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

3 ottobre 2026 aggiornato da: Ahmet Emre YILDIZ, Aydin Adnan Menderes University

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Design: multicenter, prospective, parallel-group, three-arm (1:1:1) randomized controlled trial with outcome-assessor and analyst blinding.

Stimuli: The same unified URS/RIRS 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").

Randomization: computer-generated, stratified by center (3) and education level (middle school or less / 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.

Hypotheses (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.

Sample 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.

Analysis: 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.

Analysis 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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
    • Aydın
      • Aydin, Aydın, Turchia (Türkiye)
        • Reclutamento
        • Aydin Adnan Menderes University, Department of Urology
        • Investigatore principale:
          • Cagatay Ozsoy, MD
      • Aydin, Aydın, Turchia (Türkiye)
        • Reclutamento
        • Aydin City Hospital, Department of Urology
        • Investigatore principale:
          • Ahmet Emre Yildiz, MD
    • Kütahya
      • Kütahya, Kütahya, Turchia (Türkiye)
        • Reclutamento
        • Kutahya Health Sciences University, Department of Urology
        • Investigatore principale:
          • Seref Coser, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: A: Written consent (standard care)

Standard care: the unified written consent form plus the physician's usual verbal explanation. No audio recording.
Altro: 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.
Sperimentale: B: Written consent + urologist-read audio

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.
Altro: 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.

Comportamentale: 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".
Sperimentale: 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.
Altro: 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.

Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post-consent knowledge score
Lasso di tempo: Day of consent, immediately after completion of the consent process (before surgery)

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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post-consent state anxiety (STAI-S)
Lasso di tempo: Day of consent, immediately after the consent process

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
Patient satisfaction and perceived clarity
Lasso di tempo: Day of consent, immediately after the consent process

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.
Day of consent, immediately after the consent process
Perceived naturalness and usefulness of the audio recording (arms B and C)
Lasso di tempo: Day of consent, immediately after the consent process

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/usefulness. Asked in both audio arms.
Day of consent, immediately after the consent process
Acceptability of the AI-generated voice (arm C)
Lasso di tempo: Day of consent, immediately after the consent process

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.
Day of consent, immediately after the consent process
Number of audio replays (arms B and C)
Lasso di tempo: Day of consent (during the consent session)

Number of times the patient chose to replay the audio recording.
Day of consent (during the consent session)
Self-reported reading of the written consent form
Lasso di tempo: Day of consent, immediately after the consent process

Single item with four categories: read all of it / read most of it / skimmed it / did not read it.
Day of consent, immediately after the consent process
Withdrawal from or postponement of the planned procedure
Lasso di tempo: From the consent process to the scheduled date of surgery (up to 7 days)

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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Aydin Adnan Menderes University

Collaboratori

Kutahya Health Sciences University
Aydin City Hospital

Investigatori

  • Investigatore principale: Ahmet Emre Yildiz, MD, Aydin City Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 settembre 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

30 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 settembre 2026

Primo Inserito (Effettivo)

5 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AUDIOCONSENT-URS-2026
  • 2026/364 (Altro identificatore: Aydin Adnan Menderes University Non-Interventional Clinical Research Ethics Committee (approved 17 Sep 2026))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Fully anonymized individual participant data underlying the results reported in publications (knowledge test item scores, STAI scores, questionnaire responses and baseline covariates), together with the data dictionary. Direct and indirect identifiers will be removed or aggregated before sharing.

Periodo di condivisione IPD

Beginning 6 months after publication of the primary results.

Criteri di accesso alla condivisione IPD

Researchers who submit a methodologically sound proposal to the principal investigator. Data are shared after approval of the proposal, approval by the responsible ethics committee where required, and signing of a data-sharing agreement, in accordance with Turkish personal data protection law (KVKK).

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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