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

NCT07630922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-06-05

No results posted yet for this study

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

Interventions

OTHER

Classical Music Group

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

OTHER

Mother's Heartbeat Recording Group

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

OTHER

Mother's Lullaby Recording Group

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

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-11-30
Completion
2025-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630922 on ClinicalTrials.gov