Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-13 @ 8:42 AM
Study NCT ID:
NCT03187002
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
Sponsor:
Organization:
Raw JSON
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{'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational Age', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '82'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '82'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'description': 'Measured by ultrasound on day of enrollment and procedure', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-29', 'size': 177602, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-01T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2017-06-09', 'resultsFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-30', 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aspiration Pain', 'timeFrame': 'Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)', 'description': 'Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")'}], 'secondaryOutcomes': [{'measure': 'Speculum Placement Pain', 'timeFrame': 'Intraoperative, collected during procedure (up to 30 seconds)', 'description': 'Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")'}, {'measure': 'Tenaculum Placement Pain', 'timeFrame': 'Intraoperative, collected during procedure (up to 30 seconds)', 'description': 'Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")'}, {'measure': 'Paracervical Block Pain', 'timeFrame': 'Intraoperative, collected during procedure (up to 30 seconds)', 'description': 'Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")'}, {'measure': 'Manual Cervical Dilation Pain', 'timeFrame': 'Intraoperative, collected during procedure (up to 30 seconds)', 'description': 'Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")'}, {'measure': 'Speculum Removal Pain', 'timeFrame': 'Intraoperative, collected during procedure (up to 30 seconds)', 'description': 'Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")'}, {'measure': 'Total Procedure Time', 'timeFrame': 'Intraoperative, collected during procedure (up to 20 minutes)', 'description': 'Time from speculum placement to speculum removal, measured in minutes'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Abortion in First Trimester']}, 'referencesModule': {'references': [{'pmid': '34352845', 'type': 'DERIVED', 'citation': 'Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.'}]}, 'descriptionModule': {'briefSummary': 'High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Presenting for surgical abortion\n* Gestational age \\<12 weeks\n* \\< 18 years of age\n* Agrees to be randomized\n\nExclusion criteria:\n\n* Allergy to study medications (lidocaine, fentanyl, midazolam)\n* \\> 18 years of age\n* Fetal demise\n* Pre-procedure use of misoprostol\n* No means of transportation following procedure'}, 'identificationModule': {'nctId': 'NCT03187002', 'briefTitle': 'Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-41589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous electrical nerve stimulation (TENS)', 'description': 'Transcutaneous electrical nerve stimulation (TENS)', 'interventionNames': ['Device: Transcutaneous electrical nerve stimulation (TENS)', 'Other: SHAM: Moderate IV Sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate IV Sedation', 'description': 'Fentanyl, versed', 'interventionNames': ['Drug: Moderate IV Sedation', 'Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)']}], 'interventions': [{'name': 'Transcutaneous electrical nerve stimulation (TENS)', 'type': 'DEVICE', 'description': 'Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.', 'armGroupLabels': ['Transcutaneous electrical nerve stimulation (TENS)']}, {'name': 'Moderate IV Sedation', 'type': 'DRUG', 'description': 'IV sedation with fentanyl and versed', 'armGroupLabels': ['Moderate IV Sedation']}, {'name': 'SHAM: Transcutaneous electrical nerve stimulation (TENS)', 'type': 'OTHER', 'description': 'Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding', 'armGroupLabels': ['Moderate IV Sedation']}, {'name': 'SHAM: Moderate IV Sedation', 'type': 'OTHER', 'description': 'Sham IV to ensure blinding', 'armGroupLabels': ['Transcutaneous electrical nerve stimulation (TENS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95126', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Planned Parenthood Mar Monte', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'overallOfficials': [{'name': 'Principal Investigator, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}