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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05883280
Other study ID # pediatric ED_binaural beat
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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