The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery

Not Applicable

Not yet recruiting

• Conditions: Emergence Delirium
• Interventions: Other: Binaural beats

• Registration Number: NCT05883280
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. To test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-21
• Status Verified: 2023-05
• Study Start: 2023-05-20
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Primary Completion: 2025-05-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Children under the age of 7 receiving a strabismus surgery under general anesthesia.
• American Society of Anesthesiologists Physical status classification 1-2.

Exclusion Criteria

• Pediatric patients with hearing impairment or those who are currently using a hearing aid
• Pediatric patients with neurological disorders
• Pediatric patients with respiratory disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Binaural beats group	Binaural beats	Starting 30 minutes before the end of the surgery, a continuous pure tone binaural beat is delivered through headphones to the pediatric patient, with a frequency of 432 Hz in the left ear and 420 Hz in the right ear.

Primary Outcome Measures

Name	Time	Method
Incidence of emergence delirium in postanesthetic care unit (PACU)	within 1hr after the end of surgery

Secondary Outcome Measures

Name	Time	Method
Pain score (The Face, Legs, Activity, Cry and Consolability score)	within 1hr after the end of surgery
Paediatric Assessment of Emergence Delirium (PAED) score	within 1hr after the end of surgery (every 10 minutes, the score will be checked)
EEG analysis during emergence period	Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery)	alpha, beta, gamma, delta, slow wave power and their ratio

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of