Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT04595461
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2020-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-operative Patient Anxiety', 'timeFrame': '1 hour preoperatively', 'description': 'Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)'}, {'measure': 'Pre-operative Patient Anxiety', 'timeFrame': '1 hour preoperatively', 'description': 'Visual Analogue Scale (1-10, higher score means higher anxiety)'}], 'secondaryOutcomes': [{'measure': 'Post-operative Anxiety', 'timeFrame': '1 week post-operative', 'description': 'Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)'}, {'measure': 'Post-operative Anxiety', 'timeFrame': '1 week post-operative', 'description': 'Visual Analogue Scale (1-10, higher score means higher anxiety)'}, {'measure': 'Post-operative Pain', 'timeFrame': '1 week post-operative', 'description': 'Measured via Visual Analogue Scale (1-10, higher score means worse pain)'}, {'measure': 'Post-operative Satisfaction', 'timeFrame': '1 week post-operative', 'description': 'Measured via Visual Analogue Scale (1-10, higher score means better satisfaction)'}, {'measure': 'Post-operative medication adherence', 'timeFrame': '1 week post-operative', 'description': 'Measured via frequency of nasal irrigation per day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Rhinosinusitis (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'Chronic rhinosinusitis treatment consists of medical management and surgical intervention. Improving patient education can positively impact perioperative patient experiential outcomes such as anxiety, pain and satisfaction. However, online education materials are often too complex, inaccurate or misleading. The objective of this study was to determine if patient education videos at an appropriate reading level would improve perioperative anxiety in patients undergoing endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* English speaking\n* diagnosed with CRS according to Canadian Guidelines\n* computer or mobile phone access were included\n\nExclusion Criteria:\n\n* immunocompromised\n* had sinonasal tumours\n* history of anxiety, depression, bipolar, or any other mental illnesses'}, 'identificationModule': {'nctId': 'NCT04595461', 'briefTitle': 'Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing', 'orgStudyIdInfo': {'id': 'H17-03567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard of care patient education with verbal and written education', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Video Group', 'description': 'Patient education supplemented with four short youtube videos regarding chronic rhinosinusitis and endoscopic sinus surgery', 'interventionNames': ['Other: Video Education']}], 'interventions': [{'name': 'Video Education', 'type': 'OTHER', 'description': 'Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery', 'armGroupLabels': ['Video Group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Standard patient education with verbal and written education', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Saint Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Andrew Thamboo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Information can be shared with other researchers on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor, Division of Otolaryngology-Head and Neck Surgery', 'investigatorFullName': 'Andrew Thamboo', 'investigatorAffiliation': 'University of British Columbia'}}}}