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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 октября 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

240

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Ahmet Emre Yildiz, MD
  • Номер телефона: +90 535 312 98 32
  • Электронная почта: aemreyildiz@gmail.com

Места учебы

  • Турция (Туркие)
    • Aydın
      • Aydin, Aydın, Турция (Туркие)
        • Рекрутинг
        • Aydin Adnan Menderes University, Department of Urology
        • Главный следователь:
          • Cagatay Ozsoy, MD
      • Aydin, Aydın, Турция (Туркие)
        • Рекрутинг
        • Aydin City Hospital, Department of Urology
        • Главный следователь:
          • Ahmet Emre Yildiz, MD
    • Kütahya
      • Kütahya, Kütahya, Турция (Туркие)
        • Рекрутинг
        • Kutahya Health Sciences University, Department of Urology
        • Главный следователь:
          • Seref Coser, MD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Исследования в области здравоохранения
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: A: Written consent (standard care)

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

Поведенческий: 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".
Экспериментальный: 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.
Другой: 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.

Поведенческий: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Post-consent knowledge score
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Post-consent state anxiety (STAI-S)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Aydin Adnan Menderes University

Соавторы

Kutahya Health Sciences University
Aydin City Hospital

Следователи

  • Главный следователь: Ahmet Emre Yildiz, MD, Aydin City Hospital

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

28 сентября 2026 г.

Первичное завершение (Оцененный)

1 марта 2027 г.

Завершение исследования (Оцененный)

1 апреля 2027 г.

Даты регистрации исследования

Первый отправленный

30 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

30 сентября 2026 г.

Первый опубликованный (Действительный)

5 октября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

7 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 октября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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.

Сроки обмена IPD

Beginning 6 months after publication of the primary results.

Критерии совместного доступа к 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).

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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