Back to resultsThe Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
Primary Purpose
Emergence Delirium
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Binaural beats
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Delirium
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Binaural beats group
Silence group
Arm 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.
The headphones are placed on the pediatric patient, but there is no sound in the audio file being played.
Outcomes
Primary Outcome Measures
Incidence of emergence delirium in postanesthetic care unit (PACU)
Secondary Outcome Measures
Paediatric Assessment of Emergence Delirium (PAED) score
Pain score (The Face, Legs, Activity, Cry and Consolability score)
EEG analysis during emergence period
alpha, beta, gamma, delta, slow wave power and their ratio
Full Information
NCT ID
NCT05883280
First Posted
April 21, 2023
Last Updated
May 22, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05883280
Brief Title
The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
Official Title
The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2023 (Anticipated)
Primary Completion Date
May 20, 2025 (Anticipated)
Study Completion Date
June 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Binaural beats group
Arm Type
Experimental
Arm 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.
Arm Title
Silence group
Arm Type
No Intervention
Arm Description
The headphones are placed on the pediatric patient, but there is no sound in the audio file being played.
Intervention Type
Other
Intervention Name(s)
Binaural beats
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of emergence delirium in postanesthetic care unit (PACU)
Time Frame
within 1hr after the end of surgery
Secondary Outcome Measure Information:
Title
Paediatric Assessment of Emergence Delirium (PAED) score
Time Frame
within 1hr after the end of surgery (every 10 minutes, the score will be checked)
Title
Pain score (The Face, Legs, Activity, Cry and Consolability score)
Time Frame
within 1hr after the end of surgery
Title
EEG analysis during emergence period
Description
alpha, beta, gamma, delta, slow wave power and their ratio
Time Frame
Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Hyun Lee, MD
Phone
2-2072-3661
Ext
+82
Email
muslab6@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
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