Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 11:42 AM
Study NCT ID:
NCT01600495
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2011-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dralemar@uol.com.br', 'phone': 'Tel.: (16) 36022587', 'title': 'Prof. Alessandra Cristina Marcolin', 'phoneExt': '55 +', 'organization': 'University of São Paulo.'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'There were no observed adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Classification of Pain During Labor by Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '72.1', 'spread': '15.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.\n\nVisual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We evaluated 46 patients, divided into 23 ENT group and 23 in the control group.'}, {'type': 'SECONDARY', 'title': 'Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 hours', 'description': 'Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzing the date of application of pharmacological analgesia.'}, {'type': 'SECONDARY', 'title': 'Duration From Start of Labor Until Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '393', 'spread': '139.4', 'groupId': 'OG000'}, {'value': '322', 'spread': '75.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 hours', 'description': 'The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.', 'unitOfMeasure': 'min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzing the duration of labor'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "Fisher's exact test", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10 hours', 'description': 'Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients were invited to answer the questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'We start with the prediction of collecting 20 patients in the treated group', 'groupId': 'FG000', 'numSubjects': '23'}, {'comment': 'We start with the prediction of collecting 20 control patients', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'We finished the job with 23 patients for each group (treated and control)', 'groupId': 'FG000', 'numSubjects': '23'}, {'comment': 'We finished the job with 23 patients for each group (treated and control)', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "A randomized, controlled clinical noninferiority with an evaluator blind, comparative analysis of a study group and a control group, this estdo includes 46 patients, was developed in the Reference Center for Women's Health in Ribeirão Preto, São Paulo state Brazil, during the period September 2011 to February 2012 .", 'preAssignmentDetails': '283 women in labor were eligible, women were excluded because they did not participate 237 the inclusion criteria (first pregnancy, the position of a single fetus head, above 37 weeks, 4-5 cm of cervical dilatation, spontaneous onset of labor, not use of medications during the study period, intact membranes, and not associated with risk factors).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '19.8', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-18', 'studyFirstSubmitDate': '2011-09-19', 'resultsFirstSubmitDate': '2012-05-16', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-02', 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classification of Pain During Labor by Visual Analogue Scale', 'timeFrame': '30 minutes', 'description': 'To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.\n\nVisual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia', 'timeFrame': '10 hours', 'description': 'Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.'}, {'measure': 'Duration From Start of Labor Until Birth', 'timeFrame': '10 hours', 'description': 'The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.'}, {'measure': 'Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.', 'timeFrame': '10 hours', 'description': 'Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain', 'electric stimulation', 'nervous', 'transcutaneous', 'humanized childbirth'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '26701166', 'type': 'DERIVED', 'citation': 'Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC. Transcutaneous electrical nerve stimulation (TENS) reduces pain and postpones the need for pharmacological analgesia during labour: a randomised trial. J Physiother. 2016 Jan;62(1):29-34. doi: 10.1016/j.jphys.2015.11.002. Epub 2015 Dec 11.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/11129512', 'label': 'VAN DER SPANK, J.T.; CAMBIER, D.C.; DE PAEPE, H.M.C.; DANNEELS, L.A.G.; WITVROUW, E.E.; BEERENS, L. Pain relief in labour by transcutaneous electrical nerve stimulation (TENS). Arch Gynecol Obstet, v.264, p.131-136 May 2000.'}]}, 'descriptionModule': {'briefSummary': "The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction.", 'detailedDescription': "Pain in the work appears as a subjective experience of interaction, involving a wide individual influences physiological, psychosocial and environmental factors, representing a major clinical signs of this phase. Despite presenting an important biological function, is now well established the need for their relief, since its persistence is associated with detrimental effects for both mother and fetus. Among non-pharmacological resources available, the investigators highlight the massage therapy that has shown positive effects in relieving pain and promote comfort of the mother. The objective of this research is to evaluate the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (lumbosacral massage) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p \\<0.05 for statistical significance of 5%."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primigravida\n* literate\n* A single fetus in vertex position\n* Low-risk Pregnancy\n* From 37 weeks of gestation\n* Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage\n* Labor in early spontaneous\n* No use of medications during the study period\n* Absence of cognitive or psychiatric problems\n* Intact membranes\n* No risk factors associated\n* Who wish to participate and signed the informed consent\n\nExclusion Criteria:\n\n* TENS procedure intolerance\n* Use of any medication or procedure that promotes pain relief\n* Use of pacemaker'}, 'identificationModule': {'nctId': 'NCT01600495', 'briefTitle': 'Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Transcutaneous Nerve Electrical Stimulation for Pain Relief in Nulliparous Women in Active Phase of Labor', 'orgStudyIdInfo': {'id': 'FR259137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental TENS', 'description': 'TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm', 'interventionNames': ['Other: Experimental TENS']}, {'type': 'NO_INTERVENTION', 'label': 'control Group', 'description': 'Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.'}], 'interventions': [{'name': 'Experimental TENS', 'type': 'OTHER', 'description': 'Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).', 'armGroupLabels': ['Experimental TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'centro de referência para a saúde da mulher Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Alessandra C Marcolin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine of São Paulo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof Dra.', 'investigatorFullName': 'Alessandra Cristina Marcolin', 'investigatorAffiliation': 'University of Sao Paulo'}}}}