[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628426":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":31,"overallOfficials":17,"centralContacts":17,"locations":17,"responsibleParty":40,"collaborators":17,"id":44,"slug":17,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":17,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":17,"enrollmentInfo":52,"targetDuration":17,"studyType":55,"phases":17,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":68,"whyStopped":17,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":17},{"fullName":5,"class":6},"Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Informed Consent Comprehension Score","The Anesthesia Preoperative Information and Informed Consent Comprehension Questionnaire is used to assess patients' understanding of the anesthesia informed consent process. The questionnaire includes 20 objective knowledge questions related to anesthesia procedures, risks, and patient rights. Each correct answer receives 1 point, while incorrect or \"I do not know\" responses receive 0 points. The total score ranges from 0 to 20, with higher scores indicating better understanding of the informed consent information.","30 minutes after completion of the informed consent information session",[14],{"measure":15,"description":16,"timeFrame":12},"Anesthesia Awareness Score","1. Anesthesia Knowledge Score Measured using the Anesthesia Preoperative Information and Informed Consent Comprehension Questionnaire knowledge section. The score ranges from 0 to 20, with higher scores indicating greater knowledge about anesthesia procedures and perioperative care.\n2. Anesthesia Risk Awareness Score Assessed using questionnaire items related to awareness of common and rare anesthesia-related risks. Scores range from 0 to 10, with higher scores indicating greater awareness of anesthesia-related risks.\n3. Perceived Adequacy of Information Score Measured using Likert-scale items evaluating patient perception of the adequacy and clarity of the information provided. The total score ranges from 10 to 50, with higher scores indicating greater perceived adequacy of the information provided during the consent process.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":6,"timePerspective":19,"maskingInfo":17},"PROSPECTIVE","Informed consent is a fundamental ethical and legal component of anesthesia practice. However, previous literature has demonstrated that patients frequently have limited understanding of anesthesia procedures, associated risks, and their rights within the consent process. Written informed consent forms are often complex and may exceed recommended readability levels, potentially reducing comprehension.\n\nThis study is designed as a prospective, cluster-randomized controlled trial conducted in an anesthesia outpatient clinic. The objective is to evaluate whether supplementing standard written informed consent with structured visual support material improves patients' comprehension of the consent process and their level of anesthesia awareness.\n\nPatients presenting to the anesthesia outpatient clinic for preoperative evaluation will be allocated in clusters of ten to one of two study arms:\n\nControl Group: Standard written informed consent form.\n\nIntervention Group: Standard written informed consent form supplemented with structured visual support material designed to present anesthesia-related information in simplified and visually supported format.\n\nAll patients will receive standardized verbal information delivered by the same anesthesiologist to minimize variability in explanation. The visual support material was developed based on current anesthesia guidelines and health communication principles.\n\nTo reduce assessment bias, outcome evaluation will be performed by a second anesthesiologist who is blinded to group allocation. Thirty minutes after completion of the information session, patients will complete a structured questionnaire assessing:\n\nComprehension of informed consent\n\nAwareness of anesthesia procedures\n\nAwareness of anesthesia-related risks and complications\n\nThe primary outcome measure is the difference between groups in informed consent comprehension scores. Secondary outcomes include differences in anesthesia awareness and risk recognition scores.\n\nThe study aims to provide evidence on whether visually supported communication strategies can enhance patient-centered informed consent processes in anesthesia practice.","The study population consists of adult patients presenting to the anesthesia outpatient clinic for routine preoperative evaluation prior to elective surgical procedures requiring anesthesia. Participants will be recruited consecutively during the preoperative assessment period.\n\nThe study includes patients who are able to read and understand Turkish and who are capable of providing informed consent. Patients undergoing emergency surgery, individuals with known cognitive impairment, and those unable to complete the questionnaire will be excluded.\n\nThis population represents typical preoperative anesthesia outpatients in a tertiary care hospital setting.",[23,27],{"label":24,"type":17,"description":17,"interventionNames":25},"Standard Informed Consent Group",[26],"Other: Standard Informed Consent",{"label":28,"type":17,"description":17,"interventionNames":29},"Visual support group",[30],"Other: Visual Support Supplemented Informed Consent",[32,36],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":17},"Standard Informed Consent","Participants in this arm will receive the standard written informed consent form routinely used in the anesthesia outpatient clinic. In addition, standardized verbal information about anesthesia procedures, risks, and perioperative processes will be provided by the same anesthesiologist.",[24],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":17},"Visual Support Supplemented Informed Consent","Participants in this arm will receive the standard written informed consent form supplemented with structured visual support material designed to enhance comprehension of anesthesia procedures, risks, and patient rights. Standardized verbal information will also be provided by the same anesthesiologist.",[28],{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","SULTAN KONUK","Asistant Doctor","100628426",false,"NCT07461480","Effect of Visual Aids Added to Informed Consent on Patient Understanding and Anesthesia Awareness","The Effect of Visual Aids Used in Addition to the Informed Consent Form on Understanding of Consent and Level of Anesthesia Awareness in Patients Attending the Anesthesia Outpatient Clinic","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients presenting to the anesthesia outpatient clinic for preoperative -evaluation\n* Scheduled for elective surgery requiring anesthesia\n* Able to read and understand Turkish\n* Able to provide informed consent\n* Willing to participate in the study\n\nExclusion Criteria:\n\n* Age under 18 years\n* Emergency surgery cases\n* Known cognitive impairment or diagnosed psychiatric disorder affecting comprehension\n* Visual or hearing impairment preventing adequate communication Illiteracy\n* Previous participation in this study\n* Refusal to participate","ALL","18 Months",{"count":53,"type":54},236,"ESTIMATED","OBSERVATIONAL","This prospective cluster-randomized controlled study aims to evaluate whether visual support material provided in addition to the standard written informed consent form improves patients' comprehension of informed consent and their level of anesthesia awareness in an anesthesia outpatient clinic setting.\n\nPatients presenting to the anesthesia outpatient clinic will be allocated in clusters to receive either standard written informed consent alone or standard consent supplemented with structured visual support material. All patients will receive standardized verbal information delivered by the same anesthesiologist.\n\nThirty minutes after the information session, comprehension of informed consent and anesthesia awareness levels will be assessed using a structured questionnaire administered in a standardized manner by a blinded anesthesiologist.\n\nThe primary objective is to determine whether visual support enhances patient understanding of informed consent. Secondary objectives include evaluating its effect on anesthesia-related risk awareness and overall anesthesia knowledge.",[58,59],"Anesthesia","Surgical Patients",[61,62,63,64,65,66,67],"Informed Consent","Visual Support","Health Communication","Cluster Randomized Trial","Anesthesia Outpatient Clinic","Risk Awareness","Patient Education","NOT_YET_RECRUITING","2026-03-13",{"date":71,"type":72},"2026-03-17","ACTUAL",{"date":74,"type":54},"2026-03",{"date":76,"type":54},"2026-11",{"name":5,"class":6}]