[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659010":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":49,"studyPopulation":38,"armGroups":50,"interventions":68,"overallOfficials":82,"centralContacts":87,"locations":92,"responsibleParty":126,"collaborators":129,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":136,"sex":142,"minAge":143,"maxAge":38,"enrollmentInfo":144,"targetDuration":38,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":95,"whyStopped":38,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Aydin Adnan Menderes University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Post-consent knowledge score","Score on a 10-item multiple-choice test derived from the consent text (range 0-10; higher scores indicate better knowledge of the procedure, its risks, alternatives and patient responsibilities). Each item is mapped to a specific paragraph of the consent form. Analyzed as a continuous variable.","Day of consent, immediately after completion of the consent process (before surgery)",[14,18,21,24,27,31,34],{"measure":15,"description":16,"timeFrame":17},"Post-consent state anxiety (STAI-S)","State-Trait Anxiety Inventory, State form (Turkish version, Öner \\& Le Compte), range 20-80; higher scores indicate greater anxiety. Measured immediately after the consent process and analyzed adjusted for the pre-consent STAI-S score (measured immediately before the consent process) and STAI-T.","Day of consent, immediately after the consent process",{"measure":19,"description":20,"timeFrame":17},"Patient satisfaction and perceived clarity","Three study-specific 5-point items (perceived clarity of the information, adequacy of the information for decision-making, overall satisfaction with the consent process); each scored 1-5, higher scores indicate better outcomes. Reported item by item; total score (3-15) secondary. Not validated.",{"measure":22,"description":23,"timeFrame":17},"Perceived naturalness and usefulness of the audio recording (arms B and C)","Two study-specific 5-point items: naturalness of the voice (1 = not at all natural to 5 = completely natural) and usefulness of receiving the information as audio (1 = not at all to 5 = very much). Higher scores indicate greater perceived naturalness\u002Fusefulness. Asked in both audio arms.",{"measure":25,"description":26,"timeFrame":17},"Acceptability of the AI-generated voice (arm C)","Single study-specific 5-point item: \"Did it bother you that the voice was generated by artificial intelligence?\" (1 = not at all to 5 = very much; higher scores indicate lower acceptability). Administered on a separate sheet after the naturalness items have been collected.",{"measure":28,"description":29,"timeFrame":30},"Number of audio replays (arms B and C)","Number of times the patient chose to replay the audio recording.","Day of consent (during the consent session)",{"measure":32,"description":33,"timeFrame":17},"Self-reported reading of the written consent form","Single item with four categories: read all of it \u002F read most of it \u002F skimmed it \u002F did not read it.",{"measure":35,"description":36,"timeFrame":37},"Withdrawal from or postponement of the planned procedure","Number and percentage of patients who decline or postpone the planned surgery after the consent process, and of patients who stop the audio recording before completion. Reported descriptively by arm; not interpreted as an adverse outcome.","From the consent process to the scheduled date of surgery (up to 7 days)",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Three-arm parallel-group randomized trial with 1:1:1 allocation, stratified by center and education level. Arms B and C receive the standard written consent process plus an audio recording of the identical consent text.","HEALTH_SERVICES_RESEARCH",{"masking":45,"maskingDescription":46,"whoMasked":47},"SINGLE","Participants and staff delivering the intervention cannot be blinded. The knowledge test is scored by an assessor blinded to allocation, and the statistician receives the dataset with masked arm labels until the primary analysis is completed.",[48],"OUTCOMES_ASSESSOR","Design: multicenter, prospective, parallel-group, three-arm (1:1:1) randomized controlled trial with outcome-assessor and analyst blinding.\n\nStimuli: The same unified URS\u002FRIRS consent text is used in all arms. Arm B uses a single studio recording read by one urologist (identical at all centers; not the patients' own surgeon). Arm C uses a voice clone of the same urologist generated with Resemble.ai from a separate reference recording (≥5 min, different text), rendered once and frozen (no live AI calls). Both recordings were loudness-matched (-24.0 LUFS), mono, 48 kHz, AAC; duration 716.8 s vs 708.4 s (1.2% difference). Recordings are presented after the standard written consent process and physician explanation are completed, on a tablet with headphones; patients may replay them (replay count recorded) and may ask the physician questions in every arm. Arms B and C are introduced with structurally parallel sentences (\"read by a urologist\" vs \"generated with AI from a urologist's voice\").