Nctid:
NCT06222684
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001008", "term"=>"Anxiety Disorders"}], "ancestors"=>[{"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "relevance"=>"LOW"}, {"id"=>"M4324", "name"=>"Anxiety Disorders", "asFound"=>"Anxiety", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"], "maskingDescription"=>"The evaluation was made by the participants in the study."}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"The study is a randomized controlled trial."}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>74}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2024-04-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-08-20", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-21", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-20", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Anxiety", "timeFrame"=>"20 minutes", "description"=>"Data will be collected using the State Anxiety Inventory. The answer options collected in four classes on the State Anxiety Inventory scale are: (1) Not at all, (2) A little, (3) A lot and (4) Completely; The options on the trait anxiety scale are (1) Rarel, (2) Sometimes, (3) A lot of the time, and (4) Almost always. The higher the score obtained from the scales, the higher the person's anxiety is. The total score obtained from the scale varies between 20-80, and 20-39 indicates a mild anxiety level, 40-59 indicates a medium anxiety level, 60-79 indicates a high anxiety level, and 80 points indicates a panic anxiety level."}, {"measure"=>"Pain Level", "timeFrame"=>"20 minutes", "description"=>"Data will be collected using the Visual Analogue Scale. Pain can be given a score between 0 and 10 on the scale.The higher the scale score, the greater the pain."}], "secondaryOutcomes"=>[{"measure"=>"Satisfaction Level", "timeFrame"=>"20 minutes", "description"=>"Data will be collected using the Visual Analog Scale. Satisfaction can be given a score between 0 and 10 on the scale. The higher the scale score, the higher the satisfaction level."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["mammography", "pain", "music therapy"], "conditions"=>["Breast Cancer", "Pain", "Anxiety"]}, "descriptionModule"=>{"briefSummary"=>"This study was planned to determine the effect of music listened to during mammography screening on pain, anxiety and satisfaction.", "detailedDescription"=>"The randomized controlled and experimental study will be conducted with 70 women who apply to the Cancer Early Diagnosis, Screening and Training Center for mammography screening. Women in the experimental group (n=35) will listen to music before, during and after mammography screening, and women in the control group (n=35) will undergo routine mammography screening. Information Form Containing Sociodemographic Information and Situational Anxiety Inventory will be used to collect data."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"69 years", "minimumAge"=>"40 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Knowing how to read and write,\n* Not having had a mammogram before,\n* Being between the ages of 40-69,\n* No hearing-related problems,\n* Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,\n* Voluntarily participating in the study,\n\nExclusion Criteria:\n\n- The woman has a cognitive and auditory problem"}, "identificationModule"=>{"nctId"=>"NCT06222684", "briefTitle"=>"The Effect of Music on Pain, Anxiety and Satisfaction During Mammography", "organization"=>{"class"=>"OTHER", "fullName"=>"Saglik Bilimleri Universitesi"}, "officialTitle"=>"The Effect of Music on Pain, Anxiety and Satisfaction During Mammography", "orgStudyIdInfo"=>{"id"=>"SumeyyeKose"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention Group", "description"=>"Women in the intervention group applying for mammography screening will listen to music for 5 minutes before, during and after the procedure.", "interventionNames"=>["Other: Music therapy"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control Group", "description"=>"Women in the control group applying for mammography screening will not receive any intervention other than routine mammography screening."}], "interventions"=>[{"name"=>"Music therapy", "type"=>"OTHER", "description"=>"Women applying for mammography screening will receive music therapy for 5 minutes before the procedure, during the mammography scan and for 5 minutes after the procedure.", "armGroupLabels"=>["Intervention Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34890", "city"=>"Istanbul", "state"=>"Pendik", "country"=>"Turkey", "facility"=>"Pendik District Health Directorate Maternal Child Health and Family Planning Center", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Saglik Bilimleri Universitesi", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Phd Student", "investigatorFullName"=>"Sümeyye Köse", "investigatorAffiliation"=>"Saglik Bilimleri Universitesi"}}}}
