Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-06 @ 1:48 PM
Study NCT ID:
NCT03689205
Status:
UNKNOWN
Last Update Posted:
2018-09-28
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Obesity on Venous Puncture Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2018-09-27', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': 'one month', 'description': 'pain intensity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Cannulation', 'Body Mass Index']}, 'descriptionModule': {'briefSummary': 'Before surgery, patients will fill the Beck anxiety, distress tolerance test and Pain katastrophizing test. Patients will be divided into two groups according to BMI\\> 30kg / m2 (Group A) and BMI \\<30kg / m2 (Group B). Compared to body weight, venous vascular pain of the groups will be compared.', 'detailedDescription': "Seventy patients will be randomized to two groups(BMI\\> 30kg / m2 (Group A) and BMI \\<30kg / m2 (Group B) during peripheral venous cannulation (PVC). The patients' visual analog scores will be measured during peripheral venous cannulation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'After surgery patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery\n\nExclusion Criteria:\n\n* Patients with a history of anxiety disorders or hearing problem and preoperative pain, emergency surgery'}, 'identificationModule': {'nctId': 'NCT03689205', 'briefTitle': 'The Effect of Obesity on Venous Puncture Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'Assessment of the Effect of Obesity on Venous Puncture Pain', 'orgStudyIdInfo': {'id': '18-KAEK-101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients that BMI> 30kg / m2 (Group A)', 'description': 'Venous puncture pain on patients that Body mass index \\> 30kg / m2'}, {'label': 'Patients that BMI< 30kg / m2 (Group B)', 'description': 'Venous puncture pain on patients that Body mass index \\< 30kg / m2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60200', 'city': 'Tokat Province', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hakan Tapar, Assist.Prof.', 'role': 'CONTACT', 'email': 'hakantapar@hotmail.com', 'phone': '+905056844496'}], 'facility': 'Gaziosmanpasa University', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}], 'centralContacts': [{'name': 'Hakan Tapar', 'role': 'CONTACT', 'email': 'hakantapar@hotmail.com', 'phone': '03562129500', 'phoneExt': '3497'}, {'name': 'Hakan Tapar', 'role': 'CONTACT', 'email': 'akantapar@hotmail.com', 'phone': '03562129500', 'phoneExt': '3497'}], 'overallOfficials': [{'name': 'Hakan Tapar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpasa University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof', 'investigatorFullName': 'Hakan Tapar', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}