Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT06582550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-03
First Post:
2024-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D052582', 'term': 'Trigger Finger Disorder'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D053682', 'term': 'Tendon Entrapment'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Note that the surgical intervention is the same in both study arms. The comparison is in regards to the post-operative instructions with the aim of quality improvement.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2024-08-29', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction with the operative experience', 'timeFrame': 'within 1 week', 'description': 'Questionnaire to assess patient satisfaction with the operative experience will be distributed within a week in post operative visit'}, {'measure': 'patient instruction recall', 'timeFrame': 'within 1 week', 'description': 'Questionnaire to assess patient instruction recall will be distributed within a week in post operative visit. It consists of 9 questions, the maximum score is 9 and indicates excellent recall.'}, {'measure': 'patient satisfaction with the information given', 'timeFrame': 'within 1 week', 'description': 'Questionnaire to assess patient satisfaction with the information givenwill be distributed within a week in post operative visit\n\nOverall, are you satisfied with the provided post-operative instructions for your hand surgery? Likert-scale 1-10 (with smile face) Overall, were the provided post-operative instructions for your hand surgery easy to understand? Likert-scale 1-10 (with smile face) Overall, did the provided post-operative instructions for your hand surgery had the appropriate amount of information? Likert-scale 1-10 (with smile face)'}, {'measure': 'patient compliance', 'timeFrame': 'within 1 week', 'description': 'Questionnaire to assess patient instruction compliance will be distributed within a week in post operative visit. It consists of 13 questions, each with a score, with 13 being thre maximum patient compliance.'}], 'secondaryOutcomes': [{'measure': 'Nursing staff patient experience', 'timeFrame': 'within 3 months', 'description': "Nursing staff will be asked to present which patients reached out to clinic number/email with questions and if the instrutions decreased the incidence of such\n\nAssessed as binomial outcome\n\nHave you called your surgeon's office post-operatively regarding any unexpected post-operative course? Yes No Unsure"}, {'measure': 'Dash Scores', 'timeFrame': 'within 1 week', 'description': 'Questionnaire to assess patient outcome will be distributed within a week in post operative visit\n\nQuick dash score\n\nQuickDASH DISABILITY/SYMPTOM SCORE= (sum of n responses) - 1 x 25, wherenis equal to the number of completed responses.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome', 'Hand Cyst Ganglion', 'Trigger Finger']}, 'descriptionModule': {'briefSummary': 'The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience.', 'detailedDescription': 'Outcomes of hand surgery are greatly dependent on factors outside the operating theater as well. These include patient compliance to preoperative instructions that consist of proper surgical site care, proper positioning, and following occupational therapy protocols. Previous studies have shown that video-based information provide greater patient satisfaction than verbal instructions. Visual information was also reported to decrease patient anxiety regarding the procedure and increases patient education in terms of procedure risks and benefits(1-5). The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience. The secondary objective is to evaluate if VBI result in better outcomes than standard written instructions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPlease ensure that ALL items below are satisfied to be included in the study.\n\n* Patient undergoing hand and/or upper extremity surgery with Dr. Thibaudeau\n* Patient ≥ 18 years old\n* Patient who comprehends instructions provided in English and/or French\n* Patient who can navigate the internet to complete an online post-operative questionnaire\n\nExclusion Criteria:\n\nPlease ensure that NONE of the following items are selected to be included in the study.\n\n* Patient presenting with intra-articular, open, or pathological fractures\n* Patient presenting with associated tendon or nerve injuries\n* Patient receiving definitive surgery ≥21 days after injury\n* Patient with previous surgeries/deformity in the hand\n* Patient with pre-existing severe joint disease (rheumatoid arthritis, finger joint stiffness, or non-union)\n* Patient with medical contraindications to surgery\n* Patient who is unable to comply with rehabilitation\n* Patient who is unwilling to be followed up\n* Patient with dementia\n* Patient with significant mental illness\n* Patient who is unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06582550', 'briefTitle': 'Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures: a Prospective Controlled Trial', 'orgStudyIdInfo': {'id': '2025-10990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Audiovisual Instruction Group', 'description': 'Patients who require a hand surgery presenting to the clinic will be divided randomly; each participant is assigned by opening a prepared envelope with a dedicated group randomly, if the patient is assigned to group 1, they will receive standard printed instructions regarding their expected postoperative care, but if the patient is assigned to group 2, they will be provided with a barcode to scan to view audiovisual instructions regarding their post-operative course', 'interventionNames': ['Procedure: Minor Hand Procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Written Instruction Group', 'description': 'Patients who require a hand surgery presenting to the clinic will be divided randomly; each participant is assigned by opening a prepared envelope with a dedicated group randomly, if the patient is assigned to group 1, they will receive standard printed instructions regarding their expected postoperative care, but if the patient is assigned to group 2, they will be provided with a barcode to scan to view audiovisual instructions regarding their post-operative course', 'interventionNames': ['Procedure: Minor Hand Procedure']}], 'interventions': [{'name': 'Minor Hand Procedure', 'type': 'PROCEDURE', 'description': 'Unilateral minor hand procedure (carpal tunnel release, trigger finger A1 pulley release, lesion excision)', 'armGroupLabels': ['Audiovisual Instruction Group', 'Written Instruction Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rawan ElAbd, MD MSc', 'role': 'CONTACT', 'email': 'plastic.surgery@muhc.mcgill.ca', 'phone': '514-934-8025'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Plastic Surgery', 'investigatorFullName': 'Stephanie Thibaudeau', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}