UrolithiasisAUDIO-CONSENTNCT07859436
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
A study testing Standard written informed consent, Human-voice audio consent recording and AI-cloned-voice audio consent recording in people with Urolithiasis and Kidney Calculi, run by Aydin Adnan Menderes University at 3 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Kidney Calculi, Ureteral Calculi
- What is being tested?
- Standard written informed consent, Human-voice audio consent recording and AI-cloned-voice audio consent recording
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 28 Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Aydin Adnan Menderes University, Department of Urology
Aydin, Aydın
Cagatay Ozsoy, MD
- Recruiting
Aydin City Hospital, Department of Urology
Aydin, Aydın
Ahmet Emre Yildiz, MD
- Recruiting
Kutahya Health Sciences University, Department of Urology
Kütahya, Kütahya
Seref Coser, MD
About this study
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
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.
Read the detailed description
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.
- Conditions
- Urolithiasis, Kidney Calculi, Ureteral Calculi, Informed Consent
- Being tested
- Standard written informed consent, Human-voice audio consent recording, AI-cloned-voice audio consent recording
- Keywords
- audio informed consent, voice cloning, artificial intelligence, patient comprehension, ureteroscopy, retrograde intrarenal surgery, preoperative anxiety
- Medical subject headings
- Urolithiasis, Kidney Calculi, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard written informed consentOther
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.
Human-voice audio consent recordingBehavioural
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".
AI-cloned-voice audio consent recordingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A: Written consent (standard care) | Active comparator | Standard care: the unified written consent form plus the physician's usual verbal explanation. No audio recording. Receives: Other: Standard written informed consent |
| B: Written consent + urologist-read audio | Experimental | 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. Receives: Other: Standard written informed consent; Behavioral: Human-voice audio consent recording |
| C: Written consent + AI-cloned voice audio | Experimental | 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. Receives: Other: Standard written informed consent; Behavioral: AI-cloned-voice audio consent recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-consent knowledge score
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.
Measured: Day of consent, immediately after completion of the consent process (before surgery)
Secondary outcomes (7)
Post-consent state anxiety (STAI-S)
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.
Measured: Day of consent, immediately after the consent process
Patient satisfaction and perceived clarity
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.
Measured: Day of consent, immediately after the consent process
Perceived naturalness and usefulness of the audio recording (arms B and C)
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.
Measured: Day of consent, immediately after the consent process
Acceptability of the AI-generated voice (arm C)
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.
Measured: Day of consent, immediately after the consent process
Number of audio replays (arms B and C)
Number of times the patient chose to replay the audio recording.
Measured: Day of consent (during the consent session)
Self-reported reading of the written consent form
Single item with four categories: read all of it / read most of it / skimmed it / did not read it.
Measured: Day of consent, immediately after the consent process
Withdrawal from or postponement of the planned procedure
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.
Measured: From the consent process to the scheduled date of surgery (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start28 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel-group randomized trial with 1:1:1 allocation, stratified by center and education level. Arms B and C receive the standard written consent process plus an audio recording of the identical consent text.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Collaborators
- Aydin City Hospital, Kutahya Health Sciences University
- Responsible party
- Principal investigator, Ahmet Emre YILDIZ, Aydin Adnan Menderes University
- Investigators
- Ahmet Emre Yildiz, MD, Principal investigator, Aydin City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859436
- Sponsor's protocol ID
- AUDIOCONSENT-URS-2026
- Other IDs
- 2026/364
- Acronym
- AUDIO-CONSENT
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Sun Y, Xu S, Jin H, Han X, Jin K, Zhang Y, Ma X, Wei H, Ma M. Effectiveness of Al-Assisted Patient Health Education Using Voice Cloning and ChatGPT: Prospective Randomized Controlled Trial. J Med Internet Res. 2026 Mar 19;28:e81387. doi: 10.2196/81387.
PubMed 41855493Haack M, Fischer ND, Frey L, Sparwasser P, Dotzauer R, Duwe G, Haferkamp A, Borgmann H. Digital informed consent for urological surgery - randomized controlled study comparing multimedia-supported vs. traditional paper-based informed consent concerning satisfaction, anxiety, information gain and time efficiency. Prostate Cancer Prostatic Dis. 2024 Dec;27(4):715-719. doi: 10.1038/s41391-023-00737-4. Epub 2023 Nov 4.
