Nctid:
NCT06235996
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000059350", "term"=>"Chronic Pain"}], "ancestors"=>[{"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "relevance"=>"LOW"}, {"id"=>"M29442", "name"=>"Chronic Pain", "asFound"=>"Chronic Pain", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M11014", "name"=>"Lidocaine", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Arrhythmia Agents", "abbrev"=>"AnArAg"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Primary Purpose: Treatment Allocation: Randomized Interventional Model: Parallel Assignment Masking: Not applicable"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2023-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2024-05-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-14", "studyFirstSubmitDate"=>"2024-01-13", "studyFirstSubmitQcDate"=>"2024-01-31", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-15", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-09-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"VAS score", "timeFrame"=>"Immediately before and after an office-based procedure", "description"=>"Visual Analogue Scale (VAS) score"}, {"measure"=>"STAI score", "timeFrame"=>"Immediately before and after an office-based procedure", "description"=>"State-Trait Anxiety Inventory (STAI) score"}, {"measure"=>"Blood pressure", "timeFrame"=>"Immediately before and after an office-based procedure", "description"=>"Systolic and diastolic blood pressure"}, {"measure"=>"Heart rate", "timeFrame"=>"Immediately before and after an office-based procedure", "description"=>"Heart rate"}, {"measure"=>"Biochemical marker of stress", "timeFrame"=>"Immediately before and after an office-based procedure", "description"=>"Salivary cortisol levels"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Chronic pain", "Pain management"], "conditions"=>["Chronic Pain"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine if the use of musical intervention reduces patient anxiety and provides a less painful experience during office-based procedures in a pain management clinic setting.", "detailedDescription"=>"100 patients who are scheduled for interventional procedures will be randomly assigned to either a music intervention group or a no-music group. Such interventional procedures include sacroiliac joint (SI) steroidal injections, SI radiofrequency ablations, peripheral nerve stimulator implantations, caudal and laminar epidural steroidal injections, lumbar medial branch blocks, lumbar medial branch nerve radiofrequency ablations, spinal cord implantation of electro stimulators. These procedures are fluoroscopically guided. Each group will consist of 50 participants. Participants in the music intervention group will listen to their preferred genre of music during their procedure. The study participants in the music intervention group will listen to music via external speakers played in the procedure room. The music will not be loud enough to disrupt the physician's communication with the patient. The no-music group will receive the same treatment throughout the procedure; however, this group will not listen to music at any time during the procedure. To ensure acute pain and anxiety control, participants in both groups will receive standard analgesic treatment in the beginning of their scheduled interventional procedure. Such treatment includes injection and topical application of lidocaine to induce local anesthesia. The patients in both groups will complete a questionnaire that contains VAS and STAI scoring metrics to measure pain and anxiety levels, respectively. This questionnaire will be completed before and immediately after the procedure. Furthermore, we will use salivary cortisol as a non-subjective biomarker of psychological stress in study subjects not undergoing corticosteroid injections. The saliva samples from the study participants will be collected before and after their scheduled office-based procedures. Upon collection of saliva samples from the study participants, the samples will be picked up by the LabCorp, which then will perform salivary cortisol testing; the results will be reported to the study team."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Scheduled office-based procedure\n* Informed consent is signed by a subject\n\nExclusion Criteria:\n\n* Major hearing impairment\n* Sensitivity to music"}, "identificationModule"=>{"nctId"=>"NCT06235996", "briefTitle"=>"Effects of Musical Intervention on Patient Pain and Anxiety for Office-based Procedures", "organization"=>{"class"=>"OTHER", "fullName"=>"Lake Erie College of Osteopathic Medicine"}, "officialTitle"=>"Effects of Musical Intervention on Patient Pain and Anxiety for Office-based Procedures", "orgStudyIdInfo"=>{"id"=>"12345"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Music Intervention", "description"=>"A patient is scheduled for an office-based procedure such as a nerve block, epidural steroid injection, etc. Music-of-choice during the office-based procedure intervention is assigned to this group. Music via external speakers played in the procedure room. To ensure acute pain and anxiety control, participants will receive standard analgesic treatment in the beginning of their scheduled interventional procedure. Such treatment includes injection and topical application of lidocaine to induce local anesthesia. Standard of care is applied.", "interventionNames"=>["Procedure: Office-based procedure indicated for chronic pain with music"]}, {"type"=>"OTHER", "label"=>"Control", "description"=>"A patient is scheduled for an office-based procedure such as a nerve block, epidural steroid injection, etc. No music intervention is assigned to this group. No music at any time during the procedure. To ensure acute pain and anxiety control, participants will receive standard analgesic treatment in the beginning of their scheduled interventional procedure. Such treatment includes injection and topical application of lidocaine to induce local anesthesia. Standard of care is applied.", "interventionNames"=>["Procedure: Office-based procedure indicated for chronic pain without music"]}], "interventions"=>[{"name"=>"Office-based procedure indicated for chronic pain with music", "type"=>"PROCEDURE", "description"=>"Such procedure may include sacroiliac joint (SI) steroidal injections, SI radiofrequency ablations, peripheral nerve stimulator implantations, caudal and laminar epidural steroidal injections, lumbar medial branch blocks, lumbar medial branch nerve radiofrequency ablations, spinal cord implantation of electro stimulators.", "armGroupLabels"=>["Music Intervention"]}, {"name"=>"Office-based procedure indicated for chronic pain without music", "type"=>"PROCEDURE", "description"=>"Office-based procedure indicated for chronic pain without music", "armGroupLabels"=>["Control"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33544", "city"=>"Wesley Chapel", "state"=>"Florida", "country"=>"United States", "facility"=>"NeuSpine Institute", "geoPoint"=>{"lat"=>28.23973, "lon"=>-82.32787}}, {"zip"=>"33540", "city"=>"Zephyrhills", "state"=>"Florida", "country"=>"United States", "facility"=>"NeuSpine Institute", "geoPoint"=>{"lat"=>28.23362, "lon"=>-82.18119}}], "overallOfficials"=>[{"name"=>"Kamal Patel, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"NeuSpine Institute, Florida"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Lake Erie College of Osteopathic Medicine", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Rebecca Steiner, Ph.D.", "investigatorAffiliation"=>"Lake Erie College of Osteopathic Medicine"}}}}
