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

NCT05883280 | Unknown

• 1 other identifier: pediatric ED_binaural beat
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence delirium in postanesthetic care unit (PACU)

  within 1hr after the end of surgery

Secondary Outcomes (3)

• 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)

Study Arms (2)

Binaural beats group

EXPERIMENTAL

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

Silence group

NO INTERVENTION

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

Interventions

Binaural beats 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.

Binaural beats group

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ji-Hyun Lee, MD

CONTACT

2-2072-3661; muslab6@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 31, 2023
• Study Start: May 20, 2023
• Primary Completion: May 20, 2025
• Study Completion: June 20, 2025
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

KR (1)