Nctid:
NCT06221436
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001008", "term"=>"Anxiety Disorders"}], "ancestors"=>[{"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "asFound"=>"Anxiety", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T141", "name"=>"English Lavender", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Herbal and Botanical", "abbrev"=>"HB"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"randomized controlled (experimental and control group)"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>90}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2025-04-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-30", "studyFirstSubmitDate"=>"2024-01-04", "studyFirstSubmitQcDate"=>"2024-01-13", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Vital Signs Observation Form", "timeFrame"=>"First 4 days after surgery", "description"=>"In this form; body temperature value will be evaluated."}, {"measure"=>"Vital Signs Observation Form", "timeFrame"=>"First 4 days after surgery", "description"=>"In this form; respiratory rate will be evaluated."}, {"measure"=>"Vital Signs Observation Form", "timeFrame"=>"First 4 days after surgery", "description"=>"In this form; pulse value will be evaluated"}, {"measure"=>"Vital Signs Observation Form", "timeFrame"=>"First 4 days after surgery", "description"=>"In this form; blood pressure value will be evaluated."}, {"measure"=>"Vital Signs Observation Form", "timeFrame"=>"First 4 days after surgery", "description"=>"In this form; oxygen saturation value will be evaluated."}, {"measure"=>"Vital Signs Observation Form", "timeFrame"=>"First 4 days after surgery", "description"=>"In this form; cerebral oxygen saturation value will be evaluated."}, {"measure"=>"State Anxiety Inventory", "timeFrame"=>"First 4 days after surgery", "description"=>"State Anxiety Inventory measures how the individual expresses himself in a momentary situation. The inventory consists of 20 items in total. In this inventory, each item is on a four-point Likert-type scale consisting of '(1) not at all', '(2) a little', '(3) a lot', '(4) completely' and 1. The total score obtained from the inventory varies between 20-80. High scores from the inventory indicate high anxiety."}], "secondaryOutcomes"=>[{"measure"=>"Cardiac Surgery Symptom Inventory", "timeFrame"=>"Seven days after discharge", "description"=>"The inventory consists of 5 subscales: general, cardiac, trunk, lower and upper extremity symptoms. The inventory is in Likert type and is evaluated between 0-4 as \"Not at all\", \"Very little\", \"Moderate\", \"A lot\", \"Quite a lot\". The score range to be taken from the inventory varies between 0-140. As scores increase, symptom severity also increases."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Vital Signs", "Anxiety State", "Cardiovascular surgery", "Symptom", "Mental imagery"], "conditions"=>["Anxiety State", "Symptoms and Signs", "Vital Signs"]}, "descriptionModule"=>{"briefSummary"=>"This study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery.\n\nThis study was planned to be conducted as a prospective randomized controlled study in the Cardiovascular Surgery service of Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. The universe of the research; It will consist of patients who are hospitalized in the cardiovascular surgery service and who have undergone cardiovascular surgery. The sample will consist of a total of 90 patients hospitalized in the Cardiovascular Surgery service of the same hospital and meeting the inclusion criteria for the study.\n\nPatient Diagnosis Form, Physiological Parameters Monitoring Form, State Anxiety Inventory and Cardiac Surgery Symptom Inventory will be used to collect data. Data will be collected on days 1, 2, 3 and 4 after surgery. In the study, patients will be divided into two groups: intervention (n = 45) and control (n = 45). The intervention group will perform breathing exercises with the olfactory mental imagery technique."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Elective surgery is planned,\n* There is no smell problem,\n* No loss of visual and auditory functions,\n* No previous hospital history,\n* No serious head trauma or nasal injury,\n* No known psychiatric disease or history of anxiolytic drug use,\n* Olfactory, capable of mental imagery\n\nExclusion Criteria:\n\n* Presence of decreased level of consciousness,\n* Having drainage over 200 ml per hour,\n* Ejection fraction less than 30 percent,\n* People with lung disease such as atelectasis and pneumonia,\n* Systolic blood pressure is below 90 mmHg,\n* Patients whose pain control cannot be achieved"}, "identificationModule"=>{"nctId"=>"NCT06221436", "briefTitle"=>"The Effect of Olfactory Mental Imagery and Cardiovascular Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Istanbul Saglik Bilimleri University"}, "officialTitle"=>"The Effect of Olfactory Mental Imagery on Physiological Parameters, Anxiety, and Symptoms After Cardiovascular Surgery", "orgStudyIdInfo"=>{"id"=>"SBUISTANBUL"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Mental Imagery", "description"=>"The Mental Imaging group will receive olfactory mental imagery technique and vagus breathing therapy for 1 hour in the morning and evening on the 1st, 2nd, 3rd and 4th days after surgery. In addition, the standard care (breathing exercises with Triflo, early walking, frequent position changes in bed) and treatment plan, which are the standard protocol of the Cardiovascular Surgery Service, will be continued by the clinic nurse and physician.", "interventionNames"=>["Behavioral: Mental Imagery"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control", "description"=>"The control group was given no intervention other than standard care (breathing exercise with Triflo, early ambulation, frequent position changes in bed) and treatment, which is the standard protocol of the Cardiovascular Surgery Service, by the clinic nurse and physician on the 1st, 2nd, 3rd and 4th days after surgery. Will not be implemented."}], "interventions"=>[{"name"=>"Mental Imagery", "type"=>"BEHAVIORAL", "description"=>"Olfactory mental imagery is the ability to detect an odor in the absence of any odor stimulus.\n\nParticipants will be asked to choose their 4 favorite fragrances from 20 different scents (such as rose, lavender scent) determined by the researcher and proven to have positive effects on mind-body therapy. The determined odors will be visualized by the researcher and picture cards measuring 15X12 cm (for example, a card with a rose picture for the rose smell, etc.) will be created. Participants will visualize the smell by looking at the picture cards, so they will be expected to make their breathing exercises more effective. Vagus breathing technique will be combined with olfactory mental imagery.", "armGroupLabels"=>["Mental Imagery"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Istanbul", "state"=>"Beylikdüzü", "status"=>"RECRUITING", "country"=>"Turkey", "contacts"=>[{"name"=>"Hilal K KARTAL, PhD student", "role"=>"CONTACT", "email"=>"kartal_hilal@yahoo.com", "phone"=>"+0905378870982"}], "facility"=>"Hilal KARTAL", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}], "centralContacts"=>[{"name"=>"Hilal Kartal", "role"=>"CONTACT", "email"=>"kartal_hilal@yahoo.com", "phone"=>"5378870982"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Istanbul Saglik Bilimleri University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Registered Nurse", "investigatorFullName"=>"Hilal KARTAL", "investigatorAffiliation"=>"Istanbul Saglik Bilimleri University"}}}}
