Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00941005
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2009-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'larsonjef@surgery.wisc.edu', 'phone': '(608) 417-6175', 'title': 'Jeffrey Larson, MD', 'organization': 'University of Wisconsin - Madison'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Raw data from which to report summary results no longer exist for this study. Outcomes were published and the data were represented in graphs. We have done our due diligence to populate this record with data provided in the publication.'}}, 'adverseEventsModule': {'timeFrame': 'up to 24 hours post-operatively', 'description': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication. There is no evidence that Adverse Events Data was monitored.', 'eventGroups': [{'id': 'EG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Nausea Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}], 'classes': [{'title': '30 min post-op', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}, {'title': '60 min post-op', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}, {'title': '120 min post-op', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'description': 'Nausea is scored on a scale of 1-10 where 1 is least nauseated and 10 is severely nauseated. Nausea scores will be collected 30, 60, and 120 minutes after surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}, {'type': 'PRIMARY', 'title': 'Incidence of Post-operative Emetic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'incidence of emetic events', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Post-operative Need for Rescue Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}, {'type': 'PRIMARY', 'title': 'Time to Participant Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}, {'type': 'PRIMARY', 'title': 'Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post-op', 'description': 'Phone survey of nausea/vomiting symptoms was administered on postoperative day 1. The survey consists of 8 questions, including: 1) a query about whether or not participant has experienced nausea since returning home; 2) rate nausea severity on a scale of 1-10 (where 10 is the most severe); 3) a query about satisfaction of nausea control; 4) a question asking if they would use the same post-op nausea treatment again; 5) a query about what activities the participant has been unable to do since surgery; 6) whether or not the participant has taken prescription medicine for treatment of nausea since returning home; 7) whether or not participant has taken prescription medicine for treatment of pain since returning home; and 8) if yes for 6-7, which medications.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}], 'classes': [{'title': '30 min post-op', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}, {'title': '60 min post-op', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}, {'title': '120 min post-op', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Participants will evaluate their postoperative pain score on a scale of 1-10 where 1 is the least pain and 10 is the most severe pain. Pain scores will be evaluated at 30, 60, and 120 minutes postop.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Received a device that was not turned on.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data cannot be confirmed', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours post-op', 'description': 'Phone survey of post-op pain medication usage was administered on postoperative day 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device, ReliefBand as well as pharmacologic measures.\n\nElectroacustimulation: Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Sham electroacustimulation device (turned off)\n\nStandardized pharmacologic postoperative nausea and vomiting prevention typical for patients undergoing outpatient surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Data no longer exists', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'data no longer exists', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'data no longer exists', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'data no longer exists', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Data no longer exist for this study', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Data no longer exist for this study', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Data no longer exist for this study', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Data no longer exist for this study', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Raw data no longer exist for this study. We have done our due diligence to populate this record with data provided in the publication.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2009-07-15', 'resultsFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2009-07-16', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-12', 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Nausea Scores', 'timeFrame': '24 hours', 'description': 'Nausea is scored on a scale of 1-10 where 1 is least nauseated and 10 is severely nauseated. Nausea scores will be collected 30, 60, and 120 minutes after surgery.'}, {'measure': 'Incidence of Post-operative Emetic Events', 'timeFrame': '24 hours'}, {'measure': 'Number of Participants With Post-operative Need for Rescue Medications', 'timeFrame': '24 hours'}, {'measure': 'Time to Participant Discharge', 'timeFrame': '24 hours'}, {'measure': 'Phone Survey of Nausea / Vomiting Symptoms 24 Hours Post-op', 'timeFrame': '24 hours post-op', 'description': 'Phone survey of nausea/vomiting symptoms was administered on postoperative day 1. The survey consists of 8 questions, including: 1) a query about whether or not participant has experienced nausea since returning home; 2) rate nausea severity on a scale of 1-10 (where 10 is the most severe); 3) a query about satisfaction of nausea control; 4) a question asking if they would use the same post-op nausea treatment again; 5) a query about what activities the participant has been unable to do since surgery; 6) whether or not the participant has taken prescription medicine for treatment of nausea since returning home; 7) whether or not participant has taken prescription medicine for treatment of pain since returning home; and 8) if yes for 6-7, which medications.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Scores', 'timeFrame': '24 hours', 'description': 'Participants will evaluate their postoperative pain score on a scale of 1-10 where 1 is the least pain and 10 is the most severe pain. Pain scores will be evaluated at 30, 60, and 120 minutes postop.'}, {'measure': 'Number of Participants Who Took Pain Medicine in the First 24 Hours Post-op', 'timeFrame': '24 hours post-op', 'description': 'Phone survey of post-op pain medication usage was administered on postoperative day 1.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '15385352', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Jiao KR, Zenn M, Georgiade G. A randomized controlled comparison of electro-acupoint stimulation or ondansetron versus placebo for the prevention of postoperative nausea and vomiting. Anesth Analg. 2004 Oct;99(4):1070-1075. doi: 10.1213/01.ANE.0000130355.91214.9E.'}, {'pmid': '20195124', 'type': 'RESULT', 'citation': 'Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has been demonstrated to be effective in controlling these symptoms, but trials identifying their efficacy in the outpatient surgery population are lacking. This study integrates conventional pharmacotherapy with alternative medicine in prevention of PONV.\n\nMaterials and Methods: One hundred twenty two patients undergoing surgery procedures at an outpatient surgery center were randomized to two treatment arms. The first arm was standardized pharmacologic PONV prevention typical for patients undergoing outpatient surgery, while the second arm employed the use of ReliefBand, an FDA-approved electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms, emetic events, the need for rescue medications and the time to discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing surgery at the University of Wisconsin outpatient surgery center\n\nExclusion Criteria:\n\n* pregnancy\n* currently experiencing menstrual symptoms\n* cardiac pacemaker\n* previous experience with acupuncture therapy\n* pharmacologic treatment for nausea or vomiting in the 24 hours prior to surgery'}, 'identificationModule': {'nctId': 'NCT00941005', 'briefTitle': 'The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients: A Prospective, Randomized, Blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'H-2007-0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacustimulation', 'description': 'Received electroacustimulation at the wrist using a small, battery-powered electroacustimulation device.', 'interventionNames': ['Device: Electroacustimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Received a device that was not turned on.', 'interventionNames': ['Device: Electroacustimulation']}], 'interventions': [{'name': 'Electroacustimulation', 'type': 'DEVICE', 'otherNames': ['ReliefBand (Aeromedix, Jackson, WY)'], 'description': 'Electroacustimulation (EAS) is a derivative form of acupuncture therapy where a small current of electricity instead of a needle is used to stimulate an acupoint on the human body in an effort to create therapeutic effects.', 'armGroupLabels': ['Control', 'Electroacustimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53719', 'city': 'Middleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Transformations Surgery Center', 'geoPoint': {'lat': 43.09722, 'lon': -89.50429}}], 'overallOfficials': [{'name': 'Karol A Gutowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endeavor Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}