Emergence Delirium, AnesthesiaNCT07630922
Influence of Intraoperative Auditory Intervention on Emergence Delirium in Preschoolers: A Randomised Controlled Clinical Trial
A study testing Classical Music Group, Mother's Heartbeat Recording Group and Mother's Lullaby Recording Group in people with Emergence Delirium, Anesthesia and Preschool Age Children, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
Emergence delirium (ED), characterized by disorientation and altered cognitive behavior, is a common postoperative complication in pediatric surgery. It manifests as lack of eye contact with caregivers or parents, aimless kicking and screaming, and inability to be soothed. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Emergence Delirium, Anesthesia, Preschool Age Children, Emergence Agitation
- What is being tested?
- Classical Music Group, Mother's Heartbeat Recording Group and Mother's Lullaby Recording Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Dec 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 3 and 7 years;
- American Society of Anesthesiologists (ASA) physical status classification of I or II;
- Pediatric patients scheduled for elective tonsillectomy and/or adenoidectomy under sevoflurane general anesthesia.
Who cannot join
- Emergency surgery
- The child has developmental delays or neurological disorders, deafness, or hearing impairment
- The mother is deaf or absent
- The patient and family members declined to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Auditory Intervention on Emergence Delirium After Sevoflurane Anesthesia in Preschool Children
Emergence delirium (ED), characterized by disorientation and altered cognitive behavior, is a common postoperative complication in pediatric surgery. It manifests as lack of eye contact with caregivers or parents, aimless kicking and screaming, and inability to be soothed. Auditory stimulation has been shown to reduce the incidence of ED and postoperative pain during emergence following general anesthesia in children. Therefore, this study aimed to investigate the effects of different types of auditory interventions on the incidence of emergence delirium in children undergoing tonsillectomy and/or adenoidectomy under sevoflurane anesthesia.
- Being tested
- Classical Music Group, Mother's Heartbeat Recording Group, Mother's Lullaby Recording Group
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical Music GroupOther
Repeatedly played Mozart's Lullaby via Bluetooth headphones at 45-60 at 45-60 dB during surgery
Mother's Heartbeat Recording GroupOther
Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery
Mother's Lullaby Recording GroupOther
Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery
| Study group | Role | What they receive |
|---|---|---|
| M Group | Experimental | Not described Receives: Other: Classical Music Group |
| H Group | Experimental | Not described Receives: Other: Mother's Heartbeat Recording Group |
| S Group | Experimental | Not described Receives: Other: Mother's Lullaby Recording Group |
| C Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence delirium
According to the Pediatric Anesthesia Emergency Delirium Scale (PAED), the occurrence of ED is defined as a PAED score ≥10 at any time during the PACU period (PAED score range: 0-20).
Measured: Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed.
Secondary outcomes (3)
The incidence of emergence pain
If the Face, Legs, Activity, Cry and Consolability (FLACC) scale ≥ 4 (0 [no pain] ~ 10 [worst pain]), the child was considered to be in pain.
Measured: Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed
Incidence of postoperative adverse events
Including postoperative nausea and vomiting, excessive secretions, laryngospasm, respiratory depression, bradycardia, hypotension
Measured: Perioperative
PACU Stay Duration
Measured: From PACU admission to PACU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Mar 2025
- Primary completion30 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium, AnesthesiaStudies of the same condition, open and under way.
- 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
- Model description
- Classical Music Group M: Mozart's Lullaby played continuously during surgery via Bluetooth headphones at 45-60 decibels; Group H (Mother's Heartbeat Recording): Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery; Group S (Mother's Lullaby Recording): Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery; Control Group C: No intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630922
- Sponsor's protocol ID
- Henan-LKR
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Auditory Intervention on Emergence Delirium After Sevoflurane Anesthesia in Preschool Children
- ClinicalTrials.gov ID
- NCT07630922
- Acronym / sponsor ID
- Henan-LKR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 5 Jun 2026 (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.
Emergence delirium (ED), characterized by disorientation and altered cognitive behavior, is a common postoperative complication in pediatric surgery. It manifests as lack of eye contact with caregivers or parents, aimless kicking and screaming, and inability to be soothed. Auditory stimulation has been shown to reduce the incidence of ED and postoperative pain during emergence following general anesthesia in children. Therefore, this study aimed to investigate the effects of different types of auditory interventions on the incidence of emergence delirium in children undergoing tonsillectomy and/or adenoidectomy under sevoflurane anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Classical Music Group M: Mozart's Lullaby played continuously during surgery via Bluetooth headphones at 45-60 decibels; Group H (Mother's Heartbeat Recording): Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery; Group S (Mother's Lullaby Recording): Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery; Control Group C: No intervention.
| Arm | Type | Receives |
|---|---|---|
| M Group | Experimental | Other: Classical Music Group |
| H Group | Experimental | Other: Mother's Heartbeat Recording Group |
| S Group | Experimental | Other: Mother's Lullaby Recording Group |
| C Group | No intervention | – |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 3 and 7 years;
- American Society of Anesthesiologists (ASA) physical status classification of I or II;
- Pediatric patients scheduled for elective tonsillectomy and/or adenoidectomy under sevoflurane general anesthesia.
Key exclusion criteria (4 listed)
- Emergency surgery
- The child has developmental delays or neurological disorders, deafness, or hearing impairment
- The mother is deaf or absent
- The patient and family members declined to participate.
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 |
|---|---|---|
| Classical Music GroupRepeatedly played Mozart's Lullaby via Bluetooth headphones at 45-60 at 45-60 dB during surgery | Other | M Group |
| Mother's Heartbeat Recording GroupRepeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery | Other | H Group |
| Mother's Lullaby Recording GroupRepeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery | Other | S Group |
Primary outcome
The incidence of emergence delirium
Time frame: Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed.
According to the Pediatric Anesthesia Emergency Delirium Scale (PAED), the occurrence of ED is defined as a PAED score ≥10 at any time during the PACU period (PAED score range: 0-20).
3 secondary outcomes
The incidence of emergence pain
Time frame: Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed
Incidence of postoperative adverse events
Time frame: Perioperative
PACU Stay Duration
Time frame: From PACU admission to PACU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Related trials for Emergence Delirium, Anesthesia
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Music Group, Mother's Heartbeat Recording Group and Mother's Lullaby Recording Group in people with Emergence Delirium, Anesthesia and Preschool Age Children, run by Henan Provincial People's Hospital at 1 site in China.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of emergence delirium (time frame: Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.