Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-03 @ 6:46 PM
Study NCT ID:
NCT02484105
Status:
UNKNOWN
Last Update Posted:
2015-09-29
First Post:
2015-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'on average 20 minutes after completed colonoscopy.', 'description': 'Questionnaire with 5 point Likert like scale'}], 'secondaryOutcomes': [{'measure': 'Per-procedural Pain management', 'timeFrame': 'From inclusion to completed procedure. On average 45 minutes from first to last measurement.', 'description': 'Pain/discomfort prior to-, every 5. minutes and post-procedure with patients using the Visual Analogue Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.', 'detailedDescription': 'Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management. A randomized controlled trial on comforting conversation or standard communication during colonoscopy. Using a mixed methods model, a qualitative study will be conducted to clarify what patients deem as important or effective conversation during colonoscopy. A randomized controlled trial will hereafter be conducted, where the results from the initial study will be utilized in the conversation during colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-85\n* Colonoscopy\n* Written informed content\n\nExclusion Criteria:\n\n* ASA Class 4 or higher\n* BMI 40 or higher\n* Analgesics taken prior to procedure\n* Pregnancy or breast feeding\n* Allergy to Fentanyl/Midazolam\n* Daily consumption of opioids\n* Unable to complete questionnaire'}, 'identificationModule': {'nctId': 'NCT02484105', 'acronym': 'ComConEndo', 'briefTitle': 'Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Comforting Conversation During Colonoscopy: A Randomised Controlled Trial on Patient Satisfaction', 'orgStudyIdInfo': {'id': 'H-15001924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comforting Conversation', 'description': 'Conversation according to the initital qualitative study.', 'interventionNames': ['Behavioral: Comforting Conversation', 'Behavioral: Standard Communication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Communication', 'description': 'Standard information prior to and during endoscopy.', 'interventionNames': ['Behavioral: Standard Communication']}], 'interventions': [{'name': 'Comforting Conversation', 'type': 'BEHAVIORAL', 'description': 'Pain management, distraction, diversion, empathy. Dependent on qualitative study results.', 'armGroupLabels': ['Comforting Conversation']}, {'name': 'Standard Communication', 'type': 'BEHAVIORAL', 'description': 'Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.', 'armGroupLabels': ['Comforting Conversation', 'Standard Communication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'state': 'Region H', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jakob Hendel, MD', 'role': 'CONTACT', 'email': 'Jakob.Hendel@regionh.dk'}, {'name': 'Jeppe Thue Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Endoscopy, Gastrounit, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Peter Vilmann, MD', 'role': 'CONTACT', 'email': 'Peter.Vilmann@regionh.dk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeppe Thue Jensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jeppe Thue Jensen', 'investigatorAffiliation': 'Copenhagen University Hospital at Herlev'}}}}