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

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883280
• Other study ID #: pediatric ED_binaural beat
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: June 20, 2025

Study information

• Verified date: May 2023
• Source: Seoul National University Hospital
• Contact: Ji-Hyun Lee, MD
• Phone: 2-2072-3661
• Email: muslab6[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: June 20, 2025
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Strabismus

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of emergence delirium in postanesthetic care unit (PACU)		within 1hr after the end of surgery
Secondary	Paediatric Assessment of Emergence Delirium (PAED) score		within 1hr after the end of surgery (every 10 minutes, the score will be checked)
Secondary	Pain score (The Face, Legs, Activity, Cry and Consolability score)		within 1hr after the end of surgery
Secondary	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)