Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-08 @ 3:41 PM
Study NCT ID:
NCT06478095
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Visual Aids on Glaucoma Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001296', 'term': 'Audiovisual Aids'}], 'ancestors': [{'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'surgeons were blinded to the patient group assignments.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety levels, pain scores, blood pressure, and pulse rates', 'timeFrame': '1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure', 'description': 'measured at multiple time points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative visit;glaucoma;filtering surgery'], 'conditions': ['Anti-Glaucoma Medications']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery.', 'detailedDescription': 'A randomized, single-blinded, single-centre clinical trial was conducted at a tertiary eye hospital in Shantou, China. Patients scheduled for glaucoma filtration surgery were randomly assigned to either a conventional oral education group or a visual aids group. Anxiety levels, pain scores, blood pressure, and pulse rates were measured at multiple time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult inpatients with age ≥18 years\n* Illiterate or with ≤ 9 years of compulsory education\n* Indications for filtering surgery\n\nExclusion Criteria:\n\n* Mental illness\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT06478095', 'briefTitle': 'Preoperative Visual Aids on Glaucoma Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong'}, 'officialTitle': 'Preoperative Visual Aids on Patients With Low Educational Backgrounds Undergoing Glaucoma Filtration Surgery', 'orgStudyIdInfo': {'id': 'EC 20220505(4)-P30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'The conventional oral education group', 'description': 'Patients were only orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions during the preoperative visit.'}, {'type': 'EXPERIMENTAL', 'label': 'The Visual aids plus conventional oral education group', 'description': 'Patients were orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions with pictures and videos during the preoperative visit.', 'interventionNames': ['Behavioral: Visual aids']}], 'interventions': [{'name': 'Visual aids', 'type': 'BEHAVIORAL', 'description': 'Diagrams, models, and videos', 'armGroupLabels': ['The Visual aids plus conventional oral education group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}], 'overallOfficials': [{'name': 'Chukai Huang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data can be requested and accessed by contacting the study management teams of the studies on reasonable request. Such requests are adjudicated on a case-by-case basis. The study protocol and statistical analysis plan will be available and be accessed once the paper is accepted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shantou University Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr.', 'investigatorFullName': 'Laiwen Lv', 'investigatorAffiliation': 'Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong'}}}}