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Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)

RecruitingNAAges 18 Years - anyAllAydin Adnan Menderes University
NCT07859436 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Adults 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older * Scheduled for elective ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) * Able to read, understand and communicate verbally in Turkish * Provides written informed consent to participate in the study Exclusion Criteria: * Hearing or visual impairment preventing use of the study materials * Confusion, dementia, psychosis or any other condition affecting capacity to consent * Emergency surgery * Previous URS or RIRS * Current psychiatric treatment or use of anxiolytics * Health-care professional
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What it tests

  • Standard written informed consent
  • Human-voice audio consent recording
  • AI-cloned-voice audio consent recording
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Where

3 sites
Aydin Adnan Menderes University, Department of Urology
Aydin, Turkey (Türkiye)
Aydin City Hospital, Department of Urology
Aydin, Turkey (Türkiye)
Kutahya Health Sciences University, Department of Urology
Kütahya, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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