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

May 22, 2023 updated by: Jeong-Hwa Seo, Seoul National University Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: Silence group
The headphones are placed on the pediatric patient, but there is no sound in the audio file being played.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paediatric Assessment of Emergence Delirium (PAED) score
Time Frame: within 1hr after the end of surgery (every 10 minutes, the score will be checked)
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)
Time Frame: within 1hr after the end of surgery
within 1hr after the end of surgery
EEG analysis during emergence period
Time Frame: 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
Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2023

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

June 20, 2025

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pediatric ED_binaural beat

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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