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

NCT07630922 | Completed

• 1 other identifier: Henan-LKR
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergence Delirium, Anesthesia; Preschool Age Children; Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The incidence of emergence 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

  Perioperative

• PACU Stay Duration

  From PACU admission to PACU discharge

Study Arms (4)

M Group

EXPERIMENTAL

Other: Classical Music Group

H Group

EXPERIMENTAL

Other: Mother's Heartbeat Recording Group

S Group

EXPERIMENTAL

Other: Mother's Lullaby Recording Group

C Group

NO INTERVENTION

Interventions

Classical Music Group OTHER

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

M Group

Mother's Heartbeat Recording Group OTHER

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

H Group

Mother's Lullaby Recording Group OTHER

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

S Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to one of four groups (e.g., by coin toss or lottery draw) with a 1:1:1:1 allocation ratio between the experimental and control groups. Neither participants, caregivers, nor outcome assessors will be aware of the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Classical Music Group M: Mozart's Lullaby played continuously during surgery via Bluetooth headphones at 45-60 decibels; Group H (Mother's Heartbeat Recording): Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery; Group S (Mother's Lullaby Recording): Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery; Control Group C: No intervention.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: June 5, 2026
• Study Start: March 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

CN (1)