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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. oktober 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

240

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: A: Written consent (standard care)

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

Atferdsmessig: 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".
Eksperimentell: 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.
Annen: 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.

Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post-consent knowledge score
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post-consent state anxiety (STAI-S)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Aydin Adnan Menderes University

Samarbeidspartnere

Kutahya Health Sciences University
Aydin City Hospital

Etterforskere

  • Hovedetterforsker: Ahmet Emre Yildiz, MD, Aydin City Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. september 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. april 2027

Datoer for studieregistrering

Først innsendt

30. september 2026

Først innsendt som oppfylte QC-kriteriene

30. september 2026

Først lagt ut (Faktiske)

5. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 6 months after publication of the primary results.

Tilgangskriterier for IPD-deling

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).

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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