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

NCT ID: NCT05883280

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2025-06-20

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.

Detailed Description

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Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Binaural beats group

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.

Group Type EXPERIMENTAL

Binaural beats

Intervention Type OTHER

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.

Silence group

The headphones are placed on the pediatric patient, but there is no sound in the audio file being played.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Binaural beats

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.

Intervention Type OTHER

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
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Hwa Seo

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Ji-Hyun Lee, MD

Role: CONTACT

Phone: 2-2072-3661

Email: [email protected]

Other Identifiers

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pediatric ED_binaural beat

Identifier Type: -

Identifier Source: org_study_id