Audio consent with human voice or AI-voice added to written consent for ureteroscopy
Official title: 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
Run by Aydin Adnan Menderes University · NCT07859436 · Data updated 2026-11-12
This study tests if listening to an audio version of the consent form, read by a real urologist or by an AI-cloned voice, helps adults in Turkey understand their ureteroscopy or RIRS consent better than the written form alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Aydin Adnan Menderes University Academic / other |
| Locations | 3 sites (Aydin, Aydın and 2 other locations) |
| Status | Recruiting |
| Started | September 28, 2026 |
| Main results expected | March 2027 |
| Study ends | April 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07859436 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older scheduled for their first URS or RIRS, able to read and speak Turkish, and capable of using the study materials.
✕Probably not a fit
Patients with hearing or visual impairments preventing use of audio materials or those outside the Turkish-speaking population may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial assigns adults scheduled for first-time ureteroscopy or retrograde intrarenal surgery to three groups: written consent alone, written consent plus a human-voice audio recording, or written consent plus an AI-cloned voice recording. All groups receive the same information; audio is played after the standard consent steps and can be replayed with questions allowed. Outcome assessors are blinded, with randomization stratified by center and education level. The study uses a fixed voice clone produced from a separate reference recording and compares comprehension across arms. Primary aims focus on whether audio supplementation improves understanding of the procedure and consent content.
Why it matters
Potential benefit: If successful, patients may have better understanding of their procedure and consent terms, potentially improving satisfaction and informed decision-making.
How similar studies have gone: Previous work in consent delivery suggests audio aids can improve comprehension; this study applies a novel direct comparison between human and AI-generated voices.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Aydin Adnan Menderes University, Department of Urology
Aydin, Aydın, Turkey (Türkiye) Recruiting -
Aydin City Hospital, Department of Urology
Aydin, Aydın, Turkey (Türkiye) Recruiting -
Kutahya Health Sciences University, Department of Urology
Kütahya, Kütahya, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Ahmet Emre Yildiz, MD — Aydin City Hospital
- Study coordinator: Ahmet Emre Yildiz, MD
- Email: aemreyildiz@gmail.com
- Phone: +90 535 312 98 32
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.