AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy
10. juli 2026 oppdatert av: Nezir Yılmaz, Adiyaman University Research Hospital
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: NEZİR YILMAZ, Associate Professor
- Telefonnummer: +905068939496
- E-post: yilmaznezir@hotmail.com
Studiesteder
-
-
-
Adıyaman, Tyrkia (Türkiye), 02200
- Adıyaman University
-
Ta kontakt med:
- Nezir Yılmaz
- Telefonnummer: 05068939496
- E-post: yilmaznezir@hotmail.com
-
-
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
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: AI-Generated Maternal Voice Storytelling group
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.
|
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.
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.
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.
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.
|
|
Eksperimentell: Relaxing Instrumental Music group
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.
|
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.
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.
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.
Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.
|
|
Aktiv komparator: Control group
Participants will receive standard perioperative care without headphones or auditory intervention.
Standardized general anesthesia will be administered according to the study protocol.
|
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.
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.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Emergence Delirium
Tidsramme: 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.
|
From admission to the post-anesthesia care unit until 30 minutes after arrival.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Induction Compliance
Tidsramme: During anesthetic induction.
|
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.
|
During anesthetic induction.
|
|
Sevoflurane Consumption
Tidsramme: Throughout the intraoperative period.
|
Intraoperative sevoflurane consumption will be recorded from anesthesia machine data during the maintenance phase of anesthesia.
|
Throughout the intraoperative period.
|
|
Mean Arterial Pressure (MAP)
Tidsramme: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
|
Mean arterial pressure (MAP), measured in mmHg, will be recorded at predefined perioperative time points to evaluate hemodynamic responses to the assigned intervention.
|
Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
|
|
Heart Rate (HR)
Tidsramme: Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
|
Heart rate (HR), measured in beats per minute (bpm), will be recorded to evaluate perioperative hemodynamic responses to the assigned intervention.
|
Baseline , and at 5, 15, 30, and 45 minutes after anesthesia induction.
|
|
Heart Rate Variability (HRV)
Tidsramme: Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.
|
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.
|
Baseline, and at 5, 15, 30, and 45 minutes after anesthesia induction.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Antatt)
20. juli 2026
Primær fullføring (Antatt)
20. september 2026
Studiet fullført (Antatt)
20. september 2026
Datoer for studieregistrering
Først innsendt
6. juli 2026
Først innsendt som oppfylte QC-kriteriene
10. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ADYU-ANS-NY-015
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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. .