PediatricNCT07706725
AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy
A study testing AI-Generated Maternal Voice Storytelling, Relaxing Instrumental Music and midazolam premedication in people with Pediatric and Adenotonsillectomy, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, three-arm randomized controlled trial aims to evaluate the effects of AI-generated maternal voice storytelling on the perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Pediatric, Adenotonsillectomy
- What is being tested?
- AI-Generated Maternal Voice Storytelling, Relaxing Instrumental Music and midazolam premedication
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 20 Sep 2026
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 12 years.
- Scheduled for elective adenotonsillectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Hearing impairment or inability to receive auditory stimulation.
- Developmental delay, neurological or psychiatric disorders.
- Use of sedative, antipsychotic, or anticonvulsant medications.
- Known allergy or contraindication to study medications.
- Refusal of participation by the parent/legal guardian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adıyaman University
Adıyaman, 02200
Nezir Yılmaz, 05068939496, yilmaznezir@hotmail.com
About this study
Official title: AI-Generated Maternal Voice Storytelling Modulates the Perioperative Stress Response and Reduces Emergence Delirium in Children Undergoing Adenotonsillectomy: A Three-Arm Randomized Controlled Trial
This prospective, three-arm randomized controlled trial aims to evaluate the effects of AI-generated maternal voice storytelling on the perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy. Participants will be randomly assigned to receive AI-generated maternal voice storytelling, relaxing instrumental music, or standard perioperative care. Standardized anesthesia protocols will be used in all groups, and perioperative outcomes will be compared among the three study arms.
Read the detailed description
Pediatric adenotonsillectomy is frequently associated with perioperative anxiety, autonomic stress responses, and emergence delirium despite standardized anesthetic management. Non-pharmacological auditory interventions, including music and maternal voice exposure, have been investigated as potential strategies to improve perioperative outcomes. However, the effects of personalized artificial intelligence (AI)-generated maternal voice storytelling have not been evaluated in pediatric surgical patients.
This prospective, single-center, three-arm randomized controlled trial will investigate the effects of AI-generated maternal voice storytelling on perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy under general anesthesia. Participants will be randomly assigned to one of three groups: (1) AI-generated maternal voice storytelling, (2) relaxing instrumental music, or (3) standard care without auditory intervention.
The assigned auditory intervention will be initiated after premedication and continued throughout the perioperative period using headphones. Standardized anesthesia protocols will be applied to all participants. Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes will include induction compliance, perioperative hemodynamic variables, sevoflurane consumption, postoperative pain scores, and recovery characteristics. The study aims to determine whether personalized AI-generated maternal voice storytelling influences perioperative outcomes compared with relaxing music and standard perioperative care.
- Conditions
- Pediatric, Adenotonsillectomy
- Being tested
- AI-Generated Maternal Voice Storytelling, Relaxing Instrumental Music, midazolam premedication, Standard General Anesthesia Care, Headphones
- Keywords
- Pediatric Adenotonsillectomy, Emergence Delirium, AI-Generated Maternal Voice, Perioperative Stress Response
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Generated Maternal Voice StorytellingOther
Personalized storytelling generated using artificial intelligence voice synthesis based on a pre-recorded maternal voice sample. The audio intervention will be delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.
Relaxing Instrumental MusicOther
Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.
midazolam premedicationDrug
All participants receive intravenous midazolam as standard premedication before anesthesia induction according to the institutional pediatric anesthesia protocol to reduce preoperative anxiety and facilitate smooth separation from parents.
Standard General Anesthesia CareProcedure or surgery
All participants receive standardized general anesthesia according to the institutional pediatric anesthesia protocol. Anesthesia is induced with intravenous propofol, fentanyl, and rocuronium, followed by endotracheal intubation. Anesthesia is maintained with sevoflurane in an oxygen/air mixture throughout the surgical procedure. Intraoperative monitoring and anesthetic management are standardized for all study groups.
