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

Study Overview
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Brief Summary
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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.

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

Conditions
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Emergence Delirium

Intervention / Treatment
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* Other: Binaural beats


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binaural beats group<br>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. | Other: Binaural beats<br>* The binaural beat audio file consists of pure tones with a frequency of 432 Hz in the left ear and 420 Hz in the right ear. It is played through headphones starting 30 minutes before the end of the surgery.<br>|
| No Intervention: Silence group<br>The headphones are placed on the pediatric patient, but there is no sound in the audio file being played. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of emergence delirium in postanesthetic care unit (PACU) |  | within 1hr after the end of surgery | 

Secondary Outcome Measures

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