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Completed

NCT Number: NCT07630922

Influence of Intraoperative Auditory Intervention on Emergence Delirium in Preschoolers: A Randomised Controlled Clinical Trial

Emergence delirium (ED), characterized by disorientation and altered cognitive behavior, is a common postoperative complication in pediatric surgery. It manifests as lack of eye contact with caregivers or parents, aimless kicking and screaming, and inability to be soothed. Auditory stimulation has been shown to reduce the incidence of ED and postoperative pain during emergence following general anesthesia in children. Therefore, this study aimed to investigate the effects of different types of auditory interventions on the incidence of emergence delirium in children undergoing tonsillectomy and/or adenoidectomy under sevoflurane anesthesia.

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Key information

Conditions

Emergence Delirium, Anesthesia Confusion Delirium Emergence Agitation Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Preschool Age Children Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 3 and 7 years;
  • American Society of Anesthesiologists (ASA) physical status classification of I or II;
  • Pediatric patients scheduled for elective tonsillectomy and/or adenoidectomy under sevoflurane general anesthesia.

Exclusion criteria

  • Emergency surgery
  • The child has developmental delays or neurological disorders, deafness, or hearing impairment
  • The mother is deaf or absent
  • The patient and family members declined to participate.

Treatment and study plan

Classical Music Group

Other

Repeatedly played Mozart's Lullaby via Bluetooth headphones at 45-60 at 45-60 dB during surgery

Mother's Heartbeat Recording Group

Other

Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery

Mother's Lullaby Recording Group

Other

Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery

Primary outcomes

  1. The incidence of emergence delirium

    Time frame: Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed.

    According to the Pediatric Anesthesia Emergency Delirium Scale (PAED), the occurrence of ED is defined as a PAED score ≥10 at any time during the PACU period (PAED score range: 0-20).

Secondary outcomes

  1. The incidence of emergence pain

    Time frame: Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed

    If the Face, Legs, Activity, Cry and Consolability (FLACC) scale ≥ 4 (0 [no pain] ~ 10 [worst pain]), the child was considered to be in pain.

  2. Incidence of postoperative adverse events

    Time frame: Perioperative

    Including postoperative nausea and vomiting, excessive secretions, laryngospasm, respiratory depression, bradycardia, hypotension

  3. PACU Stay Duration

    Time frame: From PACU admission to PACU discharge

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

The Effect of Intraoperative Auditory Intervention on Emergence Delirium After Sevoflurane Anesthesia in Preschool Children

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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