\n\nRandomization: computer-generated, stratified by center (3) and education level (middle school or less \u002F high school or higher), 6 strata, permuted blocks of varying size (block sizes not disclosed to site staff); allocation concealment by sequentially numbered, sealed, opaque envelopes; the person opening envelopes differs from the outcome scorer. Knowledge tests are scored by an assessor blinded to arm; the dataset is transferred to the statistician with masked arm labels.\n\nHypotheses (fixed-sequence testing, two-sided α=0.05): H1 knowledge score arm C \\> arm A; H2 arm B \\> arm A (tested only if H1 is significant); H3 arm C vs arm B - descriptive only, adjusted mean difference with 95% CI compared against a pre-specified reference range of ±1.0 point; no equivalence or non-inferiority claim will be made.\n\nSample size: to detect a 1.0-point difference (SD 2.0, d=0.50) with 85% power, 72 analyzable patients per arm; 80 per arm (240 total) allowing 10% loss. A blinded sample-size re-estimation (pooled SD, arm labels not revealed) is performed once after 120 patients; if pooled SD \\>2.3 the sample size is recalculated with the same effect, α and power.\n\nAnalysis: ANCOVA for post-consent knowledge score with arm, education, procedure, age and center; secondary ANCOVA for post-consent STAI-S (STAI-S2) adjusted for pre-consent STAI-S (STAI-S1), STAI-T, sex, education, procedure and center. Pre-specified supportive analysis: arm A vs pooled audio arms (B+C). Exploratory: education × arm interaction; physician (consenting doctor) variance. Knowledge-test psychometrics (KR-20, item difficulty, discrimination) are reported from trial data. Reporting follows CONSORT.\n\nAnalysis set: the primary analysis is performed in the modified intention-to-treat (mITT) population - all randomized patients analyzed in their allocated arm who have a measured primary outcome. If missing primary outcome data exceed 5%, a sensitivity analysis using multiple imputation is performed; a per-protocol analysis is also reported as sensitivity analysis.",[51,57,63],{"label":52,"type":53,"description":54,"interventionNames":55},"A: Written consent (standard care)","ACTIVE_COMPARATOR","Standard care: the unified written consent form plus the physician's usual verbal explanation. No audio recording.",[56],"Other: Standard written informed consent",{"label":58,"type":59,"description":60,"interventionNames":61},"B: Written consent + urologist-read audio","EXPERIMENTAL","Standard care plus an audio recording of the entire consent text read by a urologist (the same recording at all centers), presented after the standard consent process.",[56,62],"Behavioral: Human-voice audio consent recording",{"label":64,"type":59,"description":65,"interventionNames":66},"C: Written consent + AI-cloned voice audio","Standard care plus an audio recording of the same text generated with AI from a voice clone of the same urologist, presented after the standard consent process; patients are told that the voice was generated with AI.",[56,67],"Behavioral: AI-cloned-voice audio consent recording",[69,73,78],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":38},"Standard written informed consent","The institution's unified written informed consent form for ureteroscopy and retrograde intrarenal surgery, read and signed by the patient, together with the physician's usual verbal explanation. Delivered identically in all three arms.",[52,58,64],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":38},"BEHAVIORAL","Human-voice audio consent recording","An approximately 12-minute audio recording of the complete consent text, read word for word by one urologist (the same recording at all centers; not the patient's own surgeon). Presented after the standard written consent and physician explanation, on a tablet with headphones in the patient's room without companions; the patient may replay it and the number of replays is recorded. Loudness-normalized to -24 LUFS. Introduced to the patient as \"a recording of the entire consent form read by a urologist\".",[58],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":38},"AI-cloned-voice audio consent recording","The same consent text, generated once with Resemble.ai from a voice clone of the same urologist (reference sample: a separate recording of at least 5 minutes of a different text), frozen before enrollment with no live AI calls. Duration approximately 12 