Nctid:
NCT06617728
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010591", "term"=>"Phantom Limb"}], "ancestors"=>[{"id"=>"D000010468", "term"=>"Perceptual Disorders"}, {"id"=>"D000019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000010149", "term"=>"Pain, Postoperative"}, {"id"=>"D000011183", "term"=>"Postoperative Complications"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000010146", "term"=>"Pain"}], "browseLeaves"=>[{"id"=>"M13498", "name"=>"Phantom Limb", "asFound"=>"Phantom Limb", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M13379", "name"=>"Perceptual Disorders", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M13069", "name"=>"Pain, Postoperative", "relevance"=>"LOW"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"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"=>39}, "targetDuration"=>"12 Months", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-02-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-05-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-26", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Prevalence of phantom limb pain", "timeFrame"=>"1 week, 3 months, 6 months, and 12 months", "description"=>"The percentage of amputee patients reporting PLP at each follow-up interval. PLP will be categorized as mild, moderate, or severe based on VAS scores."}, {"measure"=>"o Prevalence of phantom limb sensations", "timeFrame"=>"1 week, 3 months, 6 months, and 12 months", "description"=>"The frequency of non-painful PLS such as tingling, itching, or movement sensations reported by patients at each follow-up period"}], "secondaryOutcomes"=>[{"measure"=>"Incidence of residual limb pain", "timeFrame"=>"1 week, 3 months, 6 months, and 12 months", "description"=>"The number of patients reporting RLP at each follow-up interval, categorized based on VAS scores."}, {"measure"=>"o Impact of Analgesic Methods", "timeFrame"=>"1 week, 3 months, 6 months, and 12 months", "description"=>"The effect of different analgesic methods on the prevalence and severity of PLP and PLS. Outcomes will be analyzed to determine which analgesic method is associated with lower pain scores and fewer phantom sensations."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Phantom Limb Pain", "Amputation", "Earthquake Injuries", "Türkiye Earthquake 2023"], "conditions"=>["Phantom Limb Pain", "Amputation", "Pain Management", "Earthquake"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to investigate the prevalence and persistence of phantom limb pain (PLP) among amputees who experienced limb loss due to injuries sustained during the 2023 Türkiye earthquake. The main questions it aims to answer are:\n\nWhat is the prevalence of phantom limb pain among earthquake-related amputees at different follow-up intervals? How do different pain management strategies, such as regional analgesia versus intravenous analgesia, affect the severity and persistence of phantom limb pain? Researchers will compare participants receiving regional analgesia to those receiving intravenous analgesia to see if regional techniques are associated with lower rates of phantom limb pain and improved quality of life.\n\nParticipants will:\n\nComplete pain assessments using standardized questionnaires at 1 week, 3 months, 6 months, and 12 months post-amputation.\n\nProvide information on their pain management experiences and the impact on their daily activities.", "detailedDescription"=>"This observational study aims to assess the prevalence, characteristics, and management of phantom limb pain (PLP) among individuals who underwent amputations due to injuries sustained during the 2023 Türkiye earthquake. Conducted at the Mersin University Pain Clinic, the study involves 39 patients who were followed for 12 months post-amputation. The primary focus is to evaluate how different analgesic methods, such as regional versus intravenous analgesia, influence the development and persistence of PLP and associated phantom limb sensations (PLS).\n\nPatients were recruited from those treated at Mersin University Hospital immediately following the earthquake. Inclusion criteria included individuals aged 5 years and older who experienced amputation due to earthquake-related trauma. Exclusion criteria included pre-existing psychiatric disorders, history of neuropathic pain in the amputated limb, or inability to communicate due to cognitive impairment.\n\nThe study's primary outcomes are the prevalence of PLP and PLS at 1 week, 3 months, 6 months, and 12 months post-amputation. Pain intensity is measured using the Visual Analog Scale (VAS), and the impact of different analgesic techniques on pain severity and quality of life is analyzed. Secondary outcomes include the incidence of residual limb pain and the effectiveness of various pain management strategies in reducing pain symptoms over time.