Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-14 @ 8:37 AM
Study NCT ID:
NCT02220205
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2014-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'snippita@bidmc.harvard.edu', 'phone': '617-667-4165', 'title': 'Siripanth Nippita', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participants directed their own practice time. An investigator answered questions but did not provide other feedback unless specifically asked.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PelvicSim', 'description': 'Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.\n\nPelvicSim', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Manufacturer Model', 'description': 'Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.\n\nManufacturer model', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PelvicSim', 'description': 'Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.\n\nPelvicSim'}, {'id': 'OG001', 'title': 'Manufacturer Model', 'description': 'Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.\n\nManufacturer model'}], 'classes': [{'title': 'Pre-simulation', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '69'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '76'}]}]}, {'title': 'Post-simulation', 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '88'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '91'}]}]}, {'title': 'Three month visit', 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '75'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice', 'description': 'Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.\n\nSets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.', 'unitOfMeasure': 'Percent of tasks performed correctly', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Comfort Placing IUDs From Pre- to Post-insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PelvicSim', 'description': 'Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.\n\nPelvicSim'}, {'id': 'OG001', 'title': 'Manufacturer Model', 'description': 'Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.\n\nManufacturer model'}], 'classes': [{'title': 'Copper IUD', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}, {'value': '96.7', 'groupId': 'OG001'}]}]}, {'title': '52mg levonorgestrel IUD', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': '13.5mg levonorgestrel IUD', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to three months', 'description': 'Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.', 'unitOfMeasure': 'Percent change in comfort', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PelvicSim', 'description': 'Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.\n\nPelvicSim'}, {'id': 'FG001', 'title': 'Manufacturer Model', 'description': 'Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.\n\nManufacturer model'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant voluntarily withdrew from the study due to time constraints which precluded completion of the study visit. Therefore, 60 participants enrolled and were randomized, and 59 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PelvicSim', 'description': 'Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.\n\nPelvicSim'}, {'id': 'BG001', 'title': 'Manufacturer Model', 'description': 'Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.\n\nManufacturer model'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '30'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '30'}, {'value': '27', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Occupation', 'classes': [{'title': 'Intern', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Nurse practitioner student', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Intern or NP student', 'unitOfMeasure': 'participants'}, {'title': 'Prior pelvic exams', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '1-5', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '6-10', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '>10', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'exams'}, {'title': 'Prior IUD insertions performed', 'classes': [{'title': '>=1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '0', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'exams'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2014-08-14', 'resultsFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-21', 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice', 'timeFrame': 'Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice', 'description': 'Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.\n\nSets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Comfort Placing IUDs From Pre- to Post-insertion', 'timeFrame': 'Baseline to three months', 'description': 'Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IUD', 'training', 'simulation'], 'conditions': ['Contraceptive Devices, Intrauterine', 'Education, Medical']}, 'descriptionModule': {'briefSummary': 'Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides.\n\nEducators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-year residents in obstetrics and gynecology or family medicine, or student in physician assistant or nurse practitioner training programs\n* Trainees who have performed \\<5 intrauterine device insertions\n* Trainees who plan to provide intrauterine devices in their clinical practice\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02220205', 'briefTitle': 'Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions', 'orgStudyIdInfo': {'id': '2014P-000106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PelvicSim', 'description': 'Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.', 'interventionNames': ['Other: PelvicSim']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Manufacturer model', 'description': 'Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.', 'interventionNames': ['Device: Manufacturer model']}], 'interventions': [{'name': 'PelvicSim', 'type': 'OTHER', 'armGroupLabels': ['PelvicSim']}, {'name': 'Manufacturer model', 'type': 'DEVICE', 'armGroupLabels': ['Manufacturer model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Siripanth Nippita, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in Obstetrics, Gynecology and Reproductive Biology', 'investigatorFullName': 'Siripanth Nippita', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}