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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05883280

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Delirium	Other: Binaural beats	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 20, 2023

Anticipated Primary Completion Date :

May 20, 2025

Anticipated Study Completion Date :

Jun 20, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of emergence delirium in postanesthetic care unit (PACU) [within 1hr after the end of surgery]

Secondary Outcome Measures

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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong-Hwa Seo, professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05883280

Other Study ID Numbers:

pediatric ED_binaural beat

First Posted:

May 31, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Strabismus

Emergence Delirium

Study Results

No Results Posted as of May 31, 2023