\n\nThis study is expected to contribute valuable insights into the management of PLP in disaster-related amputees, providing evidence to guide clinical practice and improve patient outcomes in similar post-disaster settings."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"5 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"The study population consists of individuals who underwent amputations due to injuries sustained during the 2023 Türkiye earthquake. These patients were treated at the Pain Clinic of Mersin University Hospital and include both males and females aged 5 years and older. The study focuses on patients experiencing phantom limb pain (PLP) following amputation and evaluates the impact of different pain management strategies on their pain outcomes and quality of life. Participants include a diverse group with varying levels of amputation and injury severity, providing a comprehensive understanding of PLP in a post-disaster context.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Individuals aged 5 years and older.\n* Patients who have undergone amputation due to injuries sustained during the 2023 Türkiye earthquake.\n* Experiencing phantom limb pain (PLP) as confirmed by a structured questionnaire.\n* Able to provide informed consent or have consent provided by a legal guardian if under the age of 18.\n\nExclusion Criteria:\n\n* Pre-existing psychiatric disorders that could interfere with pain perception or reporting.\n* History of neuropathic pain in the amputated limb prior to the earthquake.\n* Underwent surgical interventions in other parts of the body that may affect pain assessment.\n* Inability to communicate effectively due to cognitive impairment or other medical conditions."}, "identificationModule"=>{"nctId"=>"NCT06617728", "briefTitle"=>"Phantom Limb Pain in Amputees After the 2023 Türkiye Earthquake", "organization"=>{"class"=>"OTHER", "fullName"=>"Mersin University"}, "officialTitle"=>"Beyond the Quake: Exploring the Persistence of Phantom Limb Pain in Amputees from the 2023 Türkiye Earthquake", "orgStudyIdInfo"=>{"id"=>"TURK-PLP-2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Group 1: Regional Analgesia Cohort", "description"=>"Participants receiving regional analgesia for pain management.", "interventionNames"=>["Procedure: Intervention 1: Regional Analgesia"]}, {"label"=>"Group 2: Intravenous (IV) Analgesia Cohort", "description"=>"Participants receiving IV analgesia for pain management.", "interventionNames"=>["Drug: Intervention 2: Intravenous (IV) Analgesia"]}], "interventions"=>[{"name"=>"Intervention 1: Regional Analgesia", "type"=>"PROCEDURE", "description"=>"Regional analgesia techniques like epidural or peripheral nerve blocks.", "armGroupLabels"=>["Group 1: Regional Analgesia Cohort"]}, {"name"=>"Intervention 2: Intravenous (IV) Analgesia", "type"=>"DRUG", "description"=>"IV medications used for pain control, including opioids and non-opioid analgesics.", "armGroupLabels"=>["Group 2: Intravenous (IV) Analgesia Cohort"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33133", "city"=>"Mersin", "state"=>"Yenişehir", "country"=>"Turkey", "facility"=>"Mersin University Faculty of Medicine", "geoPoint"=>{"lat"=>36.79526, "lon"=>34.61792}}], "overallOfficials"=>[{"name"=>"Mesut Bakır, Assoc. Prof", "role"=>"STUDY_CHAIR", "affiliation"=>"Mersin University Faculty of Medicine, Pain Clinic"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "CSR"], "timeFrame"=>"Data will be available starting six months after publication of the primary results and for a period of five years.", "ipdSharing"=>"YES", "description"=>"De-identified participant data will be shared upon reasonable request. Data will include demographic information, clinical outcomes, and responses to pain assessments. Researchers can request access by contacting the Principal Investigator at \\[mesutbakir@gmail.com\\]. Data will be available starting six months after publication of the primary results and for a period of five years.", "accessCriteria"=>"De-identified participant data will be shared upon reasonable request. Data will include demographic information, clinical outcomes, and responses to pain assessments. Researchers can request access by contacting the Principal Investigator at \\[mesutbakir@gmail.com\\]."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Mesut Bakır", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Clinical Professor", "investigatorFullName"=>"Mesut Bakır", "investigatorAffiliation"=>"Mersin University"}}}}
