Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 5:59 PM
Study NCT ID:
NCT01963858
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2013-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Functional Relaxation on Patients Undergoing Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2013-10-12', 'studyFirstSubmitQcDate': '2013-10-12', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'State Trait Anxiety Inventory (STAI)', 'timeFrame': '1 day'}], 'primaryOutcomes': [{'measure': "Patient's abdominal pain during colonoscopy", 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colonoscopy', 'Relaxation']}, 'descriptionModule': {'briefSummary': 'Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is the most common reason for low acceptance of colonoscopy. Several methods have been used to minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to participate in administration of medication. Although a potential benefit from some of these methods has been suggested, no clear recommendations have been made so far. We hypothesized functional relaxation reduces discomfort during colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing screening or surveillance colonoscopy\n\nExclusion Criteria:\n\n* Previous colorectal resection'}, 'identificationModule': {'nctId': 'NCT01963858', 'briefTitle': 'Effect of Functional Relaxation on Patients Undergoing Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Relaxation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional relaxation', 'description': 'Functional relaxation', 'interventionNames': ['Procedure: Functional relaxation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No relaxation', 'description': 'No relaxation', 'interventionNames': ['Procedure: No relaxation']}], 'interventions': [{'name': 'Functional relaxation', 'type': 'PROCEDURE', 'description': 'Functional relaxation during colonoscopy', 'armGroupLabels': ['Functional relaxation']}, {'name': 'No relaxation', 'type': 'PROCEDURE', 'description': 'No relaxation during colonoscopy', 'armGroupLabels': ['No relaxation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403-720', 'city': 'Incheon', 'country': 'South Korea', 'facility': "Incheon St. Mary's hospital, Catholic university of Korea", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': "Uijeongbu St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jeong-Seon Ji', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}