Nctid:
NCT06221917
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M21089", "name"=>"Facies", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>74}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-09", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-04-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Post-test Scores", "timeFrame"=>"1 week after teaching", "description"=>"Post-test Objective Structured Clinical Exam (OSCE) scores Value ranges from 0 to 60. Higher score means better outcome, and vice versa."}], "secondaryOutcomes"=>[{"measure"=>"Numerical Differences of Pre-test and Post-test (Delta)", "timeFrame"=>"1 week after teaching", "description"=>"Numerical differences of Pre- and Post-Objective Structured Clinical Exam (OSCE) scores (Delta) Value ranges from -60 to 60. Higher numerical difference means better outcome, and vice versa."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Teaching method", "Live-streaming", "Face-to-face", "Simple wound suturing"], "conditions"=>["Teaching Method"]}, "referencesModule"=>{"references"=>[{"pmid"=>"33658015", "type"=>"BACKGROUND", "citation"=>"Foo CC, Cheung B, Chu KM. A comparative study regarding distance learning and the conventional face-to-face approach conducted problem-based learning tutorial during the COVID-19 pandemic. BMC Med Educ. 2021 Mar 3;21(1):141. doi: 10.1186/s12909-021-02575-1."}, {"pmid"=>"32675522", "type"=>"BACKGROUND", "citation"=>"McKechnie T, Levin M, Zhou K, Freedman B, Palter VN, Grantcharov TP. Virtual Surgical Training During COVID-19: Operating Room Simulation Platforms Accessible From Home. Ann Surg. 2020 Aug;272(2):e153-e154. doi: 10.1097/SLA.0000000000003999. No abstract available."}, {"pmid"=>"32959688", "type"=>"BACKGROUND", "citation"=>"Doulias T, Gallo G, Rubio-Perez I, Breukink SO, Hahnloser D. Doing More with Less: Surgical Training in the COVID-19 Era. J Invest Surg. 2022 Jan;35(1):171-179. doi: 10.1080/08941939.2020.1824250. Epub 2020 Sep 22."}, {"pmid"=>"33199220", "type"=>"BACKGROUND", "citation"=>"Navia A, Parada L, Urbina G, Vidal C, Morovic CG. Optimizing intraoral surgery video recording for residents' training during the COVID-19 pandemic: Comparison of 3 point of views using a GoPro. J Plast Reconstr Aesthet Surg. 2021 May;74(5):1101-1160. doi: 10.1016/j.bjps.2020.10.068. Epub 2020 Nov 8. No abstract available."}, {"pmid"=>"30849966", "type"=>"BACKGROUND", "citation"=>"Song JSA, McGuire C, Vaculik M, Morzycki A, Plourde M. Cross sectional analysis of student-led surgical societies in fostering medical student interest in Canada. BMC Med Educ. 2019 Mar 8;19(1):77. doi: 10.1186/s12909-019-1502-5."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to assess objectively whether teaching for simple wound sutures via Live-Streaming (LS) using Go-pro® has the same effectiveness as the traditional Face-to-face (FTF) teaching. The main question it aims to answer is whether training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training.\n\nAfter initially doing pre-test, participants will be randomized into two groups: LS and FTF. After teaching exposure, the participants will be given 1 week period of self-training to master the skill (as such procedural skills require a period of self training before we examine the effect of teaching exposure). Afterwards, they underwent post-test again with the previously same examiner, using the same OSCE rubric to avoid bias. Researchers will compare if the LS and FTF groups to see if training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Surgery clerkships\n* Willing to participate voluntarily and give consent to the study\n\nExclusion Criteria:\n\n* Participants who drop out between 1 week period of pre-test and post-test\n* Participants not willing to be involved in the teaching exposure"}, "identificationModule"=>{"nctId"=>"NCT06221917", "acronym"=>"LS vs FTF", "briefTitle"=>"Live-streaming Vs Face-to-face Teaching Method Effectiveness in Training Surgical Clerkship", "organization"=>{"class"=>"OTHER", "fullName"=>"Pelita Harapan University"}, "officialTitle"=>"Objective Assessment of Live-streaming Vs Face-to-face Teaching Method Effectiveness in Training Simple Wound Suturing Skill to Surgical Clerkship", "orgStudyIdInfo"=>{"id"=>"011/K-LKJ/ETIK/I/2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Face-to-face", "description"=>"Face-to-face teaching method", "interventionNames"=>["Other: Face-to-face"]}, {"type"=>"EXPERIMENTAL", "label"=>"Live-streaming", "description"=>"Live-streaming teaching method", "interventionNames"=>["Other: Live-streaming"]}], "interventions"=>[{"name"=>"Face-to-face", "type"=>"OTHER", "description"=>"FTF group are participants who will learn simple sutures physically present with the instructor in the same room.", "armGroupLabels"=>["Face-to-face"]}, {"name"=>"Live-streaming", "type"=>"OTHER", "description"=>"One general surgeon (FH) will teach the participants how to do simple sutures on a mannequin, starting by explaining, then doing a live-demo step-by-step of simple wound suturing. The instructor uses a GoPro Hero 8 device on her head which is connected to the internet and produced live-streaming video, which will then be watched by LS group.", "armGroupLabels"=>["Live-streaming"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"15811", "city"=>"Tangerang", "state"=>"Banten", "status"=>"RECRUITING", "country"=>"Indonesia", "contacts"=>[{"name"=>"Freda Halim, Dr, dr, SpB", "role"=>"CONTACT", "email"=>"freda.halim@uph.edu", "phone"=>"+62812-9900-0530"}, {"name"=>"Freda Halim, Dr, dr, SpB", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Valeska S Candrawinata, dr", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Allen Widysanto, Prof, Dr, dr, SpP", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Andi S Budihardja, Dr, drg, SpBM (K)", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Petra OP Wahjoepramono, dr, SpBS", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Andry Irawan, dr, SpB, Subsp.BD (K)", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Taufik Sudirman, dr, SpB", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Natalia Christina, dr, SpB", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Heru S Koerniawan, dr, SpB", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Jephtah FL Tobing, dr, SpOT (K-Spine)", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Veli Sungono, S. KM, MS", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Mona Marlina, dr", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Eka Wahjoepramono, Prof, Dr, Dr, dr, SpBS, PHD", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Pelita Harapan University", "geoPoint"=>{"lat"=>-6.17806, "lon"=>106.63}}], "centralContacts"=>[{"name"=>"Freda Halim, Dr, dr, SpB", "role"=>"CONTACT", "email"=>"freda.halim@uph.edu", "phone"=>"+62812-9900-0530"}], "overallOfficials"=>[{"name"=>"Freda Halim, Dr, dr, SpB", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Pelita Harapan University"}]}, "ipdSharingStatementModule"=>{"url"=>"https://zenodo.org/", "timeFrame"=>"The data will be available shortly after the study is finished, and will be available publicly for as long as needed.", "ipdSharing"=>"YES", "description"=>"Individual participant data (IPD) will be made publicly available as part of an open access dataset.", "accessCriteria"=>"Open"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pelita Harapan University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Head of Surgery Department, Principal Investigator", "investigatorFullName"=>"Freda Halim", "investigatorAffiliation"=>"Pelita Harapan University"}}}}
