Emergence DeliriumNCT05883280
The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
A study testing Binaural beats in people with Emergence Delirium, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Binaural beats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2023to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under the age of 7 receiving a strabismus surgery under general anesthesia.
- American Society of Anesthesiologists Physical status classification 1-2.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Binaural beats
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural beatsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence delirium in postanesthetic care unit (PACU)
Measured: within 1hr after the end of surgery
Secondary outcomes (3)
Paediatric Assessment of Emergence Delirium (PAED) score
Measured: 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)
Measured: within 1hr after the end of surgery
EEG analysis during emergence period
alpha, beta, gamma, delta, slow wave power and their ratio
Measured: Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 May 2023 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883280
- Sponsor's protocol ID
- pediatric ED_binaural beat
- Status last verified
- May 2023
- First submitted
- 21 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park JB, Lee JH, Kim YJ, Lee DJ, Seo JH. The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial. Paediatr Anaesth. 2026 May;36(5):510-519. doi: 10.1002/pan.70137. Epub 2026 Feb 6.
PubMed 41646000
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
- ClinicalTrials.gov ID
- NCT05883280
- Acronym / sponsor ID
- pediatric ED_binaural beat
- Conditions
- Emergence Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binaural beats group | Experimental | Other: Binaural beatsStarting 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. |
| Silence group | No intervention | –The headphones are placed on the pediatric patient, but there is no sound in the audio file being played. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children under the age of 7 receiving a strabismus surgery under general anesthesia.
- American Society of Anesthesiologists Physical status classification 1-2.
Key exclusion criteria (3 listed)
- Pediatric patients with hearing impairment or those who are currently using a hearing aid
- Pediatric patients with neurological disorders
- Pediatric patients with respiratory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural beatsThe 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. | Other | Binaural beats group |
Primary outcome
Incidence of emergence delirium in postanesthetic care unit (PACU)
Time frame: within 1hr after the end of surgery
3 secondary outcomes
Paediatric Assessment of Emergence Delirium (PAED) score
Time frame: 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)
Time frame: within 1hr after the end of surgery
EEG analysis during emergence period
Time frame: Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 41646000Park JB, Lee JH, Kim YJ, Lee DJ, Seo JH. The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial. Paediatr Anaesth. 2026 May;36(5):510-519. doi: 10.1002/pan.70137. Epub 2026 Feb 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural beats in people with Emergence Delirium, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Hyun Lee, MD (2-2072-3661 ext. +82, muslab6@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence delirium in postanesthetic care unit (PACU) (time frame: within 1hr after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.