Nctid:
NCT06228365
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014689", "term"=>"Venous Insufficiency"}], "ancestors"=>[{"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M17435", "name"=>"Venous Insufficiency", "asFound"=>"Venous Insufficiency", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.\n\nMaximum duration of patient participation in the study = 2 days."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>400}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-12", "completionDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2023-12-14", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pain intensity assessed by NRS (numerical rating scale)", "timeFrame"=>"Day 1", "description"=>"The intensity of maximum pain during the surgery will be assessed by numerical rating scale (NRS) graduated from 0 (no pain) to 10 (worst pain imaginable)."}], "secondaryOutcomes"=>[{"measure"=>"Level of pre-operative anxiety assessed by the patient using the STAI-Y", "timeFrame"=>"Day 0", "description"=>"The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory)."}, {"measure"=>"Level of post-operative anxiety assessed by the patient using the STAI-Y", "timeFrame"=>"Day 1", "description"=>"The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory)."}, {"measure"=>"treatment administered during the procedure", "timeFrame"=>"Day 1", "description"=>"Nature and quantities of additional sedative treatment administered during the procedure"}, {"measure"=>"Pain intensity assessed by NRS (numerical rating scale)", "timeFrame"=>"Day 1", "description"=>"Pain intensity assessed by NRS (numerical rating scale)"}, {"measure"=>"Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale)", "timeFrame"=>"Day 0", "description"=>"Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied)."}, {"measure"=>"Overall patient satisfaction day 1 assessed by NRS (numerical rating scale)", "timeFrame"=>"Day 1", "description"=>"Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied)."}, {"measure"=>"Surgery duration", "timeFrame"=>"Day 0", "description"=>"Assessment of the surgery duration"}, {"measure"=>"Length of stay in the ICU", "timeFrame"=>"Day 1", "description"=>"Length of stay in the ICU"}, {"measure"=>"Length of stay in the hospital", "timeFrame"=>"Day 1", "description"=>"Length of stay in the hospital"}, {"measure"=>"Resumption of current activities", "timeFrame"=>"Day 1", "description"=>"Resumption of current activities measured by: YES or NO"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Superficial Venous Insufficiency"]}, "descriptionModule"=>{"briefSummary"=>"Virtual reality has been shown to reduce the pain experienced during medical procedures.\n\nThe aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.", "detailedDescription"=>"The main objective of the study is to test the non-inferiority of the effect of sedation by the virtual reality device on the intensity of maximum intraoperative pain compared with the usual neuroleptanalgesic treatment, tolerating a margin of non-inferiority of 0.5 points.Pain will be assessed on an ENS immediately at the end of the surgical procedure.\n\nProspective, randomised, open-label, single-centre study in two parallel groups of 200 patients.\n\nMaximum duration of patient participation in the study = 2 days."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour).\n* Outpatients with superficial venous insufficiency for which a surgical indication has been given\n* Patient requiring sedation associated with local anesthesia\n\nExclusion Criteria:\n\n* Contraindication to local anesthesia or any of the sedatives used in the protocol\n* Hearing or visual impairment contraindicating use of the virtual reality headset\n* Pregnant or breast-feeding patients\n* Unbalanced epilepsy\n* Patients under court protection, guardianship or curatorship\n* Patients not affiliated to the French social security system\n* Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient"}, "identificationModule"=>{"nctId"=>"NCT06228365", "acronym"=>"CIMES", "briefTitle"=>"Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation", "organization"=>{"class"=>"OTHER", "fullName"=>"GCS Ramsay Santé pour l'Enseignement et la Recherche"}, "officialTitle"=>"Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency", "orgStudyIdInfo"=>{"id"=>"2023-A01948-37"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"usual neuroleptanalgesic treatment", "description"=>"- Group 1: local anaesthesia by tumescence + neuroleptanalgesia", "interventionNames"=>["Drug: Neuroleptanalgesia"]}, {"type"=>"EXPERIMENTAL", "label"=>"use of a device incorporating virtual reality software", "description"=>"- Group 2: local anaesthesia by tumescence with virtual reality software", "interventionNames"=>["Device: use of a device incorporating virtual reality software"]}], "interventions"=>[{"name"=>"use of a device incorporating virtual reality software", "type"=>"DEVICE", "description"=>"use of a device incorporating virtual reality software", "armGroupLabels"=>["use of a device incorporating virtual reality software"]}, {"name"=>"Neuroleptanalgesia", "type"=>"DRUG", "description"=>"Usual neuroleptanalgesic treatment", "armGroupLabels"=>["usual neuroleptanalgesic treatment"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"31240", "city"=>"Saint-Jean", "status"=>"RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Lauranne MATRAY, MD", "role"=>"CONTACT", "email"=>"dr.lmatray.union@gmail.com", "phone"=>"05 61 37 81 81", "phoneExt"=>"33"}], "facility"=>"Clinique de l'Union", "geoPoint"=>{"lat"=>43.6642, "lon"=>1.49941}}], "centralContacts"=>[{"name"=>"Lauranne MATRAY, MD", "role"=>"CONTACT", "email"=>"dr.lmatray.union@gmail.com", "phone"=>"05 61 37 81 81", "phoneExt"=>"33"}], "overallOfficials"=>[{"name"=>"Lauranne MATRAY, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Clinique de l'Union"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"GCS Ramsay Santé pour l'Enseignement et la Recherche", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Vivactis M2Research", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