PubMed 37925488Goldberger JJ, Kruse J, Kadish AH, Passman R, Bergner DW. Effect of informed consent format on patient anxiety, knowledge, and satisfaction. Am Heart J. 2011 Oct;162(4):780-785.e1. doi: 10.1016/j.ahj.2011.07.006. Epub 2011 Sep 14.
PubMed 21982673Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 Feb;40(2):119-143. doi: 10.1177/0272989X19896348. Epub 2020 Jan 16.
PubMed 31948345
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07859436
- Acronym / sponsor ID
- AUDIO-CONSENT / AUDIOCONSENT-URS-2026
- Conditions
- Urolithiasis, Kidney Calculi, Ureteral Calculi, Informed Consent
- Keywords
- audio informed consent, voice cloning, artificial intelligence, patient comprehension, ureteroscopy, retrograde intrarenal surgery, preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Collaborators
- Aydin City Hospital, Kutahya Health Sciences University
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel-group randomized trial with 1:1:1 allocation, stratified by center and education level. Arms B and C receive the standard written consent process plus an audio recording of the identical consent text.
| Arm | Type | Receives |
|---|---|---|
| A: Written consent (standard care) | Active comparator | Other: Standard written informed consentStandard care: the unified written consent form plus the physician's usual verbal explanation. No audio recording. |
| B: Written consent + urologist-read audio | Experimental | Other: Standard written informed consent, Behavioral: Human-voice audio consent recordingStandard 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. |
| C: Written consent + AI-cloned voice audio | Experimental | Other: Standard written informed consent, Behavioral: AI-cloned-voice audio consent recordingStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard written informed consentThe 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. | Other | A: Written consent (standard care), B: Written consent + urologist-read audio, C: Written consent + AI-cloned voice audio |
| Human-voice audio consent recordingAn 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". | Behavioural | B: Written consent + urologist-read audio |
| AI-cloned-voice audio consent recordingThe 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. | Behavioural | C: Written consent + AI-cloned voice audio |
Primary outcome
Post-consent knowledge score
Time frame: 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.
7 secondary outcomes
Post-consent state anxiety (STAI-S)
Time frame: Day of consent, immediately after the consent process
Patient satisfaction and perceived clarity
Time frame: Day of consent, immediately after the consent process
Perceived naturalness and usefulness of the audio recording (arms B and C)
Time frame: Day of consent, immediately after the consent process
Acceptability of the AI-generated voice (arm C)
Time frame: Day of consent, immediately after the consent process
Number of audio replays (arms B and C)
Time frame: Day of consent (during the consent session)
Self-reported reading of the written consent form
Time frame: Day of consent, immediately after the consent process
Withdrawal from or postponement of the planned procedure
Time frame: From the consent process to the scheduled date of surgery (up to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 41855493Sun Y, Xu S, Jin H, Han X, Jin K, Zhang Y, Ma X, Wei H, Ma M. Effectiveness of Al-Assisted Patient Health Education Using Voice Cloning and ChatGPT: Prospective Randomized Controlled Trial. J Med Internet Res. 2026 Mar 19;28:e81387. doi: 10.2196/81387.
- Background: PubMed 37925488Haack M, Fischer ND, Frey L, Sparwasser P, Dotzauer R, Duwe G, Haferkamp A, Borgmann H. Digital informed consent for urological surgery - randomized controlled study comparing multimedia-supported vs. traditional paper-based informed consent concerning satisfaction, anxiety, information gain and time efficiency. Prostate Cancer Prostatic Dis. 2024 Dec;27(4):715-719. doi: 10.1038/s41391-023-00737-4. Epub 2023 Nov 4.
- Background: PubMed 21982673Goldberger JJ, Kruse J, Kadish AH, Passman R, Bergner DW. Effect of informed consent format on patient anxiety, knowledge, and satisfaction. Am Heart J. 2011 Oct;162(4):780-785.e1. doi: 10.1016/j.ahj.2011.07.006. Epub 2011 Sep 14.
- Background: PubMed 31948345Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 Feb;40(2):119-143. doi: 10.1177/0272989X19896348. Epub 2020 Jan 16.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmet Emre Yildiz, MD principal investigator
Aydin City Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard written informed consent, Human-voice audio consent recording and AI-cloned-voice audio consent recording in people with Urolithiasis and Kidney Calculi, run by Aydin Adnan Menderes University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Emre Yildiz, MD (+90 535 312 98 32, aemreyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-consent knowledge score (time frame: Day of consent, immediately after completion of the consent process (before surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07859436, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.