minutes; loudness-matched (-24 LUFS), codec and delivery identical to the human-voice recording, presented after the standard written consent and physician explanation, on a tablet with headphones; replay allowed and counted. Patients are informed that the voice was generated with AI from a urologist's voice.",[64],[83],{"name":84,"affiliation":85,"role":86},"Ahmet Emre Yildiz, MD","Aydin City Hospital","PRINCIPAL_INVESTIGATOR",[88],{"name":84,"role":89,"phone":90,"phoneExt":38,"email":91},"CONTACT","+90 535 312 98 32","aemreyildiz@gmail.com",[93,108,115],{"facility":94,"status":95,"city":96,"state":97,"zip":38,"country":98,"countryCode":38,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Aydin Adnan Menderes University, Department of Urology","RECRUITING","Aydin","Aydın","Turkey (Türkiye)",{"type":100,"coordinates":101},"Point",[102,103],27.83963,37.84501,{"lat":103,"lon":102},[106],{"name":107,"role":86,"phone":38,"phoneExt":38,"email":38},"Cagatay Ozsoy, MD",{"facility":109,"status":95,"city":96,"state":97,"zip":38,"country":98,"countryCode":38,"cosmosGeoPoint":110,"geoPoint":112,"contacts":113},"Aydin City Hospital, Department of Urology",{"type":100,"coordinates":111},[102,103],{"lat":103,"lon":102},[114],{"name":84,"role":86,"phone":38,"phoneExt":38,"email":38},{"facility":116,"status":95,"city":117,"state":117,"zip":38,"country":98,"countryCode":38,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Kutahya Health Sciences University, Department of Urology","Kütahya",{"type":100,"coordinates":119},[120,121],29.98333,39.42417,{"lat":121,"lon":120},[124],{"name":125,"role":86,"phone":38,"phoneExt":38,"email":38},"Seref Coser, MD",{"type":86,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Ahmet Emre YILDIZ","Urology Specialist, MD",[130,132],{"name":85,"class":131},"UNKNOWN",{"name":133,"class":6},"Kutahya Health Sciences University","100659010","human-voice-vs-ai-cloned-voice-audio-added-to-written-consent-before-ureteroscopy-or-retrograde-intrarenal-surgery-audio-consent-100659010",false,"NCT07859436","Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)","Effect of Adding a Urologist's Recorded Voice or an AI Clone of the Same Voice to Written Informed Consent on Knowledge, Anxiety, and Satisfaction in Patients Scheduled for Ureteroscopy or Retrograde Intrarenal Surgery: A Multicenter, Three-Arm Randomized Controlled Trial","AUDIO-CONSENT","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective ureteroscopy (URS) or retrograde intrarenal surgery (RIRS)\n* Able to read, understand and communicate verbally in Turkish\n* Provides written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Hearing or visual impairment preventing use of the study materials\n* Confusion, dementia, psychosis or any other condition affecting capacity to consent\n* Emergency surgery\n* Previous URS or RIRS\n* Current psychiatric treatment or use of anxiolytics\n* Health-care professional","ALL","18 Years",{"count":145,"type":146},240,"ESTIMATED","INTERVENTIONAL",[149],"NA","Before kidney stone surgery with a flexible or semirigid ureteroscope, patients must read and sign a written consent form, but many patients find these forms long and hard to understand. This study tests whether listening to an audio recording of the same consent form, in addition to the usual written form and the surgeon's explanation, helps patients understand the operation better. It also asks whether it matters if the recording is read by a real urologist or produced by artificial intelligence (AI) from a clone of that same urologist's voice.\n\nAdults scheduled for their first ureteroscopy or retrograde intrarenal surgery at three hospitals in Turkey will be randomly assigned to one of three groups: (A) standard written consent only, (B) standard consent plus an audio recording read by a urologist, or (C) standard consent plus the same text produced by an AI-cloned version of the same urologist's voice. All three groups receive exactly the same information, word for word; only the way it is delivered differs. Patients in group C are told that the voice was produced by AI.\n\nThe main outcome is a 10-question knowledge test on the content of the consent form, taken immediately after the consent process. Anxiety (State-Trait Anxiety Inventory) and satisfaction are also measured on the same day. No forms are completed on the day of surgery.",[152,153,154,155],"Urolithiasis","Kidney Calculi","Ureteral Calculi","Informed Consent",[157,158,159,160,161,162,163],"audio informed consent","voice cloning","artificial intelligence","patient comprehension","ureteroscopy","retrograde intrarenal surgery","preoperative anxiety","2026-10-03",{"date":166,"type":167},"2026-10-07","ACTUAL",{"date":169,"type":167},"2026-09-28",{"date":171,"type":146},"2027-04",{"name":5,"class":6},3]