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

Seoul National University

Status: Not yet enrolling

Conditions: Emergence Delirium

Treatments: Other: Binaural beats

Study type: Interventional

Funder types: Other

Identifiers

NCT05883280

pediatric ED_binaural beat

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: Under 7 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

74 participants in 2 patient groups

Binaural beats group

Experimental group

Description:

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.

Treatment:

Other: Binaural beats

Silence group

No Intervention group

Description:

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