Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT03279666
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2017-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biopsy Size and Pain Perception During Colposcopic Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' Biopsy Sizes", 'timeFrame': '6 months', 'description': "Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size."}, {'measure': "Patients' Biopsy Sizes", 'timeFrame': '6 months', 'description': "Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size."}], 'secondaryOutcomes': [{'measure': "Patients' pain perceptions", 'timeFrame': '6 months analgesic', 'description': "Are patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception."}, {'measure': "Patients' pain perceptions", 'timeFrame': '6 months', 'description': "Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Uterus', 'Tenaculum']}, 'referencesModule': {'references': [{'pmid': '32550738', 'type': 'DERIVED', 'citation': 'Comba C, Demirayak G, Erdogan SV, Karaca I, Demir O, Guler O, Ozdemir IA. Comparison of pain and proper sample status according to usage of tenaculum and analgesia: a randomized clinical trial. Obstet Gynecol Sci. 2020 Jul;63(4):506-513. doi: 10.5468/ogs.19185. Epub 2020 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.', 'detailedDescription': 'The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 year-old women who had colposcopic biopsy\n\nExclusion Criteria:\n\n* Had orthopedical problems\n* Analgesic allergy\n* Have previous cone biopsy\n* Analgesic use until six hours before colposcopy\n* Advanced cervicovaginal atrophy\n* Linear Visual Analog Score for pain is used'}, 'identificationModule': {'nctId': 'NCT03279666', 'briefTitle': 'Biopsy Size and Pain Perception During Colposcopic Biopsy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': "A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy", 'orgStudyIdInfo': {'id': '2017/47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tenaculum with intracervical blockage', 'interventionNames': ['Other: Tenaculum replacement']}, {'type': 'NO_INTERVENTION', 'label': 'No tenaculum with intracercical blockage'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tenaculum without intracervical blockage', 'interventionNames': ['Other: Tenaculum replacement']}, {'type': 'NO_INTERVENTION', 'label': 'No Tenaculum without intracervical blockage'}], 'interventions': [{'name': 'Tenaculum replacement', 'type': 'OTHER', 'description': 'Tenaculum replacement during colposcopic biopsy', 'armGroupLabels': ['Tenaculum without intracervical blockage', 'tenaculum with intracervical blockage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Cihan Comba', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}