gutierrez@unah.edu.hn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Sara J. Sevilla Ardon, MD","504 99706157","docencia.investigacion2012@gmail.com",[42,63],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hospital Escuela","RECRUITING","Tegucigalpa","Francisco Morazán Department","11101","Honduras","HN",{"type":51,"coordinates":52},"Point",[53,54],-87.20681,14.0818,{"lat":54,"lon":53},[57,60],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":36},"Ricardo Arturo Gutierrez Ramirez, MD, MSc.","50497546940",{"name":61,"role":34,"phone":62,"phoneExt":26,"email":40},"Sara J Sevilla Ardon, MD","50499706157",{"facility":64,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Instituto Hondureño de Seguridad Social",{"type":51,"coordinates":66},[53,54],{"lat":54,"lon":53},[69,70,73,75,76],{"name":61,"role":34,"phone":62,"phoneExt":26,"email":40},{"name":71,"role":72,"phone":26,"phoneExt":26,"email":26},"Cristhian O Sandoval Alfaro, MD","PRINCIPAL_INVESTIGATOR",{"name":74,"role":72,"phone":26,"phoneExt":26,"email":26},"Jorge L Turcios Varela, MD",{"name":61,"role":72,"phone":26,"phoneExt":26,"email":26},{"name":77,"role":72,"phone":26,"phoneExt":26,"email":26},"Maynor E Rodriguez Burgos, MD",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Ricardo A Gutierrez Ramirez, MD, MSc, FACOG","Research Coordinator","100623785","transcutaneous-electrical-nerve-stimulation-tens-for-pain-management-during-labor-100623785",false,"NCT07401147","Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management During Labor.","Transcutaneous Electrical Stimulation for Pain Reduction During Labor: A Crossover Clinical Trial.","TENS-LABOR","Inclusion Criteria:\n\n* Signed informed consent.\n* Women aged 18-45 years.\n* Nulliparous.\n* Term singleton pregnancy (37-42 weeks).\n* Cephalic presentation.\n* Spontaneous onset of labor or induced\u002Fconducted labor under adequate control.\n* Cervical dilation of at least 5 cm at enrollment.\n* Normal amniotic fluid volume and reassuring fetal monitoring.\n* Uncomplicated pregnancy.\n\nExclusion Criteria:\n\n* Multiple pregnancy.\n* Non-cephalic presentation.\n* Severe obstetric complications (e.g., preeclampsia, placental abruption).\n* Maternal chronic or acute diseases interfering with safety.\n* History of neurological\u002Fpsychiatric disorders contraindicating TENS.\n* Abnormal fetal monitoring or amniotic fluid.\n* Pre-pregnancy BMI \\>30 kg\u002Fm².\n* Fetal demise.\n* Illiteracy.",true,"FEMALE","18 Years","45 Years",{"count":95,"type":96},132,"ESTIMATED","INTERVENTIONAL",[99],"NA","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.",[102],"Labor Pain",[104,105,106,107,108],"labor pain","Transcutaneous Electric Nerve Stimulation","Analgesia","Pain Management","Natural Childbirth","2026-02-10",{"date":111,"type":112},"2026-02-13","ACTUAL",{"date":114,"type":96},"2026-02-15",{"date":116,"type":96},"2026-09-15",{"name":80,"class":6},2]