HeadphonesDevice
Over-ear headphones are used in all study groups during the perioperative period. In the AI-generated maternal voice storytelling and relaxing music groups, the headphones deliver the assigned auditory intervention. In the control group, headphones are worn without audio playback to minimize exposure to environmental noise and to maintain consistency across study groups.
| Study group | Role | What they receive |
|---|---|---|
| AI-Generated Maternal Voice Storytelling group | Experimental | Participants will receive personalized AI-generated maternal voice storytelling through headphones beginning after preoperative sedation and continuing throughout the perioperative period until recovery. The audio will be created from a pre-recorded maternal voice sample using artificial intelligence voice synthesis. Standardized general anesthesia will be administered. Receives: Other: AI-Generated Maternal Voice Storytelling; Drug: midazolam premedication; Procedure: Standard General Anesthesia Care; Device: Headphones |
| Relaxing Instrumental Music group | Experimental | Participants will receive relaxing instrumental music through headphones beginning after preoperative sedation and continuing throughout the perioperative period until recovery. Standardized general anesthesia will be administered. Receives: Other: Relaxing Instrumental Music; Drug: midazolam premedication; Procedure: Standard General Anesthesia Care; Device: Headphones |
| Control group | Active comparator | Participants will receive standard perioperative care without headphones or auditory intervention. Standardized general anesthesia will be administered according to the study protocol. Receives: Drug: midazolam premedication; Procedure: Standard General Anesthesia Care; Device: Headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence Delirium
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) Scale. The PAED Scale consists of five items, with total scores ranging from 0 to 20. Higher scores indicate more severe emergence delirium, whereas lower scores indicate less or no emergence delirium.
Measured: From admission to the post-anesthesia care unit until 30 minutes after arrival.
Secondary outcomes (5)
Induction Compliance
Induction compliance will be assessed using the Induction Compliance Checklist (ICC). The ICC consists of 10 behavioral items, with total scores ranging from 0 to 10. Lower scores indicate better compliance with anesthesia induction, whereas higher scores indicate poorer compliance and greater distress during induction.
Measured: During anesthetic induction.
Sevoflurane Consumption
Intraoperative sevoflurane consumption will be recorded from anesthesia machine data during the maintenance phase of anesthesia.
Measured: Throughout the intraoperative period.
Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP), measured in mmHg, will be recorded at predefined perioperative time points to evaluate hemodynamic responses to the assigned intervention.
Measured: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Heart Rate (HR)
Heart rate (HR), measured in beats per minute (bpm), will be recorded to evaluate perioperative hemodynamic responses to the assigned intervention.
Measured: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Heart Rate Variability (HRV)
Heart rate variability (HRV) parameters, including time-domain (e.g., SDNN and RMSSD) and frequency-domain (e.g., LF, HF, and LF/HF ratio) indices, will be analyzed to assess autonomic nervous system activity and perioperative stress responses associated with the assigned intervention.
Measured: Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: AI-generated maternal voice storytelling, relaxing instrumental music, or standard perioperative care without auditory intervention. The assigned auditory intervention will be initiated after preoperative sedation and continued throughout the perioperative period until recovery. All participants will receive the same standardized anesthetic protocol, and outcomes will be compared across the three study groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706725
- Sponsor's protocol ID
- ADYU-ANS-NY-015
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Generated Maternal Voice Storytelling Modulates the Perioperative Stress Response and Reduces Emergence Delirium in Children Undergoing Adenotonsillectomy: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07706725
- Acronym / sponsor ID
- ADYU-ANS-NY-015
- Conditions
- Pediatric, Adenotonsillectomy
- Keywords
- Pediatric Adenotonsillectomy, Emergence Delirium, AI-Generated Maternal Voice, Perioperative Stress Response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 16 Jul 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.
This prospective, three-arm randomized controlled trial aims to evaluate the effects of AI-generated maternal voice storytelling on the perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy. Participants will be randomly assigned to receive AI-generated maternal voice storytelling, relaxing instrumental music, or standard perioperative care. Standardized anesthesia protocols will be used in all groups, and perioperative outcomes will be compared among the three study arms.
Detailed description
Pediatric adenotonsillectomy is frequently associated with perioperative anxiety, autonomic stress responses, and emergence delirium despite standardized anesthetic management. Non-pharmacological auditory interventions, including music and maternal voice exposure, have been investigated as potential strategies to improve perioperative outcomes. However, the effects of personalized artificial intelligence (AI)-generated maternal voice storytelling have not been evaluated in pediatric surgical patients.
This prospective, single-center, three-arm randomized controlled trial will investigate the effects of AI-generated maternal voice storytelling on perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy under general anesthesia. Participants will be randomly assigned to one of three groups: (1) AI-generated maternal voice storytelling, (2) relaxing instrumental music, or (3) standard care without auditory intervention.
