Nctid:
NCT06617611
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000777", "term"=>"Anesthetics"}], "ancestors"=>[{"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "asFound"=>"Acid", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>792}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-06-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Agreement between degree of worry and surgical fear", "timeFrame"=>"2024", "description"=>"Measure of agreement using Cohen's kappa"}, {"measure"=>"What matters to you", "timeFrame"=>"2025", "description"=>"A thematic analysis of the answers to the question what matters to you"}, {"measure"=>"Integration of the qualitative and quantitative data", "timeFrame"=>"2025", "description"=>"Mixed methods analysis"}], "primaryOutcomes"=>[{"measure"=>"Degree of worry", "timeFrame"=>"June 2024", "description"=>"How worried are patients on the day of surgery on a scale from 1-10"}], "secondaryOutcomes"=>[{"measure"=>"Surgical fear", "timeFrame"=>"June 2024", "description"=>"How fearful are patients based on an 8-item scale with total score ranging from 0-80"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Surgical Fear and Worrying", "Person-centered Care"]}, "descriptionModule"=>{"briefSummary"=>"Research show that between 48-97% of patients referred to surgery experience anxiety and fear related to the procedure. High levels of anxiety and fear lead to increased use of anesthetics and pain as well as increased morbidity after the surgical procedure.\n\nJune 6 2024 is the international \"What matters to you-day\" and thus we mark this day in several Danish hospitals by asking patients referred to surgery: \"What matters to you on the day of surgery\"? This observational study has three goals:\n\n1. To explore what matters to patients on the day of surgery\n2. To explore associations between patients' degree-of-worry and their surgical fear on the day of surgery\n3. To explore the characteristics and intensity of degree-of-worry\n\nFrom 7.00 AM to 11.00 PM patients will be invited to answer:\n\n1. What matters to them on the day of surgery and why it matters\n2. How worried they are about their situation using a scale from 1 to 10, and to state why they worry.\n3. Eight questions about their fear related to anesthesia and surgery on a scale from 0-10\n\nIn the analysis we will investigate the possible association between patients' degree of worry and fear related to anesthesia and surgery. Secondly, we analyse the prevalence of degree of worry and fear according to gender, age, type of surgery and medical speciality.\n\nFinally, we will investigate what themes appear when we analyse the answers to what matters and why patients' worry."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Danish speaking adults referred to any type of planned surgery on June 6 2024", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Danish speaking\n* 18 years old or above\n\nExclusion Criteria:\n\n* Patients who are not cognitively intact\n* Do not consent to participation\n* Patients requiring immediate surgical intervention."}, "identificationModule"=>{"nctId"=>"NCT06617611", "acronym"=>"WMTY2024", "briefTitle"=>"What Matters to You on the Day of Surgery 2024?", "organization"=>{"class"=>"OTHER", "fullName"=>"Gødstrup Hospital"}, "officialTitle"=>"What Matters to You on the Day of Surgery 2024?", "orgStudyIdInfo"=>{"id"=>"1-16-02-118-24"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Surgical intervention and anesthesia", "type"=>"PROCEDURE", "description"=>"Any surgical procedure"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Herning", "country"=>"Denmark", "facility"=>"Gødstrup Hospital", "geoPoint"=>{"lat"=>56.13932, "lon"=>8.97378}}], "overallOfficials"=>[{"name"=>"Hejdi Gamst-Jensen, SR", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Rigshospitalet, Denmark"}, {"name"=>"Anne H Nielsen, Ass. prof.", "role"=>"STUDY_CHAIR", "affiliation"=>"Gødstrup Hospital"}, {"name"=>"Lone Brix, Lecturer", "role"=>"STUDY_DIRECTOR", "affiliation"=>"University of Aarhus"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gødstrup Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Rigshospitalet, Denmark", "class"=>"OTHER"}, {"name"=>"University of Aarhus", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Postdoc", "investigatorFullName"=>"Brigitta Rasmussen Villumsen", "investigatorAffiliation"=>"Gødstrup Hospital"}}}}
