AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy
10 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
90
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: NEZİR YILMAZ, Associate Professor
- Numéro de téléphone: +905068939496
- E-mail: yilmaznezir@hotmail.com
Lieux d'étude
-
-
-
Adıyaman, Turquie (Türkiye), 02200
- Adıyaman University
-
Contact:
- Nezir Yılmaz
- Numéro de téléphone: 05068939496
- E-mail: yilmaznezir@hotmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Emergence Delirium
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Induction Compliance
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
20 juillet 2026
Achèvement primaire (Estimé)
20 septembre 2026
Achèvement de l'étude (Estimé)
20 septembre 2026
Dates d'inscription aux études
Première soumission
6 juillet 2026
Première soumission répondant aux critères de contrôle qualité
10 juillet 2026
Première publication (Réel)
16 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ADYU-ANS-NY-015
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .