Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-04 @ 12:26 AM
Study NCT ID:
NCT07229066
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Video-Based Education on Colonoscopy Preparation
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to either a video-based education group or a control group receiving standard written and verbal instructions. Both groups will be followed in parallel to assess the effect of the intervention on bowel preparation quality before colonoscopy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Bowel Preparation', 'timeFrame': 'Day of Colonoscopy', 'description': 'The quality of bowel preparation will be assessed on the day of colonoscopy using the Boston Bowel Preparation Scale (BBPS). This scale evaluates cleansing in three segments of the colon. Higher scores indicate better preparation, reflecting patient compliance with dietary and laxative instructions and the effectiveness of the educational intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bowel Preparation Quality', 'Colonoscopy', 'Patient Education']}, 'referencesModule': {'references': [{'pmid': '34435269', 'type': 'RESULT', 'citation': 'Walker TB, Hengehold TA, Garza K, Rogers BD, Early D. An Interactive Video Educational Tool Does Not Improve the Quality of Bowel Preparation for Colonoscopy: A Randomized Controlled Study. Dig Dis Sci. 2022 Jun;67(6):2347-2357. doi: 10.1007/s10620-021-07215-8. Epub 2021 Aug 25.'}, {'pmid': '21798022', 'type': 'RESULT', 'citation': 'Chan WK, Saravanan A, Manikam J, Goh KL, Mahadeva S. Appointment waiting times and education level influence the quality of bowel preparation in adult patients undergoing colonoscopy. BMC Gastroenterol. 2011 Jul 28;11:86. doi: 10.1186/1471-230X-11-86.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy is a routine procedure for evaluating gastrointestinal symptoms, detecting colorectal cancer, and removing polyps. Its effectiveness depends on patient compliance with bowel preparation instructions. However, inadequate bowel preparation occurs in 20-25% of colonoscopies, often due to non-adherence, medical conditions, or long waiting times. Poor preparation can reduce examination quality, prevent detection of precancerous lesions, and increase healthcare costs. Video-based education has been shown to be more effective than written or verbal instructions in improving bowel preparation. This study aims to evaluate the effect of video-based education on colonoscopy bowel preparation and contribute evidence to optimize patient compliance.', 'detailedDescription': "Colonoscopy is a standard procedure performed for the evaluation of gastrointestinal symptoms, colorectal cancer screening, polyp detection, and polyp removal. Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States , and in Türkiye, 21,718 new cases were reported in 2022. These statistics underscore the importance of colonoscopy as a preventive and diagnostic tool.\n\nWhen conducted properly, colonoscopy is safe and well-tolerated, allowing visualization of the entire colon and distal terminal ileum. The procedure's optimal effectiveness relies heavily on patient compliance with bowel preparation instructions. Unfortunately, inadequate bowel preparation occurs in approximately 20-25% of colonoscopies, often due to non-adherence, medical conditions affecting bowel cleansing, or prolonged waiting times for the procedure.\n\nWhile interventions addressing medical conditions or waiting times may not always be feasible, non-compliance with preparation instructions represents a modifiable, patient-related factor. Effective bowel preparation requires adherence to dietary recommendations and the use of prescribed laxatives. The quality of preparation impacts examination adequacy, procedure duration, cancellation rates, and the need for repeat colonoscopies. Inadequate preparation can hinder thorough evaluation, prevent detection of precancerous lesions such as polyps, and increase healthcare costs.\n\nEmerging evidence suggests that video-based educational interventions are more effective than traditional written or verbal instructions, phone calls, social media applications, or messaging services in improving patient compliance and bowel preparation quality.