The assigned auditory intervention will be initiated after premedication and continued throughout the perioperative period using headphones. Standardized anesthesia protocols will be applied to all participants. Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes will include induction compliance, perioperative hemodynamic variables, sevoflurane consumption, postoperative pain scores, and recovery characteristics. The study aims to determine whether personalized AI-generated maternal voice storytelling influences perioperative outcomes compared with relaxing music and standard perioperative care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: AI-generated maternal voice storytelling, relaxing instrumental music, or standard perioperative care without auditory intervention. The assigned auditory intervention will be initiated after preoperative sedation and continued throughout the perioperative period until recovery. All participants will receive the same standardized anesthetic protocol, and outcomes will be compared across the three study groups.
| Arm | Type | Receives |
|---|---|---|
| AI-Generated Maternal Voice Storytelling group | Experimental | Other: AI-Generated Maternal Voice Storytelling, Drug: midazolam premedication, Procedure: Standard General Anesthesia Care, Device: HeadphonesParticipants will receive personalized AI-generated maternal voice storytelling through headphones beginning after preoperative sedation and continuing throughout the perioperative period until recovery. The audio will be created from a pre-recorded maternal voice sample using artificial intelligence voice synthesis. Standardized general anesthesia will be administered. |
| Relaxing Instrumental Music group | Experimental | Other: Relaxing Instrumental Music, Drug: midazolam premedication, Procedure: Standard General Anesthesia Care, Device: HeadphonesParticipants will receive relaxing instrumental music through headphones beginning after preoperative sedation and continuing throughout the perioperative period until recovery. Standardized general anesthesia will be administered. |
| Control group | Active comparator | Drug: midazolam premedication, Procedure: Standard General Anesthesia Care, Device: HeadphonesParticipants will receive standard perioperative care without headphones or auditory intervention. Standardized general anesthesia will be administered according to the study protocol. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3 to 12 years.
- Scheduled for elective adenotonsillectomy under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent or legal guardian.
Key exclusion criteria (5 listed)
- Hearing impairment or inability to receive auditory stimulation.
- Developmental delay, neurological or psychiatric disorders.
- Use of sedative, antipsychotic, or anticonvulsant medications.
- Known allergy or contraindication to study medications.
- Refusal of participation by the parent/legal guardian.
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 |
|---|---|---|
| AI-Generated Maternal Voice StorytellingPersonalized storytelling generated using artificial intelligence voice synthesis based on a pre-recorded maternal voice sample. The audio intervention will be delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery. | Other | AI-Generated Maternal Voice Storytelling group |
| Relaxing Instrumental MusicRelaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery. | Other | Relaxing Instrumental Music group |
| midazolam premedicationAll participants receive intravenous midazolam as standard premedication before anesthesia induction according to the institutional pediatric anesthesia protocol to reduce preoperative anxiety and facilitate smooth separation from parents. | Drug | AI-Generated Maternal Voice Storytelling group, Control group, Relaxing Instrumental Music group |
| Standard General Anesthesia CareAll participants receive standardized general anesthesia according to the institutional pediatric anesthesia protocol. Anesthesia is induced with intravenous propofol, fentanyl, and rocuronium, followed by endotracheal intubation. Anesthesia is maintained with sevoflurane in an oxygen/air mixture throughout the surgical procedure. Intraoperative monitoring and anesthetic management are standardized for all study groups. | Procedure or surgery | AI-Generated Maternal Voice Storytelling group, Control group, Relaxing Instrumental Music group |
| HeadphonesOver-ear headphones are used in all study groups during the perioperative period. In the AI-generated maternal voice storytelling and relaxing music groups, the headphones deliver the assigned auditory intervention. In the control group, headphones are worn without audio playback to minimize exposure to environmental noise and to maintain consistency across study groups. | Device | AI-Generated Maternal Voice Storytelling group, Control group, Relaxing Instrumental Music group |
Primary outcome
Emergence Delirium
Time frame: From admission to the post-anesthesia care unit until 30 minutes after arrival.
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) Scale. The PAED Scale consists of five items, with total scores ranging from 0 to 20. Higher scores indicate more severe emergence delirium, whereas lower scores indicate less or no emergence delirium.
5 secondary outcomes
Induction Compliance
Time frame: During anesthetic induction.
Sevoflurane Consumption
Time frame: Throughout the intraoperative period.
Mean Arterial Pressure (MAP)
Time frame: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Heart Rate (HR)
Time frame: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
Heart Rate Variability (HRV)
Time frame: Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.
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 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Generated Maternal Voice Storytelling, Relaxing Instrumental Music and midazolam premedication in people with Pediatric and Adenotonsillectomy, run by Adiyaman University Research Hospital at 1 site 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 5 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: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 NEZİR YILMAZ, Associate Professor (+905068939496, yilmaznezir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence Delirium (time frame: From admission to the post-anesthesia care unit until 30 minutes after arrival.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.