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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 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

240

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
    • Aydın
      • Aydin, Aydın, Turquie (Türkiye)
        • Recrutement
        • Aydin Adnan Menderes University, Department of Urology
        • Chercheur principal:
          • Cagatay Ozsoy, MD
      • Aydin, Aydın, Turquie (Türkiye)
        • Recrutement
        • Aydin City Hospital, Department of Urology
        • Chercheur principal:
          • Ahmet Emre Yildiz, MD
    • Kütahya
      • Kütahya, Kütahya, Turquie (Türkiye)
        • Recrutement
        • Kutahya Health Sciences University, Department of Urology
        • Chercheur principal:
          • Seref Coser, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: A: Written consent (standard care)

Standard care: the unified written consent form plus the physician's usual verbal explanation. No audio recording.
Autre: 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.
Expérimental: 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.
Autre: 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.

Comportemental: 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".
Expérimental: 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.
Autre: 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.

Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Post-consent knowledge score
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Post-consent state anxiety (STAI-S)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Aydin Adnan Menderes University

Collaborateurs

Kutahya Health Sciences University
Aydin City Hospital

Les enquêteurs

  • Chercheur principal: Ahmet Emre Yildiz, MD, Aydin City Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 septembre 2026

Achèvement primaire (Estimé)

1 mars 2027

Achèvement de l'étude (Estimé)

1 avril 2027

Dates d'inscription aux études

Première soumission

30 septembre 2026

Première soumission répondant aux critères de contrôle qualité

30 septembre 2026

Première publication (Réel)

5 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

Beginning 6 months after publication of the primary results.

Critères d'accès au partage 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).

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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