\n\nThis study aims to assess the effect of video-based education on bowel preparation before colonoscopy. By evaluating its impact on preparation quality and patient adherence, the study seeks to provide evidence for implementing more effective educational strategies in colonoscopy units, thereby optimizing clinical outcomes and resource utilization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary participation in the study.\n* Outpatient follow-up.\n* No prior history of colonoscopy.\n* Participant or a household member (spouse, child, parent, sibling) owns and can use a smartphone application.\n\nExclusion Criteria:\n\n* History of major abdominal surgery.\n* Suspected obstructive lesion in the gastrointestinal tract on cross-sectional imaging.\n* Impaired swallowing reflex.\n* Mental disorder.\n* Communication difficulties (speech, perception, comprehension problems).\n* Congestive heart failure or kidney failure.\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07229066', 'briefTitle': 'The Effect of Video-Based Education on Colonoscopy Preparation', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'Evaluation of the Effect of Video-Based Education on Bowel Preparation Before Colonoscopy', 'orgStudyIdInfo': {'id': 'ESOGU-OZGENEL-2025-COLONOSCOPY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video-based education group for Sodium Picosulfate (0.1 g) sennoside b (3 mg) + Bisacodyl (5 mg)', 'description': 'Participants receive a video-based education program explaining colonoscopy preparation steps, diet instructions, and use of laxatives.', 'interventionNames': ['Behavioral: Video Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group for Sodium Picosulfate (0.1 g) sennoside B (3 mg) + Bisacodyl (5 mg)', 'description': 'Participants receive routine written and verbal instructions for colonoscopy preparation.'}, {'type': 'EXPERIMENTAL', 'label': 'Video-based education group for Sodium Picosulfate (0.1 g)', 'description': 'Participants receive a video-based education program explaining colonoscopy preparation steps, diet instructions, and use of laxatives.', 'interventionNames': ['Behavioral: Video Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group for Sodium Picosulfate (0.1 g)', 'description': 'Participants receive routine written and verbal instructions for colonoscopy preparation.'}, {'type': 'EXPERIMENTAL', 'label': 'Video-based education group for Sennoside A+B (1875 mg)', 'description': 'Participants receive a video-based education program explaining colonoscopy preparation steps, diet instructions, and use of laxatives.', 'interventionNames': ['Behavioral: Video Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group for Sennoside A+B (1875 mg)', 'description': 'Participants receive routine written and verbal instructions for colonoscopy preparation.'}], 'interventions': [{'name': 'Video Education', 'type': 'BEHAVIORAL', 'description': 'Participants receive routine written and verbal instructions about colonoscopy preparation, including dietary instructions and use of prescribed laxatives. This represents the standard care provided at the study site.', 'armGroupLabels': ['Video-based education group for Sennoside A+B (1875 mg)', 'Video-based education group for Sodium Picosulfate (0.1 g)', 'Video-based education group for Sodium Picosulfate (0.1 g) sennoside b (3 mg) + Bisacodyl (5 mg)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eskişehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Safak Meric Ozgenel, Assistant professor', 'role': 'CONTACT', 'email': 'mozgenel@ogu.edu.tr', 'phone': '+902222392979', 'phoneExt': '2956'}, {'name': 'Fatmanur Ince Ozgenel, PhD', 'role': 'CONTACT', 'email': 'fatmanur_ince@hotmail.com', 'phone': '+902222392979', 'phoneExt': '2950'}], 'facility': 'Eskisehir Osmangazi University', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}], 'centralContacts': [{'name': 'Safak Meric Ozgenel, Assistant professor', 'role': 'CONTACT', 'email': 'mozgenel@ogu.edu.tr', 'phone': '+902222392979', 'phoneExt': '2956'}, {'name': 'Fatmanur Ince Ozgenel, PhD', 'role': 'CONTACT', 'email': 'fatmanur_ince@hotmail.com', 'phone': '+902222392979', 'phoneExt': '2950'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'End date of the study and one year after that', 'ipdSharing': 'YES', 'description': 'All requested data can be shared.', 'accessCriteria': 'The paper reviewers will be able to access the IPD and supporting information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Dr.', 'investigatorFullName': 'Şafak Meric Ozgenel', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}