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AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy

10 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Outro: AI-Generated Maternal Voice Storytelling
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.
Medicamento: midazolam premedication
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.
Procedimento: Standard General Anesthesia Care
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.
Dispositivo: Headphones
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.
Experimental: 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.
Medicamento: midazolam premedication
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.
Procedimento: Standard General Anesthesia Care
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.
Dispositivo: Headphones
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.
Outro: Relaxing Instrumental Music
Relaxing instrumental music delivered through headphones after preoperative sedation and continued throughout the perioperative period until recovery.
Comparador Ativo: Control group
Participants will receive standard perioperative care without headphones or auditory intervention. Standardized general anesthesia will be administered according to the study protocol.
Medicamento: midazolam premedication
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.
Procedimento: Standard General Anesthesia Care
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.
Dispositivo: Headphones
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Emergence Delirium
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Induction Compliance
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Adiyaman University Research Hospital

Datas de registro do estudo

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Datas Principais do Estudo

Início do estudo (Estimado)

20 de julho de 2026

Conclusão Primária (Estimado)

20 de setembro de 2026

Conclusão do estudo (Estimado)

20 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de julho de 2026

Primeira postagem (Real)

16 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ADYU-ANS-NY-015

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