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

Study acronym: AUDIO-CONSENT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Secondary endpoints: details revised at 7 of 7 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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. The 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.
Trial Details
NCT Number NCT07859436
Lead Sponsor Aydin Adnan Menderes University
Collaborators: Aydin City Hospital, Kutahya Health Sciences University
Conditions
(from sponsor)
Urolithiasis, Kidney Calculi, Ureteral Calculi, Informed Consent
Related terms Kidney Calculi, Ureteral Calculi, Urolithiasis
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov