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

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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Agitation; Emergence Delirium, Anesthesia; Preschool Age Children
• Intervention / Treatment: Other: Classical Music Group; Other: Mother's Heartbeat Recording Group; Other: Mother's Lullaby Recording Group

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M Group	Other: Classical Music Group; Repeatedly played Mozart's Lullaby via Bluetooth headphones at 45-60 at 45-60 dB during surgery
Experimental: H Group	Other: Mother's Heartbeat Recording Group; Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery
Experimental: S Group	Other: Mother's Lullaby Recording Group; Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery
No Intervention: C Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of emergence delirium	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).	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of emergence pain	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.	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
Incidence of postoperative adverse events	Including postoperative nausea and vomiting, excessive secretions, laryngospasm, respiratory depression, bradycardia, hypotension	Perioperative
PACU Stay Duration		From PACU admission to PACU discharge

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: Henan-LKR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No